Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. Our objective was to develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. We conducted a consensus meeting with 17 experts in Mississauga, Canada. Experts completed a premeeting survey about whether items in the STROBE statement should be modified or added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not rewording was recommended, and whether additions were warranted. Anonymous voting was used to determine consensus. Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources and measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife.

An Analysis of Marine Mammal Self-Reports and Observer Reports from 1996-2014

NASA Astrophysics Data System (ADS)

McFarland, M. H.

2015-12-01

Over the past two decades commercial fishing vessel owners have been reporting their interactions with marine mammals in accordance with Section 118 of the Marine Mammal Protection Act. The objective of this study is to analyze marine mammal fisheries interactions data from fishermen self-reports and observer reports. We analyzed self-reports from 1996 - 2014 and Pacific Islands observer data from 2001 - 2014, and Northeast observer data from 1996 - 2014. We identify trends in the national marine mammal mortality/injury (M/I) self-report dataset; identify presence of complementary reports between self-reports and observer reports; and determine the compliance rate of self-reports and observer reports. The results of the self-report analysis indicate that the Greater Atlantic Region (GAR) receives the most M/I reports of the five National Marine Fisheries Service (NMFS) regional offices. The rate of animals reported as killed is three times higher than the rate for animals injured. Dolphins and porpoises are the most frequently reported species and gillnets are the most frequently reported gear type. This study will provide fisheries managers a greater understanding of the effectiveness of the requirement for fishermen to report moralities and injuries of marine mammals incidentally taken during commercial fishing operations. Refinements to the Marine Mammal Authorization Program (MMAP) reporting form will provide more accurate estimates of the M/I rate of marine mammals in each region and will help address the challenges with collecting self-reported incidental take data. Furthermore, the results can be used by managers to determine if self-reporting is informative and should be continued, with form improvements made to increase accuracy, or if the corresponding observer reports serve as sufficient data by themselves.

Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-11-01

Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. To develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. Consensus meeting of experts. Mississauga, Canada. Seventeen experts from North America, Europe, and Australia. Experts completed a pre-meeting survey about whether items in the STROBE statement should be modified or added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not rewording was recommended and whether additions were warranted. Anonymous voting was used to determine consensus. Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Evaluation of observational research reports published in Turkish nursing journals.

PubMed

Karaçam, Z; Şen, E; Yildirim, B

2015-09-01

The aim of this literature-based descriptive study was to examine the reporting of the observational research studies published in peer-reviewed nursing journals in Turkey. Eleven peer-reviewed nursing journals printed on a regular basis in Turkey between 2007 and 2012 were selected. These journals were searched for observational research studies, and 502 studies were selected and examined by using the Strengthening the Reporting of Observational Studies in Epidemiology Statement. Of the 502 studies, 495 were cross-sectional, 3 were cohort, and 4 were case controlled. Summary and introduction and aim sections were sufficient in most of the studies. The methods sections of the reports were mostly not reported: 64.3% of the reports did not indicate eligibility/inclusion criteria; sampling method, 67.0%; possible sources of bias, 99.2%; ways to reach sample size, 92.6%. In the results section, the number of individuals participating in each stage of the studies (44.0%) and in other analyses made (39.2%) was not reported. In the discussion section, a main comment about research findings was partly made (97.4%), and limitations of the studies and possible sources of bias were not written in 99.0% of the studies. This study clearly revealed that the observational research studies published in nursing journals in Turkey did not fulfil the important criteria and needed to be improved. Information obtained from this study can contribute to improvement of the quality of reporting observational studies in nursing and thus using obtained findings in practice. © 2015 International Council of Nurses.

Methods and processes of developing the strengthening the reporting of observational studies in epidemiology - veterinary (STROBE-Vet) statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-11-01

The reporting of observational studies in veterinary research presents many challenges that often are not adequately addressed in published reporting guidelines. To develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. A consensus meeting of experts was organized to develop an extension of the STROBE statement to address observational studies in veterinary medicine with respect to animal health, animal production, animal welfare, and food safety outcomes. Consensus meeting May 11-13, 2014 in Mississauga, Ontario, Canada. Seventeen experts from North America, Europe, and Australia attended the meeting. The experts were epidemiologists and biostatisticians, many of whom hold or have held editorial positions with relevant journals. Prior to the meeting, 19 experts completed a survey about whether they felt any of the 22 items of the STROBE statement should be modified and if items should be added to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. At the meeting, the participants were provided with the survey responses and relevant literature concerning the reporting of veterinary observational studies. During the meeting, each STROBE item was discussed to determine whether or not re-wording was recommended, and whether additions were warranted. Anonymous voting was used to determine whether there was consensus for each item change or addition. The consensus was that six items needed no modifications or additions. Modifications or additions were made to the STROBE items numbered: 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14

Explanation and Elaboration Document for the STROBE-Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary Extension.

PubMed

O'Connor, A M; Sargeant, J M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-11-01

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers, and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples, and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE-Vet statement. Thus, this is a companion document to the STROBE-Vet statement methods and process document (JVIM_14575 "Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary (STROBE-Vet) Statement" undergoing proofing), which describes the checklist and how it was developed. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Potential Pitfalls of Reporting and Bias in Observational Studies With Propensity Score Analysis Assessing a Surgical Procedure: A Methodological Systematic Review.

PubMed

Lonjon, Guillaume; Porcher, Raphael; Ergina, Patrick; Fouet, Mathilde; Boutron, Isabelle

2017-05-01

To describe the evolution of the use and reporting of propensity score (PS) analysis in observational studies assessing a surgical procedure. Assessing surgery in randomized controlled trials raises several challenges. Observational studies with PS analysis are a robust alternative for comparative effectiveness research. In this methodological systematic review, we identified all PubMed reports of observational studies with PS analysis that evaluated a surgical procedure and described the evolution of their use over time. Then, we selected a sample of articles published from August 2013 to July 2014 and systematically appraised the quality of reporting and potential bias of the PS analysis used. We selected 652 reports of observational studies with PS analysis. The publications increased over time, from 1 report in 1987 to 198 in 2013. Among the 129 reports assessed, 20% (n = 24) did not detail the covariates included in the PS and 77% (n = 100) did not report a justification for including these covariates in the PS. The rate of missing data for potential covariates was reported in 9% of articles. When a crossover by conversion was possible, only 14% of reports (n = 12) mentioned this issue. For matched analysis, 10% of articles reported all 4 key elements that allow for reproducibility of a PS-matched analysis (matching ratio, method to choose the nearest neighbors, replacement and method for statistical analysis). Observational studies with PS analysis in surgery are increasing in frequency, but specific methodological issues and weaknesses in reporting exist.

Reporting and Methodology of Multivariable Analyses in Prognostic Observational Studies Published in 4 Anesthesiology Journals: A Methodological Descriptive Review.

PubMed

Guglielminotti, Jean; Dechartres, Agnès; Mentré, France; Montravers, Philippe; Longrois, Dan; Laouénan, Cedric

2015-10-01

Prognostic research studies in anesthesiology aim to identify risk factors for an outcome (explanatory studies) or calculate the risk of this outcome on the basis of patients' risk factors (predictive studies). Multivariable models express the relationship between predictors and an outcome and are used in both explanatory and predictive studies. Model development demands a strict methodology and a clear reporting to assess its reliability. In this methodological descriptive review, we critically assessed the reporting and methodology of multivariable analysis used in observational prognostic studies published in anesthesiology journals. A systematic search was conducted on Medline through Web of Knowledge, PubMed, and journal websites to identify observational prognostic studies with multivariable analysis published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anaesthesia, and Anaesthesia in 2010 and 2011. Data were extracted by 2 independent readers. First, studies were analyzed with respect to reporting of outcomes, design, size, methods of analysis, model performance (discrimination and calibration), model validation, clinical usefulness, and STROBE (i.e., Strengthening the Reporting of Observational Studies in Epidemiology) checklist. A reporting rate was calculated on the basis of 21 items of the aforementioned points. Second, they were analyzed with respect to some predefined methodological points. Eighty-six studies were included: 87.2% were explanatory and 80.2% investigated a postoperative event. The reporting was fairly good, with a median reporting rate of 79% (75% in explanatory studies and 100% in predictive studies). Six items had a reporting rate <36% (i.e., the 25th percentile), with some of them not identified in the STROBE checklist: blinded evaluation of the outcome (11.9%), reason for sample size (15.1%), handling of missing data (36.0%), assessment of colinearity (17.4%), assessment of interactions (13.9%), and calibration (34

Evaluating psychiatric case-control studies using the STROBE (STrengthening the Reporting of OBservational Studies in Epidemiology) statement.

PubMed

Goi, Pedro Domingues; Goi, Julia Domingues; Cordini, Kariny Larissa; Ceresér, Keila Mendes; Rocha, Neusa Sica da

2014-01-01

Case-control studies are important in developing clinical and public health knowledge. The STROBE statement (STrengthening the Reporting of OBservational Studies in Epidemiology) was developed to establish a checklist of items that should be included in articles reporting observational studies. Our aim was to analyze whether the psychiatric case-control articles published in Brazilian journals with CAPES Qualis rating B1/B2 in 2009 conformed with the STROBE statement. Descriptive study on psychiatric papers published in Brazilian journals, within the Postgraduate Medical Program on Psychiatry, at Universidade Federal do Rio Grande do Sul. All psychiatric case-control studies from Brazilian Qualis B1/B2 journals of psychiatry, neurology and public health in 2009 were analyzed. The four most specific items of the STROBE statement were used to evaluate whether these studies fitted within the case-control parameters: 1) selection of cases and controls; 2) controlling for bias; 3) statistical analysis; and 4) presentation of results. Sixteen case-control studies were identified, of which eleven (68.75%) were in psychiatry-focused journals. From analysis using the STROBE statement, all of the articles conformed with item 1; two (12.5%) completely conformed with item 2; none completely conformed with item 3; and only three (18.8%) conformed with item 4. The case-control studies analyzed here did not completely conform with the four STROBE statement items for case-control design. In view of the inadequate methodology of the published studies, these findings justify focusing on research and methodology and expanding the investigations on adherence of studies to their designs.

Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report.

PubMed

Berger, Marc L; Dreyer, Nancy; Anderson, Fred; Towse, Adrian; Sedrakyan, Art; Normand, Sharon-Lise

2012-01-01

In both the United States and Europe there has been an increased interest in using comparative effectiveness research of interventions to inform health policy decisions. Prospective observational studies will undoubtedly be conducted with increased frequency to assess the comparative effectiveness of different treatments, including as a tool for "coverage with evidence development," "risk-sharing contracting," or key element in a "learning health-care system." The principle alternatives for comparative effectiveness research include retrospective observational studies, prospective observational studies, randomized clinical trials, and naturalistic ("pragmatic") randomized clinical trials. This report details the recommendations of a Good Research Practice Task Force on Prospective Observational Studies for comparative effectiveness research. Key issues discussed include how to decide when to do a prospective observational study in light of its advantages and disadvantages with respect to alternatives, and the report summarizes the challenges and approaches to the appropriate design, analysis, and execution of prospective observational studies to make them most valuable and relevant to health-care decision makers. The task force emphasizes the need for precision and clarity in specifying the key policy questions to be addressed and that studies should be designed with a goal of drawing causal inferences whenever possible. If a study is being performed to support a policy decision, then it should be designed as hypothesis testing-this requires drafting a protocol as if subjects were to be randomized and that investigators clearly state the purpose or main hypotheses, define the treatment groups and outcomes, identify all measured and unmeasured confounders, and specify the primary analyses and required sample size. Separate from analytic and statistical approaches, study design choices may strengthen the ability to address potential biases and confounding in

Explanation and Elaboration Document for the STROBE-Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary Extension.

PubMed

O'Connor, A M; Sargeant, J M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE-Vet Statement. Thus, this is a companion document to the STROBE-Vet Statement Methods and process document, which describes the checklist and how it was developed. © 2016 The Authors. Zoonoses and Public Health published by Blackwell Verlag GmbH.

Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary (STROBE-Vet) Statement.

PubMed

Sargeant, J M; O'Connor, A M; Dohoo, I R; Erb, H N; Cevallos, M; Egger, M; Ersbøll, A K; Martin, S W; Nielsen, L R; Pearl, D L; Pfeiffer, D U; Sanchez, J; Torrence, M E; Vigre, H; Waldner, C; Ward, M P

2016-12-01

The reporting of observational studies in veterinary research presents many challenges that often are not adequately addressed in published reporting guidelines. A consensus meeting of experts was organized to develop an extension of the STROBE statement to address observational studies in veterinary medicine with respect to animal health, animal production, animal welfare and food safety outcomes. The consensus meeting was held 11-13 May 2014 in Mississauga, Ontario, Canada. Seventeen experts from North America, Europe and Australia attended the meeting. The experts were epidemiologists and biostatisticians, many of whom hold or have held editorial positions with relevant journals. Prior to the meeting, 19 experts completed a survey about whether they felt any of the 22 items of the STROBE statement should be modified and whether items should be added to address unique issues related to observational studies in animal species with health, production, welfare or food safety outcomes. At the meeting, the participants were provided with the survey responses and relevant literature concerning the reporting of veterinary observational studies. During the meeting, each STROBE item was discussed to determine whether or not re-wording was recommended, and whether additions were warranted. Anonymous voting was used to determine whether there was consensus for each item change or addition. The consensus was that six items needed no modifications or additions. Modifications or additions were made to the STROBE items numbered as follows: 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations) and 22 (funding). Published literature was not always available to support modification to, or inclusion of, an item. The methods and processes used in the

Quality Reporting of Multivariable Regression Models in Observational Studies: Review of a Representative Sample of Articles Published in Biomedical Journals.

PubMed

Real, Jordi; Forné, Carles; Roso-Llorach, Albert; Martínez-Sánchez, Jose M

2016-05-01

Controlling for confounders is a crucial step in analytical observational studies, and multivariable models are widely used as statistical adjustment techniques. However, the validation of the assumptions of the multivariable regression models (MRMs) should be made clear in scientific reporting. The objective of this study is to review the quality of statistical reporting of the most commonly used MRMs (logistic, linear, and Cox regression) that were applied in analytical observational studies published between 2003 and 2014 by journals indexed in MEDLINE.Review of a representative sample of articles indexed in MEDLINE (n = 428) with observational design and use of MRMs (logistic, linear, and Cox regression). We assessed the quality of reporting about: model assumptions and goodness-of-fit, interactions, sensitivity analysis, crude and adjusted effect estimate, and specification of more than 1 adjusted model.The tests of underlying assumptions or goodness-of-fit of the MRMs used were described in 26.2% (95% CI: 22.0-30.3) of the articles and 18.5% (95% CI: 14.8-22.1) reported the interaction analysis. Reporting of all items assessed was higher in articles published in journals with a higher impact factor.A low percentage of articles indexed in MEDLINE that used multivariable techniques provided information demonstrating rigorous application of the model selected as an adjustment method. Given the importance of these methods to the final results and conclusions of observational studies, greater rigor is required in reporting the use of MRMs in the scientific literature.

Indicators of hearing protection use: self-report and researcher observation.

PubMed

Griffin, Stephanie C; Neitzel, Richard; Daniell, William E; Seixas, Noah S

2009-10-01

Hearing protection devices (HPD) are commonly used to prevent occupational noise-induced hearing loss. There is a large body of research on hearing protection use in industry, and much of it relies on workers' self-reported use of hearing protection. Based on previous studies in fixed industry, worker self-report has been accepted as an adequate and reliable tool to measure this behavior among workers in many industrial sectors. However, recent research indicates self-reported hearing protection use may not accurately reflect subject behavior in industries with variable noise exposure. This study compares workers' self-reported use of hearing protection with their observed use in three workplaces with two types of noise environments: one construction site and one fixed industry facility with a variable noise environment, and one fixed industry facility with a steady noise environment. Subjects reported their use of hearing protection on self-administered surveys and activity cards, which were validated using researcher observations. The primary outcome of interest in the study was the difference between the self-reported use of hearing protection in high noise on the activity card and survey: (1) over one workday, and (2) over a 2-week period. The primary hypotheses for the study were that subjects in workplaces with variable noise environments would report their use of HPDs less accurately than subjects in the stable noise environment, and that reporting would be less accurate over 2 weeks than over 1 day. In addition to noise variability, other personal and workplace factors thought to affect the accuracy of self-reported hearing protection use were also analyzed. This study found good agreement between subjects' self-reported HPD use and researcher observations. Workers in the steady noise environment self-reported hearing protection use more accurately on the surveys than workers in variable noise environments. The findings demonstrate the potential importance

The Alberta smoke plume observation study

NASA Astrophysics Data System (ADS)

Anderson, Kerry; Pankratz, Al; Mooney, Curtis; Fleetham, Kelly

2018-02-01

A field project was conducted to observe and measure smoke plumes from wildland fires in Alberta. This study used handheld inclinometer measurements and photos taken at lookout towers in the province. Observations of 222 plumes were collected from 21 lookout towers over a 6-year period from 2010 to 2015. Observers reported the equilibrium and maximum plume heights based on the plumes' final levelling heights and the maximum lofting heights, respectively. Observations were tabulated at the end of each year and matched to reported fires. Fire sizes at assessment times and forest fuel types were reported by the province. Fire weather conditions were obtained from the Canadian Wildland Fire Information System (CWFIS). Assessed fire sizes were adjusted to the appropriate size at plume observation time using elliptical fire-growth projections. Though a logical method to collect plume observations in principle, many unanticipated issues were uncovered as the project developed. Instrument limitations and environmental conditions presented challenges to the investigators, whereas human error and the subjectivity of observations affected data quality. Despite these problems, the data set showed that responses to fire behaviour conditions were consistent with the physical processes leading to plume rise. The Alberta smoke plume observation study data can be found on the Canadian Wildland Fire Information System datamart (Natural Resources Canada, 2018) at http://cwfis.cfs.nrcan.gc.ca/datamart.

Seat belt use among rear passengers: validity of self-reported versus observational measures

PubMed Central

Zambon, Francesco; Fedeli, Ugo; Marchesan, Maria; Schievano, Elena; Ferro, Antonio; Spolaore, Paolo

2008-01-01

Background The effects of seat belt laws and public education campaigns on seat belt use are assessed on the basis of observational or self-reported data on seat belt use. Previous studies focusing on front seat occupants have shown that self-reports indicate a greater seat belt usage than observational findings. Whether this over-reporting in self reports applies to rear seat belt usage, and to what extent, have yet to be investigated. We aimed to evaluate the over-reporting factor for rear seat passengers and whether this varies by gender and under different compulsory seat belt use conditions. Methods The study was conducted in the Veneto Region, an area in the North-East of Italy with a population of 4.7 million. The prevalence of seat belt use among rear seat passengers was determined by means of a cross-sectional self-report survey and an observational study. Both investigations were performed in two time periods: in 2003, when rear seat belt use was not enforced by primary legislation, and in 2005, after rear seat belt use had become compulsory (June 2003). Overall, 8138 observations and 7902 interviews were recorded. Gender differences in the prevalence of rear seat belt use were examined using the chi-square test. The over-reporting factor, defined as the ratio of the self-reported to the observed prevalence of rear seat belt use, was calculated by gender before and after the rear seat belt legislation came into effect. Results Among rear seat passengers, self-reported rates were always higher than the observational findings, with an overall over-reporting factor of 1.4. We registered no statistically significant changes over time in the over-reporting factor, nor any major differences between genders. Conclusion Self-reported seat belt usage by rear passengers represents an efficient alternative to observational studies for tracking changes in actual behavior, although the reported figures need to be adjusted using an appropriate over-reporting factor in

Comparison between observed children's tooth brushing habits and those reported by mothers.

PubMed

Martins, Carolina C; Oliveira, Maria J; Pordeus, Isabela A; Paiva, Saul M

2011-09-03

Information bias can occur in epidemiological studies and compromise scientific outcomes, especially when evaluating information given by a patient regarding their own health. The oral habits of children reported by their mothers are commonly used to evaluate tooth brushing practices and to estimate fluoride intake by children. The aim of the present study was to compare observed tooth-brushing habits of young children using fluoridated toothpaste with those reported by mothers. A sample of 201 mothers and their children (aged 24-48 months) from Montes Claros, Brazil, took part in a cross-sectional study. At day-care centres, the mothers answered a self-administered questionnaire on their child's tooth-brushing habits. The structured questionnaire had six items with two to three possible answers. An appointment was then made with each mother/child pair at day-care centres. The participants were asked to demonstrate the tooth-brushing practice as usually performed at home. A trained examiner observed and documented the procedure. Observed tooth brushing and that reported by mothers were compared for overall agreement using Cohen's Kappa coefficient and the McNemar test. Cohen's Kappa values comparing mothers' reports and tooth brushing observed by the examiner ranged from poor-to-good (0.00-0.75). There were statistically significant differences between observed tooth brushing habits and those reported by mothers (p < 0.001). When observed by the examiner, the frequencies of dentifrice dispersed on all bristles (35.9%), children who brushed their teeth alone (33.8%) and those who did not rinse their mouths during brushing (42.0%) were higher than those reported by the mothers (12.1%, 18.9% and 6.5%, respectively; p < 0.001). In general, there was low agreement between observed tooth brushing and mothers' reports. Moreover, the different methods of estimation resulted in differences in the frequencies of tooth brushing habits, indicative of reporting bias. Data

Comparison between observed children's tooth brushing habits and those reported by mothers

PubMed Central

2011-01-01

Background Information bias can occur in epidemiological studies and compromise scientific outcomes, especially when evaluating information given by a patient regarding their own health. The oral habits of children reported by their mothers are commonly used to evaluate tooth brushing practices and to estimate fluoride intake by children. The aim of the present study was to compare observed tooth-brushing habits of young children using fluoridated toothpaste with those reported by mothers. Methods A sample of 201 mothers and their children (aged 24-48 months) from Montes Claros, Brazil, took part in a cross-sectional study. At day-care centres, the mothers answered a self-administered questionnaire on their child's tooth-brushing habits. The structured questionnaire had six items with two to three possible answers. An appointment was then made with each mother/child pair at day-care centres. The participants were asked to demonstrate the tooth-brushing practice as usually performed at home. A trained examiner observed and documented the procedure. Observed tooth brushing and that reported by mothers were compared for overall agreement using Cohen's Kappa coefficient and the McNemar test. Results Cohen's Kappa values comparing mothers' reports and tooth brushing observed by the examiner ranged from poor-to-good (0.00-0.75). There were statistically significant differences between observed tooth brushing habits and those reported by mothers (p < 0.001). When observed by the examiner, the frequencies of dentifrice dispersed on all bristles (35.9%), children who brushed their teeth alone (33.8%) and those who did not rinse their mouths during brushing (42.0%) were higher than those reported by the mothers (12.1%, 18.9% and 6.5%, respectively; p < 0.001). Conclusions In general, there was low agreement between observed tooth brushing and mothers' reports. Moreover, the different methods of estimation resulted in differences in the frequencies of tooth brushing habits

Strengthening the reliability and credibility of observational epidemiology studies by creating an Observational Studies Register.

PubMed

Swaen, Gerard M H; Carmichael, Neil; Doe, John

2011-05-01

To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. The advantages of an OSR outweigh its disadvantages. The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value. Copyright © 2011 Elsevier Inc. All rights reserved.

[How to write high-quality epidemiological research paper Ⅵ. Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut)].

PubMed

Ding, C Y; Cao, Y; Yang, C; Sun, F; Zhan, S Y

2017-01-10

Concerns have been raised about the reporting quality in nutritional epidemiology. Therefore, strengthening the reporting of observational studies in epidemiology-nutritional epidemiology (STROBE-nut) has been proposed by extending the STROBE statement to include additional recommendations on issues related to nutritional epidemiology and dietary assessment, aiming to provide more specific guidelines on how to report observational research in the field. This paper presents a brief introduction to STROBE-nut and also an explanation of the key points in the additional items, with an example illustrating the application of the checklist.

Can Mindful Parenting Be Observed? Relations between Observational Ratings of Mother-Youth Interactions and Mothers’ Self-Report Mindful Parenting

PubMed Central

Duncan, Larissa G.; Coatsworth, J. Douglas; Gayles, Jochebed G.; Geier, Mary H.; Greenberg, Mark T.

2015-01-01

Research on mindful parenting, an extension of mindfulness to the interpersonal domain of parent-child relationships, has been limited by its reliance on self-report assessment. The current study is the first to examine whether observational indices of parent-youth interactions differentiate between high and low levels of self-reported mindful parenting. The Iowa Family Interaction Rating Scales (IFIRS) were used to code interactions between mothers and their 7th grade youth. Mothers drawn from the top and bottom quartiles (n = 375) of a larger distribution of self-reported interpersonal mindfulness in parenting (N = 804) represented clearly defined high and low mindful parenting groups. Discriminant function analysis (DFA) was used to analyze how well six composite IFIRS observational rating variables (e.g., parental warmth, consistent discipline) discriminated between high and low self-reports of mindful parenting. DFA results were cross-validated, with statistically significant canonical correlations found for both subsamples (p < .05). Subsequent independent samples t-tests revealed that group means were significantly different on all six IFIRS composite ratings. Confirmation of the relations between self-report mindful parenting and the observational ratings was also provided through hierarchical regression analyses conducted with a continuous predictor of mindful parenting using the full sample. Thus, the present study provides preliminary evidence for a link between self-reported mindful parenting and observed interactions between parents and youth. PMID:25844494

Case Study Observational Research: A Framework for Conducting Case Study Research Where Observation Data Are the Focus.

PubMed

Morgan, Sonya J; Pullon, Susan R H; Macdonald, Lindsay M; McKinlay, Eileen M; Gray, Ben V

2017-06-01

Case study research is a comprehensive method that incorporates multiple sources of data to provide detailed accounts of complex research phenomena in real-life contexts. However, current models of case study research do not particularly distinguish the unique contribution observation data can make. Observation methods have the potential to reach beyond other methods that rely largely or solely on self-report. This article describes the distinctive characteristics of case study observational research, a modified form of Yin's 2014 model of case study research the authors used in a study exploring interprofessional collaboration in primary care. In this approach, observation data are positioned as the central component of the research design. Case study observational research offers a promising approach for researchers in a wide range of health care settings seeking more complete understandings of complex topics, where contextual influences are of primary concern. Future research is needed to refine and evaluate the approach.

Comparison between self-reported and observed food handling behaviors among Latinas.

PubMed

Dharod, Jigna Morarji; Pérez-Escamilla, Rafael; Paciello, Stefania; Bermúdez-Millán, Angela; Venkitanarayanan, Kumar; Damio, Grace

2007-08-01

The study was conducted to compare and identify the magnitude of differences between self-reported and observed food safety behaviors among women preparing a chicken and salad dish at home. The observed food safety practices also were compared according to sociodemographic variables and prior food safety education. Sixty Puerto Rican women who were the main meal preparers for their households were recruited in Hartford, Conn. Three household visits were made to (i) deliver food ingredients to prepare the chicken and salad meal, (ii) conduct household observation, and (iii) conduct a self-reported survey. The difference between self-reported and observed behaviors varied across food handling and sanitation behaviors. There was a high level of inaccuracy for socially desirable behaviors such as hand washing; the vast majority of participants reported practicing these behaviors but they were not observed doing so. Cutting board washing also was considerably overreported, questioning the validity of these self-reported data for regression analyses. There was a significant association (P < 0.05) between proper thawing method and prior food safety education, use of cutting board and higher income, and washing tomatoes and having a positive attitude towards food safety. Results revealed that overreporting errors must be considered when analyzing and/or interpreting data derived from self-reported food safety consumer surveys and that food safety education and positive food safety attitudes are associated with recommended food safety behaviors.

Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research.

PubMed

Fitchett, Elizabeth J A; Seale, Anna C; Vergnano, Stefania; Sharland, Michael; Heath, Paul T; Saha, Samir K; Agarwal, Ramesh; Ayede, Adejumoke I; Bhutta, Zulfiqar A; Black, Robert; Bojang, Kalifa; Campbell, Harry; Cousens, Simon; Darmstadt, Gary L; Madhi, Shabir A; Meulen, Ajoke Sobanjo-Ter; Modi, Neena; Patterson, Janna; Qazi, Shamim; Schrag, Stephanie J; Stoll, Barbara J; Wall, Stephen N; Wammanda, Robinson D; Lawn, Joy E

2016-10-01

Neonatal infections are estimated to account for a quarter of the 2·8 million annual neonatal deaths, as well as approximately 3% of all disability-adjusted life-years. Despite this burden, few data are available on incidence, aetiology, and outcomes, particularly regarding impairment. We aimed to develop guidelines for improved scientific reporting of observational neonatal infection studies, to increase comparability and to strengthen research in this area. This checklist, Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE- NI), is an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement. STROBE-NI was developed following systematic reviews of published literature (1996-2015), compilation of more than 130 potential reporting recommendations, and circulation of a survey to relevant professionals worldwide, eliciting responses from 147 professionals from 37 countries. An international consensus meeting of 18 participants (with expertise in infectious diseases, neonatology, microbiology, epidemiology, and statistics) identified priority recommendations for reporting, additional to the STROBE statement. Implementation of these STROBE-NI recommendations, and linked checklist, aims to improve scientific reporting of neonatal infection studies, increasing data utility and allowing meta-analyses and pathogen-specific burden estimates to inform global policy and new interventions, including maternal vaccines. Copyright © 2016 Elsevier Ltd. All rights reserved.

Workplace Education Initiative: Case Studies and Observations.

ERIC Educational Resources Information Center

Astrein, Bruce; And Others

Seven workplace education projects funded in the first year of the Massachusetts Workplace Education Initiative are reported. This report includes both general observations and specific information in case studies of the projects. Overall information is provided on students served, the importance of partnerships, the emphasis on…

Observing Protein & Energy Nutrition (OPEN) Study

Cancer.gov

The Observing Protein and Energy Nutrition (OPEN) Study was designed to assess dietary measurement error by comparing results from self-reported dietary intake data with four dietary biomarkers: doubly labeled water and urinary nitrogen, sodium, and potassium.

Proposal for Standardized Tabular Reporting of Observational Surgical Studies Illustrated in a Study on Primary Repair of Bile Duct Injuries.

PubMed

Cho, Jai Young; Jaeger, Allison R; Sanford, Dominic E; Fields, Ryan C; Strasberg, Steven M

2015-09-01

A standard format for reporting observational surgical studies does not exist. This creates difficulties in comparing studies and in performing synthesis through systematic reviews and meta-analyses. This article proposes a method called "standard tabular reporting" and illustrates its use in a case series of bile duct reconstructions for biliary injuries occurring during cholecystectomy. A database dealing with biliary injuries was constructed in sections. Each section was designed to be turned into a table covering one element of the subject. Whenever possible, American College of Surgeons NSQIP "Classic Variables and Definitions" were used for forming sections and tables. However, most tables are original and specific to biliary injury. The database was populated from clinical records of patients who sustained a biliary injury during cholecystectomy. Tables were created dealing with the following subjects: demographics, index operation, presentation, classification of injury, preoperative risk assessment, preoperative laboratory values, operative repair technique, postoperative complications, and long-term outcomes. Between 1997 and 2013, 122 primary bile duct reconstructions were performed, with 1 mortality and 47 complications. Good long-term results were obtained in 113 (92.6%) patients. No secondary surgical reconstructions have been needed. Presentation of data in a standard format would facilitate comparison and synthesis of observational studies on the same subject. The biliary reconstructive methods used resulted in very satisfactory outcomes. Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Work organization in hospital wards and nurses' emotional exhaustion: A multi-method study of observation-based assessment and nurses' self-reports.

PubMed

Stab, Nicole; Hacker, Winfried; Weigl, Matthias

2016-09-01

Ward organization is a major determinant for nurses' well-being on the job. The majority of previous research on this relationship is based on single source methods, which have been criticized as skewed estimations mainly due to subjectivity of the ratings and due to common source bias. To investigate the association of ward organization characteristics and nurses' exhaustion by combining observation-based assessments with nurses' self-reports. Cross-sectional study on 25 wards of four hospitals and 245 nurses. Our multi-method approach to evaluate hospital ward organization consisted of on-site observations with a standardized assessment tool and of questionnaires to evaluate nurses' self-reports and exhaustion. After establishing the reliability of our measures, we applied multi-level regression analyses to determine associations between determinant and outcome variables. We found substantial convergence in ward organization between the observation-based assessments and nurses' self-reports, which supports the validity of our external assessments. Furthermore, two observation-based characteristics, namely participation and patient-focused care, were significantly associated with lower emotional exhaustion among the nurses. Our results suggest that observation-based assessments are a valid and feasible way to assess ward organization in hospitals. Nurses' self-reported as well as observation-based ratings on ward organization were associated with nurses' emotional exhaustion. This is of interest mainly for identifying alternative measures in evaluating nurses' work environments, to inform health promotion activities and to evaluate job redesign intervention. Copyright © 2016 Elsevier Ltd. All rights reserved.

Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

PubMed

Malmivaara, Antti

2016-09-01

Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

Validity of covering-up sun-protection habits: Association of observations and self-report

PubMed Central

O'Riordan, David L.; Nehl, Eric; Gies, Peter; Bundy, Lucja; Burgess, Kristen; Davis, Erica; Glanz, Karen

2013-01-01

Background Few studies have reported the accuracy of measures used to assess sun-protection practices. Valid measures are critical to the internal validity and use of skin cancer control research. Objectives We sought to validate self-reported covering-up practices of pool-goers. Methods A total of 162 lifeguards and 201 parent/child pairs from 16 pools in 4 metropolitan regions in the United States completed a survey and a 4-day sun-habits diary. Observations of sun-protective behaviors were conducted on two occasions. Results Agreement between observations and diaries ranged from slight to substantial, with most values in the fair to moderate range. Highest agreement was observed for parent hat use (κ = 0.58–0.70). There was no systematic pattern of over- or under-reporting among the 3 study groups. Limitations Potential reactivity and a relatively affluent sample are limitations. Conclusion There was little over-reporting and no systematic bias, which increases confidence in reliance on verbal reports of these behaviors in surveys and intervention research. PMID:19278750

Results of Observational Studies: Analysis of Findings from the Nurses’ Health Study

PubMed Central

Tai, Vicky; Grey, Andrew; Bolland, Mark J.

2014-01-01

Background The role of observational studies in informing clinical practice is debated, and high profile examples of discrepancies between the results of observational studies and randomised controlled trials (RCTs) have intensified that debate. We systematically reviewed findings from the Nurses’ Health Study (NHS), one of the longest and largest observational studies, to assess the number and strength of the associations reported and to determine if they have been confirmed in RCTs. Methods We reviewed NHS publication abstracts from 1978–2012, extracted information on associations tested, and graded the strength of the reported effect sizes. We searched PubMed for RCTs or systematic reviews for 3 health outcomes commonly reported in NHS publications: breast cancer, ischaemic heart disease (IHD) and osteoporosis. NHS results were compared with RCT results and deemed concordant when the difference in effect sizes between studies was ≤0.15. Findings 2007 associations between health outcomes and independent variables were reported in 1053 abstracts. 58.0% (1165/2007) were statistically significant, and 22.2% (445/2007) were neutral (no association). Among the statistically significant results that reported a numeric odds ratio (OR) or relative risk (RR), 70.5% (706/1002) reported a weak association (OR/RR 0.5–2.0), 24.5% (246/1002) a moderate association (OR/RR 0.25–0.5 or 2.0–4.0) and 5.0% (50/1002) a strong association (OR/RR ≤0.25 or ≥4.0). 19 associations reported in NHS publications for breast cancer, IHD and osteoporosis have been tested in RCTs, and the concordance between NHS and RCT results was low (≤25%). Conclusions NHS publications contain a large number of analyses, the majority of which reported statistically significant but weak associations. Few of these associations have been tested in RCTs, and where they have, the agreement between NHS results and RCTs is poor. PMID:25330007

Contextual Influences on Concordance between Maternal Report and Laboratory Observation of Toddler Fear

PubMed Central

Kiel, Elizabeth J.; Hummel, Alexandra C.

2016-01-01

Emotion and temperament researchers have faced an enduring issue of how to best measure children’s tendencies to express specific emotions. Inconsistencies between laboratory observation and parental report have made it challenging for researchers to determine the utility of these different forms of measurement. The current study examined the effect of laboratory episode characteristics (i.e., threat-level of the episode, maternal involvement) on concordance between maternal report and laboratory observation of toddler fear. The sample included 111 mother-toddler dyads who participated in a laboratory assessment when toddlers were approximately 24-months-old. Toddler fear was assessed both via maternal report and observation from a number of laboratory episodes that varied in their level of threat and whether mothers were free or constrained in their involvement in the task. Results indicated that maternal report related to the observed fear composites for low-threat, but not high-threat episodes. On the other hand, maternal involvement in the laboratory episodes did not moderate the relation between maternal report and laboratory observation of fear. These results suggest that the threat-level of laboratory episodes designed to elicit fear, but not maternal involvement in these episodes, may be important to take into consideration when assessing their relation to maternal report of fear and fearful temperament. PMID:27606826

A comparison of self-report and direct observation of booster seat use in Latino families.

PubMed

Quistberg, D Alex; Lozano, Paula; Mack, Christopher D; Schwartz, Rachel; Ebel, Beth E

2010-08-01

To develop a reliable self-report tool for measuring child booster seat use among Latino families. Cross-sectional and observational survey of a convenience sample. Five retail stores in King County, Washington. 50 parents of children 4-8 years old that self-identified as Latino or Hispanic. Parent-reported measures of how often the child uses a booster seat, if the child used a booster seat on the last trip, how often the child complains about using a booster seat, how often the child asks to not use a booster seat, and how often other families they know use a booster seat. Observed booster seat use by child. 26 children (52%) were observed using a booster seat. Parent-reported booster seat use was a poor predictor of observed booster seat use. Although 34 parents reported that their child 'always' uses a booster seat, 8 (24%) of these children were not using a booster seat. A logistic model to predict booster seat use had a sensitivity of 81% and a specificity of 71%, and misclassified 24% of the participants' observed use. Reliance on parent-reported booster seat use significantly overstated observed booster seat use in the study. Among this study population, accurate determination of booster seat use required direct observation.

Prevalence and correlates of self-reported sexual dysfunction in CKD: a meta-analysis of observational studies.

PubMed

Navaneethan, Sankar D; Vecchio, Mariacristina; Johnson, David W; Saglimbene, Valeria; Graziano, Giusi; Pellegrini, Fabio; Lucisano, Giuseppe; Craig, Jonathan C; Ruospo, Marinella; Gentile, Giorgio; Manfreda, Valeria Maria; Querques, Marialuisa; Stroumza, Paul; Torok, Marietta; Celia, Eduardo; Gelfman, Ruben; Ferrari, Juan Nin; Bednarek-Skublewska, Anna; Dulawa, Jan; Bonifati, Carmen; Hegbrant, Jörgen; Wollheim, Charlotta; Jannini, Emmanuele A; Strippoli, Giovanni F M

2010-10-01

Sexual dysfunction is an under-recognized problem in men and women with chronic kidney disease (CKD). The prevalence, correlates, and predictors of this condition in patients with CKD have not been evaluated comprehensively. Systematic review and meta-analysis. Patients treated using dialysis (dialysis patients), patients treated using transplant (transplant recipients), and patients with CKD not treated using dialysis or transplant (nondialysis nontransplant patients with CKD). Observational studies conducted in patients with CKD only or including a control group without CKD. Type of study population. Sexual dysfunction in men and women with CKD using validated tools, such as the International Index of Erectile Function, the Female Sexual Function Index (FSFI), or other measures as reported by study investigators. 50 studies (8,343 patients) of variable size (range, 16-1,023 patients) were included in this review. Almost all studies explored sexual dysfunction in men and specifically erectile dysfunction. The summary estimate of erectile dysfunction in men with CKD was 70% (95% CI, 62%-77%; 21 studies, 4,389 patients). Differences in reported prevalence rates of erectile dysfunction between different studies were attributable primarily to age, study populations, and type of study tool used to assess the presence of erectile dysfunction. In women, the reported prevalence of sexual dysfunction was assessed in only 306 patients from 2 studies and ranged from 30%-80%. Compared with the general population, women with CKD had a significantly lower overall FSFI score (8 studies or subgroups, 407 patients; mean difference, -9.28; 95% CI, -12.92 to -5.64). Increasing age, diabetes mellitus, and depression consistently were found to correlate with sexual dysfunction in 20 individual studies of patients with CKD using different methods. Suboptimal and lack of uniform assessment of outcome measures. Sexual dysfunction is highly prevalent in both men and women with CKD

Observed and Self-Reported Pesticide Protective Behaviors of Latino Migrant and Seasonal Farmworkers

PubMed Central

Walton, AnnMarie Lee; LePrevost, Catherine; Wong, Bob; Linnan, Laura; Sanchez-Birkhead, Ana; Mooney, Kathi

2016-01-01

Agricultural pesticide exposure has potential adverse health effects for farmworkers that may be reduced by pesticide protective behaviors (PPBs). The Environmental Protection Agency’s (EPA) Worker Protection Standard (WPS) requires PPBs be taught to farmworkers prior to field work. Studies to date have not utilized observational methods to evaluate the degree to which PPBs are practiced by Latino migrant and seasonal farmworkers in the United States. The purpose of this study was to describe, compare, and contrast observed and self-reported PPBs used by Latino farmworkers; both PPBs that the WPS requires be taught and other PPBs were included. Observed and self-reported data were collected from 71 Latino farmworkers during the 2014 tobacco growing season in North Carolina. Participants were consistent in reporting and using long pants and closed shoes in the field most of the time. In addition, gloves, hats/bandanas, and water-resistant outerwear were frequently observed, although they are not required to be taught by the WPS. Farmworkers reported more long-sleeve (p = .028) and glove use (p = .000) than what was observed. It was uncommon to observe washing behavior before eating or drinking, even when washing supplies were available. Washing behaviors were significantly overreported for hand (p = .000; (p = .000) and face (p = .000; (p = .058) washing before eating and drinking in the field. This study documents that protective clothing behaviors that the WPS requires be taught, plus a few others are commonly practiced by Latino migrant and seasonal farmworkers, but washing behaviors in the field are not. Targeted strategies to improve washing behaviors in the field are needed. PMID:26918841

Impact of STROBE statement publication on quality of observational study reporting: interrupted time series versus before-after analysis.

PubMed

Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence

2013-01-01

In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series. For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥ 4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007) and one post STROBE period (2008-2010). Segmented regression analysis of interrupted time series was also performed. Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%-98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-05 48% versus median score2008-10 58%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-07 58% versus median score2008-10 58%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p = 0.64) in the post STROBE statement publication. The quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before

Patient reported outcome of adult perioperative anaesthesia in the United Kingdom: a cross-sectional observational study.

PubMed

Walker, E M K; Bell, M; Cook, T M; Grocott, M P W; Moonesinghe, S R

2016-06-12

Understanding the patient perspective on healthcare is central to the evaluation of quality. This study measured selected patient-reported outcomes after anaesthesia in order to identify targets for research and quality improvement. This cross-sectional observational study in UK National Health Service hospitals, recruited adults undergoing non-obstetric surgery requiring anaesthesia care over a 48 h period. Within 24 h of surgery, patients completed the Bauer questionnaire (measuring postoperative discomfort and satisfaction with anaesthesia care), and a modified Brice questionnaire to elicit symptoms suggestive of accidental awareness during general anaesthesia (AAGA). Patient, procedural and pharmacological data were recorded to enable exploration of risk factors for these poor outcomes. 257 hospitals in 171 NHS Trusts participated (97% of eligible organisations). Baseline characteristics were collected on 16,222 patients; 15,040 (93%) completed postoperative questionnaires. Anxiety was most frequently cited as the worst aspect of the perioperative experience. Thirty-five per cent of patients reported severe discomfort in at least one domain: thirst (18.5%; 95% CI 17.8-19.1), surgical pain (11.0%; 10.5-11.5) and drowsiness (10.1%; 9.6-10.5) were most common. Despite this, only 5% reported dissatisfaction with any aspect of anaesthesia-related care. Regional anaesthesia was associated with a reduced burden of side-effects. The incidence of reported AAGA was one in 800 general anaesthetics (0.12%) Anxiety and discomfort after surgery are common; despite this, satisfaction with anaesthesia care in the UK is high. The inconsistent relationship between patient-reported outcome, patient experience and patient satisfaction supports using all three of these domains to provide a comprehensive assessment of the quality of anaesthesia care. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For

Exploring Differences in Measurement and Reporting of Classroom Observation Inter-Rater Reliability

ERIC Educational Resources Information Center

Wilhelm, Anne Garrison; Gillespie Rouse, Amy; Jones, Francesca

2018-01-01

Although inter-rater reliability is an important aspect of using observational instruments, it has received little theoretical attention. In this article, we offer some guidance for practitioners and consumers of classroom observations so that they can make decisions about inter-rater reliability, both for study design and in the reporting of data…

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study

PubMed Central

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-01-01

Objectives We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. Methods A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. Results At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Conclusions Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. Trial registration number NCT01794715; Results PMID:28320791

Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. Aims: To create and pilot test a checklist for appraising methodological validity of a BCT. Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.Key messagesBenchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. PMID:27238631

Self-reported empathy and neural activity during action imitation and observation in schizophrenia

PubMed Central

Horan, William P.; Iacoboni, Marco; Cross, Katy A.; Korb, Alex; Lee, Junghee; Nori, Poorang; Quintana, Javier; Wynn, Jonathan K.; Green, Michael F.

2014-01-01

Introduction Although social cognitive impairments are key determinants of functional outcome in schizophrenia their neural bases are poorly understood. This study investigated neural activity during imitation and observation of finger movements and facial expressions in schizophrenia, and their correlates with self-reported empathy. Methods 23 schizophrenia outpatients and 23 healthy controls were studied with functional magnetic resonance imaging (fMRI) while they imitated, executed, or simply observed finger movements and facial emotional expressions. Between-group activation differences, as well as relationships between activation and self-reported empathy, were evaluated. Results Both patients and controls similarly activated neural systems previously associated with these tasks. We found no significant between-group differences in task-related activations. There were, however, between-group differences in the correlation between self-reported empathy and right inferior frontal (pars opercularis) activity during observation of facial emotional expressions. As in previous studies, controls demonstrated a positive association between brain activity and empathy scores. In contrast, the pattern in the patient group reflected a negative association between brain activity and empathy. Conclusions Although patients with schizophrenia demonstrated largely normal patterns of neural activation across the finger movement and facial expression tasks, they reported decreased self perceived empathy and failed to show the typical relationship between neural activity and self-reported empathy seen in controls. These findings suggest that patients show a disjunction between automatic neural responses to low level social cues and higher level, integrative social cognitive processes involved in self-perceived empathy. PMID:25009771

Self-reported empathy and neural activity during action imitation and observation in schizophrenia.

PubMed

Horan, William P; Iacoboni, Marco; Cross, Katy A; Korb, Alex; Lee, Junghee; Nori, Poorang; Quintana, Javier; Wynn, Jonathan K; Green, Michael F

2014-01-01

Although social cognitive impairments are key determinants of functional outcome in schizophrenia their neural bases are poorly understood. This study investigated neural activity during imitation and observation of finger movements and facial expressions in schizophrenia, and their correlates with self-reported empathy. 23 schizophrenia outpatients and 23 healthy controls were studied with functional magnetic resonance imaging (fMRI) while they imitated, executed, or simply observed finger movements and facial emotional expressions. Between-group activation differences, as well as relationships between activation and self-reported empathy, were evaluated. Both patients and controls similarly activated neural systems previously associated with these tasks. We found no significant between-group differences in task-related activations. There were, however, between-group differences in the correlation between self-reported empathy and right inferior frontal (pars opercularis) activity during observation of facial emotional expressions. As in previous studies, controls demonstrated a positive association between brain activity and empathy scores. In contrast, the pattern in the patient group reflected a negative association between brain activity and empathy. Although patients with schizophrenia demonstrated largely normal patterns of neural activation across the finger movement and facial expression tasks, they reported decreased self perceived empathy and failed to show the typical relationship between neural activity and self-reported empathy seen in controls. These findings suggest that patients show a disjunction between automatic neural responses to low level social cues and higher level, integrative social cognitive processes involved in self-perceived empathy.

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study.

PubMed

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-03-20

We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. NCT01794715; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Recommended observational skills training for IAEA safeguards inspections. Final report: Recommended observational skills training for IAEA safeguards inspections

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

Toquam, J.L.; Morris, F.A.

This is the second of two reports prepared to assist the International Atomic Energy Agency (IAEA or Agency) in enhancing the effectiveness of its international safeguards inspections through inspector training in {open_quotes}Observational Skills{close_quotes}. The first (Phase 1) report was essentially exploratory. It defined Observational Skills broadly to include all appropriate cognitive, communications, and interpersonal techniques that have the potential to help IAEA safeguards inspectors function more effectively. It identified 10 specific Observational Skills components, analyzed their relevance to IAEA safeguards inspections, and reviewed a variety of inspection programs in the public and private sectors that provide training in one ormore » more of these components. The report concluded that while it should be possible to draw upon these other programs in developing Observational Skills training for IAEA inspectors, the approaches utilized in these programs will likely require significant adaption to support the specific job requirements, policies, and practices that define the IAEA inspector`s job. The overall objective of this second (Phase 2) report is to provide a basis for the actual design and delivery of Observational Skills training to IAEA inspectors. The more specific purposes of this report are to convey a fuller understanding of the potential application of Observational Skills to the inspector`s job, describe inspector perspectives on the relevance and importance of particular Observational Skills, identify the specific Observational Skill components that are most important and relevant to enhancing safeguards inspections, and make recommendations as to Observational Skills training for the IAEA`s consideration in further developing its Safeguards training program.« less

Impact of STROBE Statement Publication on Quality of Observational Study Reporting: Interrupted Time Series versus Before-After Analysis

PubMed Central

Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence

2013-01-01

Background In uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series. Methods For this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (≥4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004–2005 and 2006–2007) and one post STROBE period (2008–2010). Segmented regression analysis of interrupted time series was also performed. Results Of the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%–98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004–05 48% versus median score2008–10 58%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006–07 58% versus median score2008–10 58%, p = 0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p = 0.016). By segmented analysis, no significant changes in STROBE score trends occurred (−0.40%; 95%CI, −2.20 to 1.41; p = 0.64) in the post STROBE statement publication. Interpretation The quality of reports increased over time but was not affected by STROBE. Our findings raise

Procedures for Classroom Observations: 1973-1974. Technical Report #19.

ERIC Educational Resources Information Center

Miley, Alan

This report describes classroom observation techniques used to record the behavior of educational specialists (teachers) and students in a kindergarten and a first grade classroom of the Kamehameha Early Education Program (KEEP). Classroom behavior was observed and recorded daily during the 1973-1974 school year. Each student was observed three…

A comparison of observers' and self-report pain ratings for children with cerebral palsy.

PubMed

Hadden, Kellie L; LeFort, Sandra; OʼBrien, Michelle; Coyte, Peter C; Guerriere, Denise N

2015-01-01

This study aimed to examine (1) the relationship between children's self-reports of pain and their different care providers' pain ratings, (2) the relationship between different care providers' ratings of pain in children with cerebral palsy (CP), and (3) whether the child's level of disability influences care providers' pain ratings. Sixty-three children with CP were separated into 2 groups according to whether they were able to pass a self-report training task. Pain was rated using a Numerical Rating Scale and the Non-Communicating Children's Pain Checklist-Postoperative Version (NCCPC-PV). Children were observed during their regular physiotherapy sessions at 3 separate time segments (Baseline, Stretch Procedure, and Recovery). As anticipated, results showed that all observers reported significantly higher pain scores during a physiotherapy stretching procedure than the baseline and recovery segments. Observers' NCCPC-PV scores were significantly higher during the stretch procedure for the children who did not pass the self-report training task. Findings also indicated that parents tended to report significantly lower pain scores compared with both their children and other observers. The findings bring into question the accuracy of single-observer pain ratings for children with CP and possess implications for the management of pain in children with CP.

Stimulating Interest in Natural Sciences and Training Observation Skills: The UAP Observations Reporting Scheme

NASA Astrophysics Data System (ADS)

Ailleris, P.

2012-04-01

how to record as accurately as possible a UAP event, in order to facilitate future identification and study. Lastly, one of the project's objectives is also to collect reports of trained observers (astronomers) of apparently inexplicable events for further analysis. Certainly, whenever there are unexplained observations there is the possibility that scientists could learn something new by studying these events. During this presentation, we will provide an overview of the project, present the website's extensive and well illustrated list of misidentifications, describe how people can further check details, develop their knowledge (e.g. satellite paths, stars/planets charts, characteristics of meteors, pictures of sprites, clouds classification) and enhance their observation skills. In order to show the relevance of the project, a short illustrated list of UAP cases received by the project will be featured, both explained and inexplicable. Finally, we will explore potential plans for strengthening the visibility and usefulness of the project, while requesting feedback from the community of atmospheric and natural sciences' researchers. (1) www.uapreporting.org (*): Disclaimer: Work undertaken as personal work; not endorsed as research activity by ESA.

The Dominance Behavioral System and Psychopathology: Evidence from Self-Report, Observational, and Biological Studies

PubMed Central

Johnson, Sheri L.; Leedom, Liane J.; Muhtadie, Luma

2012-01-01

The dominance behavioral system (DBS) can be conceptualized as a biologically-based system which guides dominance motivation, dominant and subordinate behavior, and responsivity to perceptions of power and subordination. A growing body of research suggests that problems with the DBS are evident across a broad range of psychopathologies. We begin by describing psychological, social, and biological correlates of the dominance behavioral system (DBS). Extensive research suggests that externalizing disorders, mania-proneness, and narcissistic traits are related to heightened dominance motivation and behaviors. Mania and narcissistic traits also appear related to inflated self-perceptions of power. Anxiety and depression are related to subordination and submissiveness, as well as a desire to avoid subordination. Models of the DBS have received support from research with humans and animals; from self-report, observational, and biological methods; and using naturalistic and experimental paradigms. Limitations of available research include the relative lack of longitudinal studies using multiple measures of the DBS and the absence of relevant studies using diagnosed samples to study narcissistic personality disorder and bipolar disorder. We provide suggestions for future research on the DBS and psychopathology, including investigations of whether the DBS can be used to differentiate specific disorder outcomes; the need for more sophisticated biological research; and the value of longitudinal dynamical research. Implications of using the DBS as a tool in clinical assessment and treatment are discussed. PMID:22506751

Are parent-reported outcomes for self-directed or telephone-assisted behavioral family intervention enhanced if parents are observed?

PubMed

Morawska, Alina; Sanders, Matthew R

2007-05-01

The study examined the effects of conducting observations as part of a broader assessment of families participating in behavior family intervention (BFI). It was designed to investigate whether the observations improve intervention outcomes. Families were randomly assigned to different levels of BFI or a waitlist control condition and subsequently randomly assigned to either observation or no-observation conditions. This study demonstrated significant intervention and observation effects. Mothers in more intensive BFI reported more improvement in their child's behavior and their own parenting. Observed mothers reported lower intensity of child behavior problems and more effective parenting styles. There was also a trend for less anger among mothers who were observed and evidence of an observation-intervention interaction for parental anger, with observed mothers in more intensive intervention reporting less anger compared to those not observed. Implications for clinical and research intervention contexts are discussed.

Observations on the Relations Between Education and Work in the People's Republic of China: Report of a Study Group, April 25 to May 15, 1978. Extended Version.

ERIC Educational Resources Information Center

Kerr, Clark; And Others

This is a report of the observations and activities of a group of Americans who visited China to study the Chinese attempt to integrate education with work. As well as general observations by the 22 group members, accounts are included of visits made to specific schools and workplaces. In addition, the report contains a background paper on…

The value of including observational studies in systematic reviews was unclear: a descriptive study.

PubMed

Seida, Jennifer; Dryden, Donna M; Hartling, Lisa

2014-12-01

To evaluate (1) how often observational studies are included in comparative effectiveness reviews (CERs); (2) the rationale for including observational studies; (3) how data from observational studies are appraised, analyzed, and graded; and (4) the impact of observational studies on strength of evidence (SOE) and conclusions. Descriptive study of 23 CERs published through the Effective Health Care Program of the U.S. Agency for Healthcare Research and Quality. Authors searched for observational studies in 20 CERs, of which 18 included a median of 11 (interquartile range, 2-31) studies. Sixteen CERs incorporated the observational studies in their SOE assessments. Seventy-eight comparisons from 12 CERs included evidence from both trials and observational studies; observational studies had an impact on SOE and conclusions for 19 (24%) comparisons. There was diversity across the CERs regarding decisions to include observational studies; study designs considered; and approaches used to appraise, synthesize, and grade SOE. Reporting and methods guidance are needed to ensure clarity and consistency in how observational studies are incorporated in CERs. It was not always clear that observational studies added value in light of the additional resources needed to search for, select, appraise, and analyze such studies. Copyright © 2014 Elsevier Inc. All rights reserved.

Relation between Direct Observation of Relaxation and Self-Reported Mindfulness and Relaxation States

ERIC Educational Resources Information Center

Hites, Lacey S.; Lundervold, Duane A.

2013-01-01

Forty-four individuals, 18-47 (MN 21.8, SD 5.63) years of age, took part in a study examining the magnitude and direction of the relationship between self-report and direct observation measures of relaxation and mindfulness. The Behavioral Relaxation Scale (BRS), a valid direct observation measure of relaxation, was used to assess relaxed behavior…

A metadata reporting framework (FRAMES) for synthesis of ecohydrological observations

DOE PAGES

Christianson, Danielle S.; Varadharajan, Charuleka; Christoffersen, Bradley; ...

2017-06-20

Metadata describe the ancillary information needed for data interpretation, comparison across heterogeneous datasets, and quality control and quality assessment (QA/QC). Metadata enable the synthesis of diverse ecohydrological and biogeochemical observations, an essential step in advancing a predictive understanding of earth systems. Environmental observations can be taken across a wide range of spatiotemporal scales in a variety of measurement settings and approaches, and saved in multiple formats. Thus, well-organized, consistent metadata are required to produce usable data products from diverse observations collected in disparate field sites. However, existing metadata reporting protocols do not support the complex data synthesis needs of interdisciplinarymore » earth system research. We developed a metadata reporting framework (FRAMES) to enable predictive understanding of carbon cycling in tropical forests under global change. FRAMES adheres to best practices for data and metadata organization, enabling consistent data reporting and thus compatibility with a variety of standardized data protocols. We used an iterative scientist-centered design process to develop FRAMES. The resulting modular organization streamlines metadata reporting and can be expanded to incorporate additional data types. The flexible data reporting format incorporates existing field practices to maximize data-entry efficiency. With FRAMES’s multi-scale measurement position hierarchy, data can be reported at observed spatial resolutions and then easily aggregated and linked across measurement types to support model-data integration. FRAMES is in early use by both data providers and users. Here in this article, we describe FRAMES, identify lessons learned, and discuss areas of future development.« less

A metadata reporting framework (FRAMES) for synthesis of ecohydrological observations

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

Christianson, Danielle S.; Varadharajan, Charuleka; Christoffersen, Bradley

Metadata describe the ancillary information needed for data interpretation, comparison across heterogeneous datasets, and quality control and quality assessment (QA/QC). Metadata enable the synthesis of diverse ecohydrological and biogeochemical observations, an essential step in advancing a predictive understanding of earth systems. Environmental observations can be taken across a wide range of spatiotemporal scales in a variety of measurement settings and approaches, and saved in multiple formats. Thus, well-organized, consistent metadata are required to produce usable data products from diverse observations collected in disparate field sites. However, existing metadata reporting protocols do not support the complex data synthesis needs of interdisciplinarymore » earth system research. We developed a metadata reporting framework (FRAMES) to enable predictive understanding of carbon cycling in tropical forests under global change. FRAMES adheres to best practices for data and metadata organization, enabling consistent data reporting and thus compatibility with a variety of standardized data protocols. We used an iterative scientist-centered design process to develop FRAMES. The resulting modular organization streamlines metadata reporting and can be expanded to incorporate additional data types. The flexible data reporting format incorporates existing field practices to maximize data-entry efficiency. With FRAMES’s multi-scale measurement position hierarchy, data can be reported at observed spatial resolutions and then easily aggregated and linked across measurement types to support model-data integration. FRAMES is in early use by both data providers and users. Here in this article, we describe FRAMES, identify lessons learned, and discuss areas of future development.« less

Accuracy of self-reported drinking: observational verification of 'last occasion' drink estimates of young adults.

PubMed

Northcote, Jeremy; Livingston, Michael

2011-01-01

As a formative step towards determining the accuracy of self-reported drinking levels commonly used for estimating population alcohol use, the validity of a 'last occasion' self-reporting approach is tested with corresponding field observations of participants' drinking quantity. This study is the first known attempt to validate the accuracy of self-reported alcohol consumption using data from a natural setting. A total of 81 young adults (aged 18-25 years) were purposively selected in Perth, Western Australia. Participants were asked to report the number of alcoholic drinks consumed at nightlife venues 1-2 days after being observed by peer-based researchers on 239 occasions. Complete observation data and self-report estimates were available for 129 sessions, which were fitted with multi-level models assessing the relationship between observed and reported consumption. Participants accurately estimated their consumption when engaging in light to moderate drinking (eight or fewer drinks in a single session), with no significant difference between the mean reported consumption and the mean observed consumption. In contrast, participants underestimated their own consumption by increasing amounts when engaging in heavy drinking of more than eight drinks. It is suggested that recent recall methods in self-report surveys are potentially reasonably accurate measures of actual drinking levels for light to moderate drinkers, but that underestimating of alcohol consumption increases with heavy consumption. Some of the possible reasons for underestimation of heavy drinking are discussed, with both cognitive and socio-cultural factors considered.

Post-fall reporting in aged acute inpatient mental health units: an 18-month observational cohort study.

PubMed

Furness, Trentham; Mnatzaganian, George; Garlick, Robyn; Ireland, Susan; McKenna, Brian; Hill, Keith D

2017-12-01

Despite the high risk of falling for people with severe mental illness, there is limited falls research in mental health settings. Therefore, the objective of this observational cohort study was to conduct a focused post-fall review of fall episodes within aged acute inpatient mental health units at one of Australia's largest publicly funded mental health organizations. A post-fall reporting tool was developed to collect intrinsic and extrinsic fall risk factors among three aged acute mental health inpatient units over an 18-month period. Descriptive and inferential analyses were conducted to describe fall risk factors and predictors of fall risk. There were a total of 115 falls, of which the tool was used for 93 (80.9%) episodes. Falls occurred most often in consumer's bedroom/bathroom and were unwitnessed. Intrinsic risk factors were most often attributed to postural drop and losing balance during walking. However, that was in contrast to consumer's who self-reported feeling dizzy as the reason of the fall. Based on the cohort, future falls could be reduced by targeting those aged above 82 years, or with a diagnosis of dementia. Recurrent falls during admission could be reduced by targeting those with psychotic illness and males with a diagnosis of dementia. A clearer dialogue among consumers and clinical staff reporting about fall episodes may support future remedial interventions and inform programs to reduce fall risk and assist the challenge of describing unwitnessed falls in aged acute inpatient mental health settings.

The relation between child feeding problems as measured by parental report and mealtime behavior observation: A pilot study.

PubMed

van Dijk, Marijn; Bruinsma, Eke; Hauser, M Paulina

2016-04-01

Because feeding problems have clear negative consequences for both child and caretakers, early diagnosis and intervention are important. Parent-report questionnaires can contribute to early identification, because they are efficient and typically offer a 'holistic' perspective of the child's eating in different contexts. In this pilot study, we aim to explore the concurrent validity of a short screening instrument (the SEP, which is the Dutch MCH-FS) in one of its target populations (a group of premature children) by comparing the total score with the observed behavior of the child and caretaker during a regular home meal. 28 toddlers (aged 9-18 months) and their caretakers participated in the study. Video-observations of the meals were coded for categories of eating behavior and parent-child interaction. The results show that the total SEP-score correlates with food refusal, feeding efficiency, and self-feeding, but not with negative affect and parental instructions. This confirms that the SEP has a certain degree of concurrent validity in the sense that its total score is associated with specific 'benchmark' feeding behaviors: food refusal, feeding efficiency and autonomy. Future studies with larger samples are needed to generalize the findings from this pilot to a broader context. Copyright © 2016 Elsevier Ltd. All rights reserved.

Direct observation of students during clerkship rotations: a multiyear descriptive study.

PubMed

Howley, Lisa D; Wilson, William G

2004-03-01

To determine how often students report that they are observed while performing physical examinations and taking histories during clerkship rotations. From 1999-2001, 397 students at the University of Virginia School of Medicine were asked at the end of their third year to report the number of times they had been observed by a resident or faculty member while taking histories and performing physical examinations on six rotations. Three hundred and forty-five students (87%) returned the survey instrument; of these, 322 (81%) returned instruments with complete information. On average, the majority reported that they had never been observed by a faculty member while taking a history (51%), performing a focused physical examination (54%), or a complete physical examination (81%). The majority (60%) reported that they had never been observed by a resident while performing a complete physical examination. Faculty observations occurred most frequently during the four-week family medicine rotation and least frequently during the 12-week surgery rotation. The length of the clerkship rotation was inversely related to the number of reported observations, chi(2) (5, n = 295) = 127.85, p <.000. Although alternative assessments of clinical skills are becoming more common in medical education, faculty ratings based on direct observation are still prominent. The data in this study reflect that these observations may actually be occurring quite infrequently, if at all. Decreasing the evaluative weight of faculty and resident ratings during the clerkship rotation may be necessary. Otherwise, efforts should be made to increase the validity of these ratings.

Observational Studies: Cohort and Case-Control Studies

PubMed Central

Song, Jae W.; Chung, Kevin C.

2010-01-01

Observational studies are an important category of study designs. To address some investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct. Instead, observational studies may be the next best method to address these types of questions. Well-designed observational studies have been shown to provide results similar to randomized controlled trials, challenging the belief that observational studies are second-rate. Cohort studies and case-control studies are two primary types of observational studies that aid in evaluating associations between diseases and exposures. In this review article, we describe these study designs, methodological issues, and provide examples from the plastic surgery literature. PMID:20697313

An Experimental Investigation of Drunk Personality Using Self and Observer Reports

PubMed Central

Winograd, Rachel P.; Steinley, Douglas; Lane, Sean P.; Sher, Kenneth J.

2017-01-01

Across various cultures there are robust stereotypes regarding how alcohol intoxication alters individuals’ normative personalities. However, whether these stereotypes are rooted in genuine average effects or in salient, socially-proliferated exemplars remain unclear. The current study tested if differences between sober and intoxicated personality expression can be observed reliably by trained raters during a drinking episode. Participants (N = 156), half of whom received alcohol, attended laboratory sessions in same-gender friend groups and engaged in activities designed to elicit a range of personality expression. Participants completed self-reports of their “typical” sober and drunk personalities two weeks prior to their sessions and via two short measures during the session. Additionally, participants were recorded and rated by multiple (Range = 5–17) trained raters using three personality measures. Self-perceptions of sober-to-drunk personality differences were more pervasive than observer-perceptions, but alcohol-induced changes in Extraversion, specifically, were robust across measures and reporters. PMID:28785511

Kindergarteners’ Self-Reported Social Inhibition and Observed Social Reticence: Moderation by Adult-Reported Social Inhibition and Social Anxiety Disorder Symptoms

PubMed Central

Kiel, Elizabeth J.; Buss, Kristin A.; Molitor, Joseph G.

2014-01-01

Prevention of later anxiety problems would best be accomplished by identifying at-risk children early in development. For example, children who develop Social Anxiety Disorder (SAD) may show social withdrawal in the form of social inhibition (i.e., shyness with unfamiliar adults and peers) at school entry. Although the use of children’s perceptions of their own social inhibition would provide insight into early risk, the utility of young children’s self-reports remains unclear. The current study examined whether children deemed more extreme on social inhibition or social anxiety by adult report provided self-report of social inhibition that related to observed social reticence in the laboratory. Participants included 85 kindergarten children (36 female, 49 male), their parents, and their teachers. Moderation analyses revealed that children’s self-reported social inhibition related significantly to observed social reticence under the conditions of high parent-reported social inhibition, high teacher-reported social inhibition, and high SAD symptoms. These results suggest that the most inhibited children are aware of their behavior and can report it in a meaningfully way as young as kindergarten age. PMID:25113397

Mandatory quality reports in Germany from the hospitals’ point of view: a cross-sectional observational study

PubMed Central

2012-01-01

Background Public reporting of hospital quality is to enable providers, patients and the public to make comparisons regarding the quality of care and thus contribute to informed decisions. It stimulates quality improvement activities in hospitals and thus positively impacts treatment results. Hospitals often use publicly reported data for further internal or external purposes. As of 2005, German hospitals are obliged to publish structured quality reports (QR) every two years. This gives them the opportunity to demonstrate their performance by number, type and quality in a transparent way. However, it constitutes a major burden to hospitals to generate and publish data required, and it is yet unknown if hospitals feel adequately represented and at the same time consider the effort appropriate. This study assesses hospital leaders’ judgement about the capability of QR to put legally defined aims effectively and efficiently into practice. It also explores the additional purposes hospitals use their QR for. Methods In a cross-sectional observational study, a representative random sample out of 2,064 German hospitals (N=748) was invited to assess QR via questionnaire; 333 hospitals participated. We recorded the suitability of QR for representing number, type and quality of services, the adequacy of cost and benefits (6-level Likert scales) and additional purposes QR are used for (free text question). For representation purposes, the net sample was weighted for hospital size and hospital ownership (direct standardization). Data was analyzed descriptively and using inferential statistics (chi-2 test) or for the purpose of generating hypotheses. Results German hospitals rated the QR as suitable to represent the number of services but less so for the type and quality of services. The cost-benefit ratio was seen as inadequate. There were no significant differences between hospitals of different size or ownership. Public hospitals additionally used their reports for mostly

Steroidal contraceptives and bone fractures in women: evidence from observational studies.

PubMed

Lopez, Laureen M; Chen, Mario; Mullins Long, Sarah; Curtis, Kathryn M; Helmerhorst, Frans M

2015-07-21

Age-related decline in bone mass increases the risk of skeletal fractures, especially those of the hip, spine, and wrist. Steroidal contraceptives have been associated with changes in bone mineral density in women. Whether such changes affect the risk of fractures later in life is unclear. Hormonal contraceptives are among the most effective and most widely-used contraceptives. Concern about fractures may limit the use of these effective contraceptives. Observational studies can collect data on premenopausal contraceptive use as well as fracture incidence later in life. We systematically reviewed the evidence from observational studies of hormonal contraceptive use for contraception and the risk of fracture in women. Through June 2015, we searched for observational studies. The databases included PubMed, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, EMBASE, CINAHL, and Web of Science. We also searched for recent clinical trials through ClinicalTrials.gov and the ICTRP. For other studies, we examined reference lists of relevant articles and wrote to investigators for additional reports. We included cohort and case-control studies of hormonal contraceptive use. Interventions included comparisons of a hormonal contraceptive with a non-hormonal contraceptive, no contraceptive, or another hormonal contraceptive. The primary outcome was the risk of fracture. Two authors independently extracted the data. One author entered the data into RevMan, and a second author verified accuracy. We examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale (NOS), developed for case-control and cohort studies. Sensitivity analysis included studies of moderate or high quality based on our assessment with the NOS.Given the need to control for confounding factors in observational studies, we used adjusted estimates from the models as reported by the authors. Where we did not have adjusted analyses, we calculated the odds ratio (OR

Peer Observation Reports and Student Evaluations of Teaching: Who Are the Experts?

ERIC Educational Resources Information Center

Ackerman, David; Gross, Barbara L.; Vigneron, Franck

2009-01-01

This study is an exploratory inquiry into the perceptions of university faculty regarding two forms of teaching evaluations, student evaluations of teaching (SET), and peer observation reports (POR). Which, if either, better assesses the quality of instruction? Who are the real experts in judging teaching quality: peers who are experts in their…

South Carolina Coastal Erosion Study, Data Report for Observations, October 2003 - April 2004

USGS Publications Warehouse

Sullivan, Charlene M.; Warner, John C.; Martini, Marinna A.; Voulgaris, George; Work, Paul; Haas, Kevin A.; Hanes, Daniel

2006-01-01

Oceanographic observations have been made at nine locations in Long Bay, South Carolina from October 2003 through April 2004. These sites are centered around a shore-oblique sand feature that is approximately 10 km long, 2 km wide, and in excess of 3 m thick. The observations were collected through a collaborative effort with the U.S. Geological Survey, the University of South Carolina, and Georgia Institute of Technology Savannah Campus as part of a larger study to understand the physical processes that control the transport of sediments in Long Bay.

Complications of local anaesthesia. An observational study.

PubMed

Brand, H S; Bekker, W; Baart, J A

2009-11-01

Local anaesthesia is increasingly used by dental hygienists. As little is known about the incidence of adverse effects during and after the administration of local anaesthetics, we evaluated side-effects associated with local anaesthesia. A prospective observational study was conducted using standard criteria among a group of 103 patients receiving mandibular block anaesthesia. Physical reactions like clenching fists (14.5%), moaning (12.6%) and turning pale (7.8%) were frequently observed. Patients (3.8%) showed a painful reaction because of needle contact with a nerve or the periosteum. Systemic complications were not observed. After the injection, 41.7% said they felt tense during the administration; 4.9% of the patients reported swallowing problems and 3.9% a tachycardia. These results suggest that administration of local anaesthesia has a small risk of adverse events. Complications, if they occur, seem minor and transient in nature.

An observational study: associations between nurse-reported hospital characteristics and estimated 30-day survival probabilities

PubMed Central

Tvedt, Christine; Sjetne, Ingeborg Strømseng; Helgeland, Jon; Bukholm, Geir

2014-01-01

Background There is a growing body of evidence for associations between the work environment and patient outcomes. A good work environment may maximise healthcare workers’ efforts to avoid failures and to facilitate quality care that is focused on patient safety. Several studies use nurse-reported quality measures, but it is uncertain whether these outcomes are correlated with clinical outcomes. The aim of this study was to determine the correlations between hospital-aggregated, nurse-assessed quality and safety, and estimated probabilities for 30-day survival in and out of hospital. Methods In a multicentre study involving almost all Norwegian hospitals with more than 85 beds (sample size=30, information about nurses’ perceptions of organisational characteristics were collected. Subscales from this survey were used to describe properties of the organisations: quality system, patient safety management, nurse–physician relationship, staffing adequacy, quality of nursing and patient safety. The average scores for these organisational characteristics were aggregated to hospital level, and merged with estimated probabilities for 30-day survival in and out of hospital (survival probabilities) from a national database. In this observational, ecological study, the relationships between the organisational characteristics (independent variables) and clinical outcomes (survival probabilities) were examined. Results Survival probabilities were correlated with nurse-assessed quality of nursing. Furthermore, the subjective perception of staffing adequacy was correlated with overall survival. Conclusions This study showed that perceived staffing adequacy and nurses’ assessments of quality of nursing were correlated with survival probabilities. It is suggested that the way nurses characterise the microsystems they belong to, also reflects the general performance of hospitals. PMID:24728887

Reported emissions of organic gases are not consistent with observations

PubMed Central

Henry, Ronald C.; Spiegelman, Clifford H.; Collins, John F.; Park, EunSug

1997-01-01

Regulatory agencies and photochemical models of ozone rely on self-reported industrial emission rates of organic gases. Incorrect self-reported emissions can severely impact on air quality models and regulatory decisions. We compared self-reported emissions of organic gases in Houston, Texas, to measurements at a receptor site near the Houston ship channel, a major petrochemical complex. We analyzed hourly observations of total nonmethane organic carbon and 54 hydrocarbon compounds from C-2 to C-9 for the period June through November, 1993. We were able to demonstrate severe inconsistencies between reported emissions and major sources as derived from the data using a multivariate receptor model. The composition and the location of the sources as deduced from the data are not consistent with the reported industrial emissions. On the other hand, our observationally based methods did correctly identify the location and composition of a relatively small nearby chemical plant. This paper provides strong empirical evidence that regulatory agencies and photochemical models are making predictions based on inaccurate industrial emissions. PMID:11038551

Children’s recalls from five dietary-reporting validation studies: Intrusions in correctly reported and misreported options in school breakfast reports

PubMed Central

Baxter, Suzanne Domel; Hardin, James W.; Royer, Julie A.; Guinn, Caroline H.; Smith, Albert F.

2008-01-01

For school breakfast each day, many elementary schools offer a choice between a cold option that includes ready-to-eat (RTE) cereal and a hot option that includes a non-RTE-cereal entrée such as waffles. For breakfast reports, intrusions (reports of uneaten items) in correctly reported and misreported breakfast options were examined using data from five dietary-reporting validation studies. In each study, fourth-grade children were observed eating school breakfast and school lunch and then interviewed to obtain a dietary recall. A breakfast option was correctly reported in 240 breakfast reports for 203 intrusions total, and misreported in 97 breakfast reports for 189 intrusions total. Asymmetry was evident in misreported options; specifically, children observed eating a cold option almost never misreported a hot option, but children observed eating a hot option often misreported a cold option. Proportionately more breakfast reports were intrusion-free when a breakfast option was correctly reported than misreported. Linking of intrusions (i.e., multiple intrusions from the same option in a breakfast report) was especially evident with misreported breakfast options. Methodological aspects of dietary recalls such as target period (prior 24 hours; previous day), interview time (morning; afternoon; evening), and interview format (meal; open) had implications for intrusions and misreported breakfast options. PMID:18501992

Association between carbohydrate quality and inflammatory markers: systematic review of observational and interventional studies.

PubMed

Buyken, Anette E; Goletzke, Janina; Joslowski, Gesa; Felbick, Anna; Cheng, Guo; Herder, Christian; Brand-Miller, Jennie C

2014-04-01

Chronic low-grade inflammation is a likely intermediary between quality of carbohydrate and chronic disease risk. We conducted a systematic literature search to evaluate the relevance of carbohydrate quality on inflammatory markers in observational and intervention studies. MEDLINE, EMBASE, and the Cochrane Library were searched for studies on associations between glycemic index (GI), glycemic load (GL), dietary fiber or fiber supplements or whole grain intake, and high-sensitivity C-reactive protein (hsCRP) or interleukin 6 (IL-6). Included studies had to be conducted on adults (healthy, overweight, with type 2 diabetes or metabolic syndrome features, but without inflammatory disease) with ≥20 participants and a 3-wk duration. In total, 22 of the 60 studies that met our inclusion criteria examined GI/GL: 5 of 9 observational studies reported lower concentrations of hsCRP or IL-6 among persons with a lower dietary GI/GL; 3 of 13 intervention studies showed significant antiinflammatory effects of a low-GI/GL diet, and 4 further studies suggested beneficial effects (trends or effects in a subgroup). For fiber intake, 13 of 16 observational studies reported an inverse relation with hsCRP or IL-6, but only 1 of 11 intervention studies showed a significant antiinflammatory effect of fiber intake, and a further trial reported a beneficial trend. For whole-grain intake, 6 of 7 observational studies observed an inverse association with inflammatory markers, but only 1 of 7 intervention studies reported significant antiinflammatory effects, 1 further study was suggestive (in a subgroup) of such, and another study found an adverse effect (trend only). Evidence from intervention studies for antiinflammatory benefits is less consistent for higher-fiber or whole-grain diets than for low-GI/GL diets. Benefits of higher fiber and whole-grain intakes suggested by observational studies may reflect confounding.

Observed and Reported Supportive Coparenting as Predictors of Infant-Mother and Infant-Father Attachment Security

ERIC Educational Resources Information Center

Brown, Geoffrey L.; Schoppe-Sullivan, Sarah J.; Mangelsdorf, Sarah C.; Neff, Cynthia

2010-01-01

This study examined associations between supportive coparenting and infant-mother and infant-father attachment security. Observed and parent-reported coparenting, and observed maternal and paternal sensitivity were assessed in a sample of 68 families with 3.5-month-old infants. Infant-mother and infant-father attachment security were assessed in…

Observational Park-based Physical Activity Studies: A Systematic Review of the Literature

PubMed Central

Joseph, Rodney P.; Maddock, Jay E.

2016-01-01

This article reports the outcomes of a systematic review of observational park-based physical activity (PA) studies. Five electronic databases and the Active Living Research website were searched in July 2015 to identify relevant articles. Studies were included if they: a) reported observational data collected at outdoor park-based settings during free living conditions, b) reported results of a park audit, c) included PA as an outcome measure of the park audit, and d) were published after 1990 in English-language peer-review journals. Thirty-two articles, reporting outcomes of 26 unique studies, met inclusion criteria for review. Most studies (n=20, 87%) had cross-sectional or non-interventional study designs, while 6 (23%) employed quasi-experimental designs. Studies were predominately conducted in the U.S. (n=19, 76%). The median number of park users across studies was 4,558 (Range= 815 to 76,632). Approximately half (51%) of all park users were female. Eighty-one percent of studies (n=21) reported PA outcomes for individuals of all ages, while 4 studies (15%) reported PA outcomes for children only and 1 study (4%) for adults only. Moderate-to-vigorous physical activity (MVPA) of park users ranged from 31% to 85% (Median=55.0%). Studies conducted in the U.S. reported a slightly higher median number of park-users engaging in MVPA than those outside the U.S. (60.5% vs. 52.8%). Fifteen studies examined gender differences in MVPA. Among these, 12 (87%) reported more males engaging in MVPA than females. Results of this review highlight the need for innovative strategies to promote MVPA among park users and to increase park use among children. PMID:27311337

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

PubMed

Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

2014-04-01

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

Associations between informant ratings of personality disorder traits, self-reports of personality, and directly observed behavior.

PubMed

Kaurin, Aleksandra; Sauerberger, Kyle S; Funder, David C

2018-03-02

Diagnoses of personality disorders (PD) must rely on judgments of observers-either clinicians or acquaintances-because personality disorders are primarily defined in terms of maladaptive interpersonal behavior. Little is known, however, about how closely acquaintances' judgments of PD traits relate to self-reports of theoretically relevant Big Five traits or directly observed behavioral outcomes in interpersonal situations. The present study examines associations between judgments of the 10 PD traits provided by close acquaintances, self-reports of PD-relevant Big Five personality traits, and observed interpersonal behaviors across three different three-person laboratory interactions (i.e., unstructured chat, cooperative task, competitive game). The sample consisted of 256 undergraduate students (130 females; M age  = 19.83, SD = 1.25). Four unacquainted observers independently rated participants' behaviors from video recordings. In line with previous work, informant reports of PD traits demonstrate strong convergent validity with relevant self-reported Big Five traits (as identified by Lynam & Widiger, 2001). Directly observed behavior is meaningfully associated with acquaintances' judgments and self-reports of PD-relevant traits, and the associations between these judgments and behavior are strongest for traits associated with histrionic and schizoid PD. Vector correlations between behavioral profiles associated with informant and self-reports show that both assessments have similar behavioral correlates. Associations between PD trait ratings and behavior appeared to differ as a function of gender, with males showing more and stronger correlations. Informants' ratings of PD traits are impressively accurate, converging both with self-reports of relevant traits and directly observed interpersonal behavior. Therefore, a comprehensive understanding of PDs and associated traits can be augmented by information from multiple acquaintances who have the

A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients.

PubMed

Tijssen, Marsha; van Cingel, Robert; de Visser, Enrico; Nijhuis-van der Sanden, Maria

2016-07-01

To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. Observational cohort study. Sports medical center. 37 recreational athletes (21 men) at least six months after finishing rehabilitation for hip arthroscopy. International Hip Outcome Tool 33 (IHOT-33), Pain Visual Analogue Scale (VAS), Global Perceived Effect Scale (GPE), sports questionnaires and hip functional performance tests. At a mean follow-up time of 2.3 years, 81% of participants reported improvement on the GPE and 84% returned to sports activities. The mean IHOT-33 score was 69.3; the mean VAS score was 35.0. Range of motion (ROM) and strength were within the 90% Limb Symmetry Index (LSI) limit, except for hip internal rotation ROM. A full recovery of hip functional performance, as measured with balance and hop tests, was established based on the 90% LSI limit. The overall short- and midterm results of these follow-up data show good recovery of hip arthroscopy patients on patient-reported outcomes, functional performance and return to sports activities. The functional performance tests used in this study seem adequate for measuring recovery in hip arthroscopy patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Comparison of self-reported and observed prevalence of safety belt and helmet use in Florence.

PubMed

Lorini, C; Pieralli, F; Mersi, A; Cecconi, R; Garofalo, G; Santini, M G; Bonaccorsi, G

2014-01-01

Safety belt and helmet use was estimated from PASSI data and measured through Ulisse observations. Between 2008 and 2012 a total of 2,081 cars and motorcycle users were interviewed in the LHU of Florence and a total of 59,787 drivers (11,870 front passengers, 1,129 rear passengers and 16,816 motorcyclists) were observed. The comparison between self-reported and observed prevalences was performed by calculating the over-reporting factor (ORF), defined as the ratio of the self-reported to the observed prevalence of seat belt or helmet use. The time trend of the prevalence (both from self-reported and observed data) and of the ORF was assessed by using linear regression and Poisson's regression, respectively. The correlation between self-reported and observed prevalence is high, with a Pearson's correlation coefficient of 0.95 (p <0.05). Regarding front seat belt use rates, the difference between self-reported and observed data increases over time and the ORF range varies from 1.12 to 1.32. Rear seat belt data show a great variability, and the ORF varies from 0.67 to 1.37. In 2011 and 2012, the observed prevalence was higher than the self-reported one (ORF <1). Helmet use rates are very high, close to 100% with both methods; ORF has very small oscillations and ranges from 0.98 to 1, showing a good correlation between self-reported and observational data. There are no significant temporal variations both for the prevalences of use and for the ORF. The reasonable accuracy of self-reported data makes this method fit in the routinary assessment of safety belts and helmet usage, in order to limit the observations of the Ulisse system at predetermined time intervals. However, self-reported estimates need to be adjusted using an appropriate over-reporting factor.

Observational Park-based physical activity studies: A systematic review of the literature.

PubMed

Joseph, Rodney P; Maddock, Jay E

2016-08-01

This article reports the outcomes of a systematic review of observational park-based physical activity (PA) studies. Five electronic databases and the Active Living Research website were searched in July 2015 to identify relevant articles. Studies were included if they: a) reported observational data collected at outdoor park-based settings during free living conditions, b) reported results of a park audit, c) included PA as an outcome measure of the park audit, and d) were published after 1990 in English-language peer-review journals. Thirty-two articles, reporting outcomes of 26 unique studies, met inclusion criteria for review. Most studies (n=20, 87%) had cross-sectional or non-interventional study designs, while 6 (23%) employed quasi-experimental designs. Studies were predominately conducted in the U.S. (n=19, 76%). The median number of park users across studies was 4558 (Range=815 to 76,632). Approximately half (51%) of all park users were female. Eighty-one percent of studies (n=21) reported PA outcomes for individuals of all ages, while 4 studies (15%) reported PA outcomes for children only and 1 study (4%) for adults only. Moderate-to-vigorous physical activity (MVPA) of park users ranged from 31% to 85% (Median=55.0%). Studies conducted in the U.S. reported a slightly higher median number of park-users engaging in MVPA than those outside the U.S. (60.5% vs. 52.8%). Fifteen studies examined gender differences in MVPA. Among these, 12 (87%) reported more males engaging in MVPA than females. Results of this review highlight the need for innovative strategies to promote MVPA among park users and to increase park use among children. Copyright © 2016 Elsevier Inc. All rights reserved.

Parent and Adolescent Reports of Parenting When a Parent Has a History of Depression: Associations with Observations of Parenting

PubMed Central

Parent, Justin; Forehand, Rex; Dunbar, Jennifer P.; Watson, Kelly H.; Reising, Michelle M.; Seehuus, Martin; Compas, Bruce E.

2013-01-01

The current study examined the congruence of parent and adolescent reports of positive and negative parenting with observations of parent-adolescent interactions as the criterion measure. The role of parent and adolescent depressive symptoms in moderating the associations between adolescent or parent report and observations of parenting also was examined. Participants were 180 parents (88.9% female) with a history of clinical depression and one of their 9-to-15 year old children (49.4% female). Parents and adolescents reported on parenting skills and depressive symptoms, and parenting was independently observed subsequently in the same session. Findings indicated adolescent report of positive, but not negative, parenting was more congruent with observations than parent report. For negative parenting, depressive symptoms qualified the relation between the parent or adolescent report and independent observations. For parents, higher levels of depressive symptoms were associated with more congruence with observed parenting (supporting a depressive realism hypothesis) whereas an opposite trend emerged for adolescents (providing some supporting evidence for a depression-distortion hypothesis). PMID:23851629

Final Report for Geometric Observers and Particle Filtering for Controlled Active Vision

DTIC Science & Technology

2016-12-15

code) 15-12-2016 Final Report 01Sep06 - 09May11 Final Report for Geometric Observers & Particle Filtering for Controlled Active Vision 49414-NS.1Allen...Observers and Particle Filtering for Controlled Active Vision by Allen R. Tannenbaum School of Electrical and Computer Engineering Georgia Institute of...7 2.2.4 Conformal Area Minimizing Flows . . . . . . . . . . . . . . . . . . . . . . . 8 2.3 Particle Filters

Influenza newspaper reports and the influenza epidemic: an observational study in Fukuoka City, Japan.

PubMed

Hagihara, Akihito; Onozuka, Daisuke; Miyazaki, Shougo; Abe, Takeru

2015-12-30

We examined whether the weekly number of newspaper articles reporting on influenza was related to the incidence of influenza in a large city. Prospective, non-randomised, observational study. Registry data of influenza cases in Fukuoka City, Japan. A total of 83,613 cases of influenza cases that occurred between October 1999 and March 2007 in Fukuoka City, Japan. A linear model with autoregressive time series errors was fitted to time series data on the incidence of influenza and the accumulated number of influenza-related newspaper articles with different time lags in Fukuoka City, Japan. In order to obtain further evidence that the number of newspaper articles a week with specific time lags is related to the incidence of influenza, Granger causality was also tested. Of the 16 models including 'number of newspaper articles' with different time lags between 2 and 17 weeks (xt-2 to t-17), the β coefficients of 'number of newspaper articles' at time lags between t-5 and t-13 were significant. However, the β coefficients of 'number of newspaper articles' that are significant with respect to the Granger causality tests (p<0.05) were the weekly number of newspaper articles at time lags between t-6 and t-10 (time shift of 10 weeks, β=-0.301, p<0.01; time shift of 9 weeks, β=-0.200, p<0.01; time shift of 8 weeks, β=-0.156, p<0.01; time shift of 7 weeks, β=-0.122, p<0.05; time shift of 6 weeks, β=-0.113, p<0.05). We found that the number of newspaper articles reporting on influenza in a week was related to the incidence of influenza 6-10 weeks after media coverage in a large city in Japan. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Influenza newspaper reports and the influenza epidemic: an observational study in Fukuoka City, Japan

PubMed Central

Hagihara, Akihito; Onozuka, Daisuke; Miyazaki, Shougo; Abe, Takeru

2015-01-01

Objectives We examined whether the weekly number of newspaper articles reporting on influenza was related to the incidence of influenza in a large city. Design Prospective, non-randomised, observational study. Setting Registry data of influenza cases in Fukuoka City, Japan. Participants A total of 83 613 cases of influenza cases that occurred between October 1999 and March 2007 in Fukuoka City, Japan. Main outcome measure A linear model with autoregressive time series errors was fitted to time series data on the incidence of influenza and the accumulated number of influenza-related newspaper articles with different time lags in Fukuoka City, Japan. In order to obtain further evidence that the number of newspaper articles a week with specific time lags is related to the incidence of influenza, Granger causality was also tested. Results Of the 16 models including ‘number of newspaper articles’ with different time lags between 2 and 17 weeks (xt-2 to t-17), the β coefficients of ‘number of newspaper articles’ at time lags between t-5 and t-13 were significant. However, the β coefficients of ‘number of newspaper articles’ that are significant with respect to the Granger causality tests (p<0.05) were the weekly number of newspaper articles at time lags between t-6 and t-10 (time shift of 10 weeks, β=−0.301, p<0.01; time shift of 9 weeks, β=−0.200, p<0.01; time shift of 8 weeks, β=−0.156, p<0.01; time shift of 7 weeks, β=−0.122, p<0.05; time shift of 6 weeks, β=−0.113, p<0.05). Conclusions We found that the number of newspaper articles reporting on influenza in a week was related to the incidence of influenza 6–10 weeks after media coverage in a large city in Japan. PMID:26719323

Observational study to characterise 24-hour COPD symptoms and their relationship with patient-reported outcomes: results from the ASSESS study.

PubMed

Miravitlles, Marc; Worth, Heinrich; Soler Cataluña, Juan José; Price, David; De Benedetto, Fernando; Roche, Nicolas; Godtfredsen, Nina Skavlan; van der Molen, Thys; Löfdahl, Claes-Göran; Padullés, Laura; Ribera, Anna

2014-10-21

Few studies have investigated the 24-hour symptom profile in patients with COPD or how symptoms during the 24-hour day are inter-related. This observational study assessed the prevalence, severity and relationship between night-time, early morning and daytime COPD symptoms and explored the relationship between 24-hour symptoms and other patient-reported outcomes. The study enrolled patients with stable COPD in clinical practice. Baseline night-time, early morning and daytime symptoms (symptom questionnaire), severity of airflow obstruction (FEV1), dyspnoea (modified Medical Research Council Dyspnoea Scale), health status (COPD Assessment Test), anxiety and depression levels (Hospital Anxiety and Depression Scale), sleep quality (COPD and Asthma Sleep Impact Scale) and physical activity level (sedentary, moderately active or active) were recorded. The full analysis set included 727 patients: 65.8% male, mean ± standard deviation age 67.2 ± 8.8 years, % predicted FEV1 52.8 ± 20.5%. In each part of the 24-hour day, >60% of patients reported experiencing ≥1 symptom in the week before baseline. Symptoms were more common in the early morning and daytime versus night-time (81.4%, 82.7% and 63.0%, respectively). Symptom severity was comparable for each period assessed. Overall, in the week before baseline, 56.7% of patients had symptoms throughout the whole 24-hour day (3 parts of the day); 79.9% had symptoms in ≥2 parts of the 24-hour day. Symptoms during each part of the day were inter-related, irrespective of disease severity (all p < 0.001). Early morning and daytime symptoms were associated with the severity of airflow obstruction (p < 0.05 for both). Night-time, early morning and daytime symptoms were all associated with worse dyspnoea, health status and sleep quality, and higher anxiety and depression levels (all p < 0.001 versus patients without symptoms in each corresponding period). In each part of the 24-hour day, there was also an association between

A comparison of observed and self-reported helmet use and associated factors among motorcyclists in Hyderabad city, India.

PubMed

Wadhwaniya, S; Gupta, S; Mitra, S; Tetali, S; Josyula, L K; Gururaj, G; Hyder, A A

2017-03-01

India has a high burden of fatal road traffic injuries (RTIs). A large proportion of fatal RTIs in India are among motorcyclists. The overall goal of this study is to assess and compare observed and self-reported prevalence of helmet use; and to identify factors associated with helmet use and over-reporting in Hyderabad city, India. Roadside knowledge, attitude and practice interviews. Six rounds of roadside interviews were conducted with motorcyclists (drivers and pillion riders) between July 2011 and August 2013 using a structured tool developed for this study. Observations on helmet use were recorded and respondents were also asked if they 'always wear a helmet'. Prevalence of helmet use was calculated and a paired t-test was used to compare observed and self-reported helmet use proportions. Unadjusted and adjusted odds ratios were calculated to identify factors associated with helmet use and over-reporting. A total of 4872 respondents participated in the roadside interview. The response rate was 94.4%. The overall observed helmet use was 34.5% and 44.5% of respondents reported that they 'always wear a helmet'. As the observed helmet use increased, the over-reporting of helmet use was found to decrease. However, factors associated with observed and self-reported helmet use are similar. Male gender, youth (≤24 years), a lower level of education and non-ownership of helmet were associated with a higher risk of not wearing helmets. Male gender, youth (≤24 years), no schooling, riding a lower engine capacity motorcycle and using a motorcycle for purposes other than travelling to school/work were associated with over-reporting of helmet use. Self-reports provide an overestimate of helmet use that lessens as actual helmet use increases. Interviews also allow identification of factors associated with helmet use. Increasing helmet ownership and enhanced enforcement may help increase helmet use. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights

Settlement study : final report.

DOT National Transportation Integrated Search

1982-09-01

This report covers field observations of several medium and high embankments' settlement along Interstate Highways 12 and 20. The predictive settlements from laboratory tests (consolidation tests) are given in an interim report published in July, 198...

Parental behaviour in paediatric chronic pain: a qualitative observational study.

PubMed

Dunford, Emma; Thompson, Miles; Gauntlett-Gilbert, Jeremy

2014-10-01

Parental behaviour appears to influence the adjustment of children with chronic pain. However, research in this area has failed to produce consistent evidence. Studies have tended to rely on self-report measures derived from adult pain populations. This qualitative, observational research provides descriptive data of parental behaviour in a clinical environment. A qualitative observational study was made of parents and adolescents in a physically stressful setting. Modified grounded theory was used to analyse verbal and non-verbal behaviours. Eight parent-adolescent dyads seeking treatment for chronic pain were videoed during physical exercise sessions. Verbal and non-verbal behaviours were recorded and transcribed. Four overarching categories emerged: 'monitoring', 'protecting', 'encouraging' and 'instructing'. These often had both verbal and non-verbal aspects. Within these categories, more precise behavioural groups were also identified. This research identifies categories of parental behaviour that were derived directly from observation, rather than imposed on the basis of results from different populations. Four categories of behaviour were derived, which clarify and extend dimensions used in existing self-report instruments. Careful description of parental behaviours showed features that past research has neglected, and highlighted potential drawbacks of apparently positive parental actions. © The Author(s) 2013.

Bullying Predicts Reported Dating Violence and Observed Qualities in Adolescent Dating Relationships.

PubMed

Ellis, Wendy E; Wolfe, David A

2015-10-01

The relationship between reported bullying, reported dating violence, and dating relationship quality measured through couple observations was examined. Given past research demonstrating similarity between peer and dating contexts, we expected that bullying would predict negative dating experiences. Participants with dating experience (n = 585; 238 males, M(age) = 15.06) completed self-report assessments of bullying and dating violence perpetration and victimization. One month later, 44 opposite-sex dyads (M(age) = 15.19) participated in behavioral observations. In 10-min sessions, couples were asked to rank and discuss areas of relationship conflict while being video-recorded. Qualities of the relationship were later coded by trained observers. Regression analysis revealed that bullying positively predicted dating violence perpetration and victimization. Self-reported bullying also predicted observations of lower relationship support and higher withdrawal. Age and gender interactions further qualified these findings. The bullying of boys, but not girls, was significantly related to dating violence perpetration. Age interactions showed that bullying was positively predictive of dating violence perpetration and victimization for older, but not younger adolescents. Positive affect was also negatively predicted by bullying, but only for girls. These findings add to the growing body of evidence that adolescents carry forward strategies learned in the peer context to their dating relationships. © The Author(s) 2014.

Carolinas Coastal Change Processes Project data report for nearshore observations at Cape Hatteras, North Carolina

USGS Publications Warehouse

Armstrong, Brandy N.; Warner, John C.; Voulgaris, George; List, Jeffrey H.; Thieler, Robert; Martini, Marinna A.; Montgomery, Ellyn T.; McNinch, Jesse E.; Book, Jeffrey W.; Haas, Kevin

2013-01-01

An oceanographic field study conducted in February 2010 investigated processes that control nearshore flow and sediment transport dynamics at Cape Hatteras, North Carolina. This report describes the project background, field program, instrumentation setup, and locations of the sensor deployments. The data collected, and supporting meteorological and streamflow observations, are presented as time-series plots for data visualization. Additionally, the data are available as part of this report.

Report on the ALPO LTP observing program. [for establishing albedo scale for lunar features

NASA Technical Reports Server (NTRS)

Cameron, W. S.

1974-01-01

Observations of lunar transient phenomena for the Association of Lunar and Planetary Observers (ALPO) are reported. The procedures for making visual observations for estimating albedo are described, and the reported albedo analyzed for lunar topographic features. It is shown that a catalog or scale of albedos can be established for each feature.

STRengthening Analytical Thinking for Observational Studies: the STRATOS initiative

PubMed Central

Sauerbrei, Willi; Abrahamowicz, Michal; Altman, Douglas G; le Cessie, Saskia; Carpenter, James

2014-01-01

The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even ‘standard’ analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests. In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved. PMID:25074480

STRengthening analytical thinking for observational studies: the STRATOS initiative.

PubMed

Sauerbrei, Willi; Abrahamowicz, Michal; Altman, Douglas G; le Cessie, Saskia; Carpenter, James

2014-12-30

The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even 'standard' analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests. In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved. © 2014 The Authors. Statistics in Medicine published by John Wiley & Sons, Ltd.

Space observations for global and regional studies of the biosphere

NASA Technical Reports Server (NTRS)

Cihlar, J.; Li, Z.; Chen, J.; Sellers, P.; Hall, F.

1994-01-01

The capability to make space-based measurements of Earth at high spatial and temporal resolutions, which would not otherwise be economically or practically feasible, became available just in time to contribute to scientific understanding of the interactive processes governing the total Earth system. Such understanding has now become essential in order to take practical steps which would counteract or mitigate the pervasive impact of the growing human population on the future habitability of the Earth. The paper reviews the rationale for using space observations for studies of climate and terrestrial ecosystems at global and regional scales, as well as the requirements for such observations for studies of climate and ecosystem dynamics. The present status of these developments is reported along with initiatives under way to advance the use of satellite observations for Earth system studies. The most important contribution of space observations is the provision of physical or biophysical parameters for models representing various components of the Earth system. Examples of such parameters are given for climatic and ecosystem studies.

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.

Use of portable ladders - field observations and self-reported safety performance in the cable TV industry.

PubMed

Chang, Wen-Ruey; Huang, Yueng-Hsiang; Brunette, Christopher; Lee, Jin

2017-11-01

Portable ladders incidents remain a major cause of falls from heights. This study reported field observations of environments, work conditions and safety behaviour involving portable ladders and their correlations with self-reported safety performance. Seventy-five professional installers of a company in the cable and other pay TV industry were observed for 320 ladder usages at their worksites. The participants also filled out a questionnaire to measure self-reported safety performance. Proper setup on slippery surfaces, correct method for ladder inclination setup and ladder secured at the bottom had the lowest compliance with best practices and training guidelines. The observation compliance score was found to have significant correlation with straight ladder inclined angle (Pearson's r = 0.23, p < 0.0002) and employees' self-reported safety participation (r = 0.29, p < 0.01). The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours. Practitioner Summary: A checklist was used while observing professional installers of a cable company for portable ladder usage at their worksites. Items that had the lowest compliance with best practices and training guidelines were identified. The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours.

The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.

PubMed

Chan, Yu-Feng Yvonne; Wang, Pei; Rogers, Linda; Tignor, Nicole; Zweig, Micol; Hershman, Steven G; Genes, Nicholas; Scott, Erick R; Krock, Eric; Badgeley, Marcus; Edgar, Ron; Violante, Samantha; Wright, Rosalind; Powell, Charles A; Dudley, Joel T; Schadt, Eric E

2017-04-01

The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.

The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit

PubMed Central

Chan, Yu-Feng Yvonne; Wang, Pei; Rogers, Linda; Tignor, Nicole; Zweig, Micol; Hershman, Steven G; Genes, Nicholas; Scott, Erick R; Krock, Eric; Badgeley, Marcus; Edgar, Ron; Violante, Samantha; Wright, Rosalind; Powell, Charles A; Dudley, Joel T; Schadt, Eric E

2017-01-01

The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care. PMID:28288104

Observer Rated Sleepiness and Real Road Driving: An Explorative Study

PubMed Central

Anund, Anna; Fors, Carina; Hallvig, David; Åkerstedt, Torbjörn; Kecklund, Göran

2013-01-01

The aim of the present study was to explore if observer rated sleepiness (ORS) is a feasible method for quantification of driver sleepiness in field studies. Two measures of ORS were used: (1) one for behavioural signs based on facial expression, body gestures and body movements labelled B-ORS, and (2) one based on driving performance e.g. if swerving and other indicators of impaired driving occurs, labelled D-ORS. A limited number of observers sitting in the back of an experimental vehicle on a motorway about 2 hours repeatedly 3 times per day (before lunch, after lunch, at night) observed 24 participant’s sleepiness level with help of the two observer scales. At the same time the participant reported subjective sleepiness (KSS), EOG was recorded (for calculation of blink duration) and several driving measure were taken and synchronized with the reporting. Based on mixed model Anova and correlation analysis the result showed that observer ratings of sleepiness based on drivers’ impaired performance and behavioural signs are sensitive to extend the general pattern of time awake, circadian phase and time of driving. The detailed analysis of the subjective sleepiness and ORS showed weak correspondence on an individual level. Only 16% of the changes in KSS were predicted by the observer. The correlation between the observer ratings based on performance (D-ORS) and behavioural signs (B-ORS) are high (r = .588), and the B-ORS shows a moderately strong association (r = .360) with blink duration. Both ORS measures show an association (r>0.45) with KSS, whereas the association with driving performance is weak. The results show that the ORS-method detects the expected general variations in sleepy driving in field studies, however, sudden changes in driver sleepiness on a detailed level as 5 minutes is usually not detected; this holds true both when taking into account driving behaviour or driver behavioural signs. PMID:23724094

UAS Reports (UREPs): EnablingExchange of Observation Data Between UAS Operations

NASA Technical Reports Server (NTRS)

Rios, Joseph; Smith, David; Smith, Irene

2017-01-01

As the volume of small unmanned aircraft systems (UAS) operations increases, the lack of weather products to support these operations becomes more problematic. One early solution to obtaining more information about weather conditions is to allow operators to share their observations and measurements with other airspace users. This is analogous to the AIREP and PIREP reporting systems in traditional aviation wherein pilots report weather phenomena they have observed or experienced to provide better situational awareness to other pilots. Given the automated nature of the small (under 55 lbs.) UAS platforms and operations, automated reporting of relevant information should also be supported. To promote automated exchange of these data, a well-defined data schema needs to be established along with the mechanisms for sending and retrieving the data. This paper examines this concept and offers an initial definition of the necessary elements to allow for immediate implementation and use.

Clinical research on postoperative trauma care: has the position of observational studies changed?

PubMed

Smeeing, D P J; Houwert, R M; Kruyt, M C; van der Meijden, O A J; Hietbrink, F

2017-02-01

The postoperative care regimes of ankle fractures are studied for over 30 years and recommendations have shifted only slightly in the last decades. However, study methodology might have evolved. The aim of this study was to evaluate the changes in time in the design, quality and outcome measures of studies investigating the postoperative care of ankle fractures. The MEDLINE and EMBASE database were searched for both RCTs and cohort studies. The original studies were divided into decades of publication over the last 30 years. The methodological quality of the studies was assessed using the 'traditional' risk of bias assessment tool provided by The Cochrane Collaboration and the 'newer' MINORS criteria. The percentage of RCTs on this subject declined from 67 to 38 % in the last decades. According to the Cochrane tool, the reported quality of RCTs has improved in the last three decades whereas the reported quality of observational studies has remained unchanged. However, when quality was evaluated with the MINORS criteria, equal improvement was observed for both RCTs and observational studies. In the 80s, 67 % of all studies used the range of motion as the primary outcome measure, which decreased to 45 % in the 90s. In the 00s, none of the studies used the range of motion as the primary outcome. For postoperative care of ankle fractures, results of this study showed a relative decrease in the published number of RCTs. The overall quality of the published articles did not decline. In addition, a gradual shift from physician measured to patient-reported outcome variables was observed. However, it should be borne in mind that the findings are based on a small sample (n = 25).

A likely source of an observation report in Ptolemy's Almagest.

NASA Astrophysics Data System (ADS)

Jones, A.

1999-09-01

A recently publishes volume of Greek papyri from Oxyrhynchus (modern Bahnasa, Egypt) containing astronomical text, tables, and horoscopes also includes a fragment of a theoretical work on planetary theory. This text, published under the number P.Oxy. LXI 4133, contains the report of an observation of Jupiter's position in AD 104-105 and refers also to another observation of Jupiter made 344 years earlier. The author of the present note has identified tentatively Menelaus of Alexandria as the author of the treatise on planetary theory. Here, he argues that the recovered treatise was very likely Ptolemy's immediate source for the Jupiter observations referred to in the Almagest.

Space Studies Board Annual Report 1995

NASA Technical Reports Server (NTRS)

1996-01-01

During 1995, the Space Studies Board and its committees and task groups gathered for a total of 40 meetings. Highlights of these meetings are presented. Formal study reports and short reports developed and approved during the meetings and issued during 1995 are represented in this annual report either by their executive summaries (for full-length reports), or by reproduction in full (for short reports). Nine full-length reports were distributed or delivered, including a congressionally mandated report by the Committee on the Future of Space Science and a comprehensive survey of Earth observation programs by the Committee on Earth Studies. Major research guidance reports were completed and published by the Committee on Microgravity Research and by the federated Committee on Solar and Space Physics/Committee on Solar-Terrestrial Research. Several significant assessment reports were also published, including an assessment of small missions by the Committee on Planetary and Lunar Exploration, a scientific evaluation of Gravity Probe B by the Task Group on Gravity Probe B, and an analysis of technologies for a 4-meter active optics telescope by the Task Group on BMDO New Technology Orbital Observatory. In addition, the Committee on Astronomy and Astrophysics Panel on Ground-based Optical and Infrared Astronomy released its report, and the Task Group on Priorities in Space Research issued its second and final report. Five short reports were also prepared and released during 1995. They addressed such diverse topics as reflight of shuttle-borne synthetic aperture radars, the role of NASA centers and center scientists in scientific research, guidelines for establishment of NASA research institutes, and clarification of findings of the microgravity research opportunities report and of the Future of Space Science Committee's management study.

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

PubMed

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

2016-07-01

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

Comparing the predictive capacity of observed in-session resistance to self-reported motivation in cognitive behavioral therapy.

PubMed

Westra, Henny A

2011-02-01

Self-report measures of motivation for changing anxiety have been weakly and inconsistently related to outcome in cognitive behavioral therapy (CBT). While clients may not be able to accurately report their motivation, ambivalence about change may nonetheless be expressed in actual therapy sessions as opposition to the direction set by the therapist (i.e., resistance). In the context of CBT for generalized anxiety disorder, the present study compared the ability of observed in-session resistance in CBT session 1 and two self-report measures of motivation for changing anxiety (the Change Questionnaire & the Client Motivational for Therapy Scale) to (1) predict client and therapist rated homework compliance (2) predict post-CBT and one-year post-treatment worry reduction, and (3) differentiate those who received motivational interviewing prior to CBT from those who received no pre-treatment. Observed in-session resistance performed very well on each index, compared to the performance of self-reported motivation which was inconsistent and weaker relative to observed resistance. These findings strongly support both clinician sensitivity to moments of client resistance in actual therapy sessions as early as session 1, and the inclusion of observational process measures in CBT research. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Media Coverage, Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study.

PubMed

Wang, Michael T M; Bolland, Mark J; Gamble, Greg; Grey, Andrew

2015-01-01

Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported 'hard' outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting 'hard' outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported 'hard' outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage.

Validation of Mode-S Meteorological Routine Air Report aircraft observations

NASA Astrophysics Data System (ADS)

Strajnar, B.

2012-12-01

The success of mesoscale data assimilation depends on the availability of three-dimensional observations with high spatial and temporal resolution. This paper describes an example of such observations, available through Mode-S air traffic control system composed of ground radar and transponders on board the aircraft. The meteorological information is provided by interrogation of a dedicated meteorological data register, called Meteorological Routine Air Report (MRAR). MRAR provides direct measurements of temperature and wind, but is only returned by a small fraction of aircraft. The quality of Mode-S MRAR data, collected at the Ljubljana Airport, Slovenia, is assessed by its comparison with AMDAR and high-resolution radiosonde data sets, which enable high- and low-level validation, respectively. The need for temporal smoothing of raw Mode-S MRAR data is also studied. The standard deviation of differences between smoothed Mode-S MRAR and AMDAR is 0.35°C for temperature, 0.8 m/s for wind speed and below 10 degrees for wind direction. The differences with respect to radiosondes are larger, with standard deviations of approximately 1.7°C, 3 m/s and 25 degrees for temperature, wind speed and wind direction, respectively. It is concluded that both wind and temperature observations from Mode-S MRAR are accurate and therefore potentially very useful for data assimilation in numerical weather prediction models.

Relationships of multitasking, physicians' strain, and performance: an observational study in ward physicians.

PubMed

Weigl, Matthias; Müller, Andreas; Sevdalis, Nick; Angerer, Peter

2013-03-01

Simultaneous task performance ("multitasking") is common in hospital physicians' work and is implicated as a major determinant for enhanced strain and detrimental performance. The aim was to determine the impact of multitasking by hospital physicians on their self reported strain and performance. A prospective observational time-and-motion study in a Community Hospital was conducted. Twenty-seven hospital physicians (surgical and internal specialties) were observed in 40 full-shift observations. Observed physicians reported twice on their self-monitored strain and performance during the observation time. Associations of observed multitasking events and subsequent strain and performance appraisals were calculated. About 21% of the working time physicians were engaged in simultaneous activities. The average time spent in multitasking activities correlated significantly with subsequently reported strain (r = 0.27, P = 0.018). The number of instances of multitasking activities correlated with self-monitored performance to a marginally significant level (r = 0.19, P = 0.098). Physicians who engage in multitasking activities tend to self-report better performance but at the cost of enhanced psychophysical strain. Hence, physicians do not perceive their own multitasking activities as a source for deficient performance, for example, medical errors. Readjustment of workload, improved organization of work for hospital physicians, and training programs to improve physicians' skills in dealing with multiple clinical demands, prioritization, and efficient task allocation may be useful avenues to explore to reduce the potentially negative impact of simultaneous task performance in clinical settings.

Parent-Child Mathematical Interactions: Examining Self-Report and Direct Observation

ERIC Educational Resources Information Center

Missall, Kristen N.; Hojnoski, Robin L.; Moreano, Ginna

2017-01-01

Variability in children's early-learning home environments points to the need to better understand specific mechanisms of early mathematical development. We used a sample of 66 parent-preschool child dyads to describe parent-reported mathematical activities in the home and observed parent-child mathematical activities in a semi-structured play…

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

Using non-specialist observers in 4AFC human observer studies

NASA Astrophysics Data System (ADS)

Elangovan, Premkumar; Mackenzie, Alistair; Dance, David R.; Young, Kenneth C.; Wells, Kevin

2017-03-01

Virtual clinical trials (VCTs) are an emergent approach for rapid evaluation and comparison of various breast imaging technologies and techniques using computer-based modeling tools. Increasingly 4AFC (Four alternative forced choice) virtual clinical trials are used to compare detection performances of different breast imaging modalities. Most prior studies have used physicists and/or radiologists and physicists interchangeably. However, large scale use of statistically significant 4AFC observer studies is challenged by the individual time commitment and cost of such observers, often drawn from a limited local pool of specialists. This work aims to investigate whether non-specialist observers can be used to supplement such studies. A team of five specialist observers (medical physicists) and five non-specialists participated in a 4AFC study containing simulated 2D-mammography and DBT (digital breast tomosynthesis) images, produced using the OPTIMAM toolbox for VCTs. The images contained 4mm irregular solid masses and 4mm spherical targets at a range of contrast levels embedded in a realistic breast phantom background. There was no statistically significant difference between the detection performance of medical physicists and non-specialists (p>0.05). However, non-specialists took longer to complete the study than their physicist counterparts, which was statistically significant (p<0.05). Overall, the results from both observer groups indicate that DBT has a lower detectable threshold contrast than 2D-mammography for both masses and spheres, and both groups found spheres easier to detect than irregular solid masses.

Media Coverage, Journal Press Releases and Editorials Associated with Randomized and Observational Studies in High-Impact Medical Journals: A Cohort Study

PubMed Central

Wang, Michael T. M.; Bolland, Mark J.; Gamble, Greg; Grey, Andrew

2015-01-01

Background Publication of clinical research findings in prominent journals influences health beliefs and medical practice, in part by engendering news coverage. Randomized controlled trials (RCTs) should be most influential in guiding clinical practice. We determined whether study design of clinical research published in high-impact journals influences media coverage. Methods and Findings We compared the incidence and amount of media coverage of RCTs with that of observational studies published in the top 7 medical journals between 1 January 2013 and 31 March 2013. We specifically assessed media coverage of the most rigorous RCTs, those with >1000 participants that reported ‘hard’ outcomes. There was no difference between RCTs and observational studies in coverage by major newspapers or news agencies, or in total number of news stories generated (all P>0.63). Large RCTs reporting ‘hard’ outcomes did not generate more news coverage than small RCTs that reported surrogate outcomes and observational studies (all P>0.32). RCTs were more likely than observational studies to attract a journal editorial (70% vs 46%, P = 0.003), but less likely to be the subject of a journal press release (17% vs 50%, P<0.001). Large RCTs that reported ‘hard’ outcomes did not attract an editorial more frequently than other studies (61% vs 58%, P>0.99), nor were they more likely to be the subject of a journal press release (14% vs 38%, P = 0.14). Conclusions The design of clinical studies whose results are published in high-impact medical journals is not associated with the likelihood or amount of ensuing news coverage. PMID:26701758

Bovine thrombin safety reporting: an example of study design and publication bias.

PubMed

Crean, Sheila; Michels, Shannon L; Moschella, Kevin; Reynolds, Matthew W

2010-01-01

Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials. A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed. In 38 studies, about half were case reports and 31.5% were interventional trials. In case reports, 41% of authors reported severe coagulopathic adverse events. In contrast, whereas blood complications were common in large trials, no association of harm was established for bovine thrombin product exposure and/or immunization. In this review, later clinical trials failed to reproduce the common and severe coagulopathy predicted by earlier observational studies in bovine exposed patients. This example illustrates that perceptions of safety can change as a function of study design, even for a widely adopted, well established biologic such as thrombin. Caution must be exercised in interpreting evidence from observational studies alone.

Observing the Great Plains Low-Level Jet Using the Aircraft Communications Addressing and Reporting System (ACARS): A Comparison with Boundary Layer Profiler Observations

NASA Astrophysics Data System (ADS)

Skinner, P. S.; Basu, S.

2009-12-01

Wind resources derived from the nocturnal low-level jet of the Great Plains of the United States are a driving factor in the proliferation of wind energy facilities across the region. Accurate diagnosis and forecasting of the low-level jet is important to not only assess the wind resource but to estimate the potential for shear-induced stress generation on turbine rotors. This study will examine the utility of Aircraft Communications Addressing and Reporting System (ACARS) observations in diagnosing low-level jet events across the Texas Panhandle. ACARS observations from Lubbock International Airport (KLBB) will be compared to observations from a 915 MHZ Doppler radar vertical boundary-layer profiler with 60m vertical resolution located at the field experiment site of Texas Tech University. The ability of ACARS data to adequately observe low-level jet events during the spring and summer of 2009 will be assessed and presented.

Challenges in translating endpoints from trials to observational cohort studies in oncology

PubMed Central

Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

2016-01-01

Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting.

PubMed

Kabanywanyi, Abdunoor M; Mulure, Nathan; Migoha, Christopher; Malila, Aggrey; Lengeler, Christian; Schlienger, Raymond; Genton, Blaise

2010-07-14

To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania. Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008). Training was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Experience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing

Evaluating the Impact of Database Heterogeneity on Observational Study Results

PubMed Central

Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

2013-01-01

Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

Data Report of Hydrographic Observations: Geomagnetic Observations at the Hatizyo Hydrographic Observatory for the Year 1994. No. 12

NASA Technical Reports Server (NTRS)

1996-01-01

The Hatizyo Hydrographic Observatory, which is one of the essential magnetic observatories in Japan, was established in 1979 and is currently operated by the Hydrographic Department, Maritime Safety Agency. This is the annual report compiled from the results of magnetic observations carried out at the observatory in 1994. As to the instruments used for magnetic observations, the digital recording variometer was replaced by a fluxgate magnetometer in 1986, and one set each of the proton and fluxgate magnetometers was additionally installed in January and October 1992, respectively.

Data Report of Hydrographic Observations: Geomagnetic Observations at the Hatizyo Hydrographic Observatory for the Year 1993. No. 11

NASA Technical Reports Server (NTRS)

1995-01-01

The Hatizyo Hydrographic Observatory, which is one of the essential magnetic observatories in Japan, was established in 1979 and is currently operated by the Hydrographic Department, Maritime Safety Agency. This is the annual report compiled from the results of magnetic observations carried out at the observatory in 1993. As to the instruments used for magnetic observations, the digital recording variometer was replaced by a fluxgate magnetometer in 1986, and one set each of the proton and fluxgate magnetometers was additionally installed in January and October 1992, respectively.

[Quality analysis of observational studies on pelvic organ prolapse in China].

PubMed

Wang, Y T; Tao, L Y; He, H J; Han, J S

2017-06-25

Objective: To evaluate the quality of observational studies on pelvic organ prolapse in China. Methods: The checklist of strengthening the reporting of observational studies in epidemiology (STROBE) statement was applied to evaluate the observational studies. The articles were searched in the SinoMed database using the terms: prolapse, uterine prolapse, cystocele, rectal prolapse and pelvic floor; limited to Chinese core journals in obstetrics and gynecology from January 1996 to December 2015. With two 10-year groups (1996-2005 and 2006-2015), the χ(2) test was used to evaluate inter-group differences. Results: (1) A total of 386 observational studies were selected, including 15.5%(60/386) of case-control studies, 80.6%(311/386) of cohort studies and 3.9% (15/386) of cross-sectional studies. (2) There were totally 22 items including 34 sub-items in the checklist. There were 17 sub-items (50.0%, 17/34) had a reporting ratio less than 50% in all of aticles, including: 1a (study's design) 3.9% (15/386), 6a (participants) 24.6% (95/386), 6b (matched studies) 0 (0/386), 9 (bias) 8.3% (32/386), 10 (study size) 3.9%, 11 (quantitative variables) 41.2% (159/386), 12b-12e (statistical methods in detail) 0-2.6% (10/386), 13a (numbers of individuals at each stage of study) 18.9% (73/386), 13b (reasons for non-participation at each stage) 18.9%, 13c (flow diagram) 0, 16b and 16c (results of category boundaries and relative risk) 9.6% (37/386) and 0, 19 (limitations) 31.6% (122/386), 22 (funding) 20.5% (79/386). (3) The quality of articles published in the two decades (1996-2005 and 2006-2015) were compared, and 38.2%(13/34) of sub-items had been significantly improved in the second 10-year (all P< 0.05). The improved items were as follows: 1b (integrity of abstract), 2 (background/rationale), 6a (participants), 7 (variables), 8 (data sources/measurement), 9 (bias), 11 (quantitative variables), 12a (statistical methods), 17 (other analyses), 18 (key results), 19 (limitations

Assimilating Tropospheric Airborne Meteorological Data Reporting (TAMDAR) Observations and the Relative Value of Other Observation Types

DTIC Science & Technology

2014-08-01

Using real-time weather data from an unmanned aircraft system to support the advanced research version of the weather research and forecast model... system that is used to transmit some MDCRS observations, the Aircraft Communications Addressing and Reporting System (ACARS). A new network of aircraft ...Technical Analysis and Applications Center, and AirDat LLC developed a modified TAMDAR sensor referred to as TAMDAR- Unmanned Aerial System (TAMDAR-U) for

A theoretical and observational study of the Red Giant Branch phase transition in Magellanic Cloud clusters - A progress report

NASA Technical Reports Server (NTRS)

Buonanno, R.; Corsi, C. E.; Fusi Pecci, F.; Greggio, L.; Renzini, A.; Sweigart, A. V.

1986-01-01

Preliminary results are reported for an investigation comparing theoretical models of the sudden appearance of an extended RGB (and its effects on the spectral energy distributions of stellar populations) with data from ESO CCD observations of clusters in the LMC and SMC. Isochrones for the entire RGB are being constructed on the basis of 100 new evolutionary sequences (calculated using the evolution code of Sweigart and Gross, 1976 and 1978) to permit determination of synthetic colors and spectral energy distributions. The observations so far indicate a main sequence about 0.1 mag redder than that predicted by the present models or by the isochrones of VandenBerg and Bell (1985), and fail to show a B-V color difference at the RGB phase transition.

Do children report differently from their parents and from observed data? Cross-sectional data on fruit, water, sugar-sweetened beverages and break-time foods.

PubMed

van de Gaar, V M; Jansen, W; van der Kleij, M J J; Raat, H

2016-04-18

Reliable assessment of children's dietary behaviour is needed for research purposes. The aim of this study was (1) to investigate the level of agreement between observed and child-reported break-time food items; and (2) to investigate the level of agreement between children's reports and those of their parents regarding children's overall consumption of fruit, water and sugar-sweetened beverages (SSB). The children in this study were 9-13 years old, attending primary schools in Rotterdam, the Netherlands. Children were observed with respect to foods brought for break-time at school. At the same day, children completed a questionnaire in which they were asked to recall the food(s) they brought to school to consume during break-time. Only paired data (observed and child-reported) were included in the analyses (n = 407 pairs). To determine each child's daily consumption and average amounts of fruit, water and SSB consumed, children and their parents completed parallel questionnaires. Only paired data (parent-reported and child-reported) were included in the analyses (n = 275 pairs). The main statistical measures were level of agreement between break-time foods, fruit, water and SSB; and Intra-class Correlation Coefficients (ICC). More children reported bringing sandwiches and snacks for break-time than was observed (73 % vs 51 % observed and 84 % vs 33 % observed). The overall agreement between observed and child-reported break-time foods was poor to fair, with ICC range 0.16-0.39 (p < 0.05). Children reported higher average amounts of SSB consumed than did their parents (1.3 vs 0.9 L SSB, p < 0.001). Child and parent estimations of the child's water and fruit consumption were similar. ICC between parent and child reports was poor to good (range 0.22-0.62, p < 0.05). Children report higher on amount of break-time foods as compared to observations and children's reports of SSB consumption are higher than those of their parents. Since the level

Coastal Change Processes Project data report for observations near Fire Island, New York, January to April 2012

USGS Publications Warehouse

Armstrong, Brandy N.; Warner, John C.; List, Jeffrey H.; Martini, Marinna A.; Montgomery, Ellyn T.; Voulgaris, George; Traykovski, Peter A.

2015-01-01

An oceanographic field study during January through April 2012 investigated processes that control the sediment-transport dynamics near Fire Island, New York. This report describes the project background, field program, instrumentation configuration, and locations of the sensors deploymed. The data collected and supporting meteorological observations are presented as time series plots for data visualization. Additionally, individual, links to the database containing digital data files are available as part of this report.

Comparison of self-reported and observed water contact in an S. mansoni endemic village in Brazil.

PubMed

Friedman, J F; Kurtis, J D; McGarvey, S T; Fraga, A L; Silveira, A; Pizziolo, V; Gazzinelli, G; LoVerde, P; Corrêa-Oliveira, R

2001-03-30

Estimates of exposure are critical for immuno-epidemiologic and intervention studies in human schistosomiasis. Direct observation of human water contact patterns is both costly and time consuming. To address these issues, we determined whether individuals residing in a Schistosoma mansoni endemic village in Brazil could accurately self-report their water contact patterns. We compared the results of a water contact questionnaire to the present gold standard, direct observation of water contact in 86 volunteers, aged 8--29. We administered a survey to estimate volunteers' frequency and type of water contact and directly measured each volunteers' water contact patterns during 5 weeks of detailed water contact observations. We found a poor correlation between self reported frequency of contact and directly observed exposure (rho=0.119, P=NS). The questionnaire data was supplemented by information about average body surface area of exposure and duration of contact for specific activities derived from observations of this cohort. This 'supplemented questionnaire' data was significantly correlated with their exposure index (rho=0.227, P=0.05). It provides a starting point from which questionnaires may develop to provide a more cost-effective and less labor intensive method of assessing water contact exposure at the level of the individual.

Shift work and diabetes mellitus: a meta-analysis of observational studies.

PubMed

Gan, Yong; Yang, Chen; Tong, Xinyue; Sun, Huilian; Cong, Yingjie; Yin, Xiaoxu; Li, Liqing; Cao, Shiyi; Dong, Xiaoxin; Gong, Yanhong; Shi, Oumin; Deng, Jian; Bi, Huashan; Lu, Zuxun

2015-01-01

Observational studies suggest that shift work may be associated with diabetes mellitus (DM). However, the results are inconsistent. No systematic reviews have applied quantitative techniques to compute summary risk estimates. To conduct a meta-analysis of observational studies assessing the association between shift work and the risk of DM. Relevant studies were identified by a search of PubMed, Embase, Web of Science and ProQuest Dissertation and Theses databases to April 2014. We also reviewed reference lists from retrieved articles. We included observational studies that reported OR with 95% CIs for the association between shift work and the risk of DM. Two authors independently extracted data and assessed the study quality. Twelve studies with 28 independent reports involving 226 652 participants and 14 595 patients with DM were included. A pooled adjusted OR for the association between ever exposure to shift work and DM risk was 1.09 (95% CI 1.05 to 1.12; p=0.014; I(2)=40.9%). Subgroup analyses suggested a stronger association between shift work and DM for men (OR=1.37, 95% CI 1.20 to 1.56) than for women (OR=1.09, 95% CI 1.04 to 1.14) (p for interaction=0.01). All shift work schedules with the exception of mixed shifts and evening shifts were associated with a statistically higher risk of DM than normal daytime schedules, and the difference among those shift work schedules was significant (p for interaction=0.04). Shift work is associated with an increased risk of DM. The increase was significantly higher among men and the rotating shift group, which warrants further studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Reporting observational studies of the use of information technology in the clinical consultation. A position statement from the IMIA Primary Health Care Informatics Working Group (IMIA PCI WG).

PubMed

de Lusignan, S; Pearce, C; Kumarapeli, P; Stavropoulou, C; Kushniruk, A; Sheikh, A; Shachak, A; Mendis, K

2011-01-01

To develop a classification system to improve the reporting of observational studies of the use of information technology (IT) in clinical consultations. Literature review, workshops, and development of a position statement. We grouped the important aspects for consistent reporting into a "faceted classification"; the components relevant to a particular study to be used independently. The eight facets of our classification are: (1) Theoretical and methodological approach: e.g. dramaturgical, cognitive; (2) DATA COLLECTION: Type and method of observation; (3) Room layout and environment: How this affects interaction between clinician, patient and computer. (4) Initiation and Interaction: Who starts the consultation, and how the participants interact; (5) Information and knowledge utilisation: What sources of information or decision support are used or provided; (6) Timing and type of consultation variables: Standard descriptors that can be used to allow comparison of duration and description of continuous activities (e.g. speech, eye contact) and episodic ones, such as prescribing; (7) Post-consultation impact measures: Satisfaction surveys and health economic assessment based on the perceived quality of the clinician-patient interaction; and (8) Data capture, storage, and export formats: How to archive and curate data to facilitate further analysis. Adoption of this classification should make it easier to interpret research findings and facilitate the synthesis of evidence across studies. Those engaged in IT-consultation research shouldconsider adopting this reporting guide.

Conceptual study of Earth observation missions with a space-borne laser scanner

NASA Astrophysics Data System (ADS)

Kobayashi, Takashi; Sato, Yohei; Yamakawa, Shiro

2017-11-01

The Japan Aerospace Exploration Agency (JAXA) has started a conceptual study of earth observation missions with a space-borne laser scanner (GLS, as Global Laser Scanner). Laser scanners are systems which transmit intense pulsed laser light to the ground from an airplane or a satellite, receive the scattered light, and measure the distance to the surface from the round-trip delay time of the pulse. With scanning mechanisms, GLS can obtain high-accuracy three-dimensional (3D) information from all over the world. High-accuracy 3D information is quite useful in various areas. Currently, following applications are considered. 1. Observation of tree heights to estimate the biomass quantity. 2. Making the global elevation map with high resolution. 3. Observation of ice-sheets. This paper aims at reporting the present state of our conceptual study of the GLS. A prospective performance of the GLS for earth observation missions mentioned above.

Serum uric acid levels and multiple health outcomes: umbrella review of evidence from observational studies, randomised controlled trials, and Mendelian randomisation studies.

PubMed

Li, Xue; Meng, Xiangrui; Timofeeva, Maria; Tzoulaki, Ioanna; Tsilidis, Konstantinos K; Ioannidis, John PA; Campbell, Harry; Theodoratou, Evropi

2017-06-07

Objective  To map the diverse health outcomes associated with serum uric acid (SUA) levels. Design  Umbrella review. Data sources  Medline, Embase, Cochrane Database of Systematic Reviews, and screening of citations and references. Eligibility criteria  Systematic reviews and meta-analyses of observational studies that examined associations between SUA level and health outcomes, meta-analyses of randomised controlled trials that investigated health outcomes related to SUA lowering treatment, and Mendelian randomisation studies that explored the causal associations of SUA level with health outcomes. Results  57 articles reporting 15 systematic reviews and144 meta-analyses of observational studies (76 unique outcomes), 8 articles reporting 31 meta-analyses of randomised controlled trials (20 unique outcomes), and 36 articles reporting 107 Mendelian randomisation studies (56 unique outcomes) met the eligibility criteria. Across all three study types, 136 unique health outcomes were reported. 16 unique outcomes in meta-analyses of observational studies had P<10 -6 , 8 unique outcomes in meta-analyses of randomised controlled trials had P<0.001, and 4 unique outcomes in Mendelian randomisation studies had P<0.01. Large between study heterogeneity was common (80% and 45% in meta-analyses of observational studies and of randomised controlled trials, respectively). 42 (55%) meta-analyses of observational studies and 7 (35%) meta-analyses of randomised controlled trials showed evidence of small study effects or excess significance bias. No associations from meta-analyses of observational studies were classified as convincing; five associations were classified as highly suggestive (increased risk of heart failure, hypertension, impaired fasting glucose or diabetes, chronic kidney disease, coronary heart disease mortality with high SUA levels). Only one outcome from randomised controlled trials (decreased risk of nephrolithiasis recurrence with SUA lowering treatment

Evaluation of Quality of Lower Limb Arthroplasty Observational Studies Using the Assessment of Quality in Lower Limb Arthroplasty (AQUILA) Checklist.

PubMed

Cowan, James B; Mlynarek, Ryan A; Nelissen, Rob G H H; Pijls, Bart G C W; Gagnier, Joel J

2015-09-01

This study used the assessment of quality in lower limb arthroplasty (AQUILA) checklist to assess the quality of lower limb arthroplasty observational studies. Among 132 studies the mean reporting quality score was 5.4 (SD=1.2) out of 8 possible points. Most studies adequately reported reasons for revisions (98%) and prosthesis brand and fixation (95%) in sufficient detail. Only 3% of studies adequately reported the number of patients unwilling to participate, 15% stated a clear primary research question or hypothesis, 11% reported a worst-case analysis or competing risk analysis for endpoints, and 42% reported more than 5% of patients were lost to follow-up. There is significant room for improvement in the reporting and methodology of lower limb arthroplasty observational studies. Level III. Copyright © 2015 Elsevier Inc. All rights reserved.

Ways of learning: Observational studies versus experiments

USGS Publications Warehouse

Shaffer, T.L.; Johnson, D.H.

2008-01-01

Manipulative experimentation that features random assignment of treatments, replication, and controls is an effective way to determine causal relationships. Wildlife ecologists, however, often must take a more passive approach to investigating causality. Their observational studies lack one or more of the 3 cornerstones of experimentation: controls, randomization, and replication. Although an observational study can be analyzed similarly to an experiment, one is less certain that the presumed treatment actually caused the observed response. Because the investigator does not actively manipulate the system, the chance that something other than the treatment caused the observed results is increased. We reviewed observational studies and contrasted them with experiments and, to a lesser extent, sample surveys. We identified features that distinguish each method of learning and illustrate or discuss some complications that may arise when analyzing results of observational studies. Findings from observational studies are prone to bias. Investigators can reduce the chance of reaching erroneous conclusions by formulating a priori hypotheses that can be pursued multiple ways and by evaluating the sensitivity of study conclusions to biases of various magnitudes. In the end, however, professional judgment that considers all available evidence is necessary to render a decision regarding causality based on observational studies.

Use of benzodiazepine and risk of cancer: A meta-analysis of observational studies.

PubMed

Kim, Hong-Bae; Myung, Seung-Kwon; Park, Yon Chul; Park, Byoungjin

2017-02-01

Several observational epidemiological studies have reported inconsistent results on the association between the use of benzodiazepine and the risk of cancer. We investigated the association by using a meta-analysis. We searched PubMed, EMBASE, and the bibliographies of relevant articles to locate additional publications in January 2016. Three evaluators independently reviewed and selected eligible studies based on predetermined selection criteria. Of 796 articles meeting our initial criteria, a total of 22 observational epidemiological studies with 18 case-control studies and 4 cohort studies were included in the final analysis. Benzodiazepine use was significantly associated with an increased risk of cancer (odds ratio [OR] or relative risk [RR] 1.19; 95% confidence interval 1.16-1.21) in a random-effects meta-analysis of all studies. Subgroup meta-analyses by various factors such as study design, type of case-control study, study region, and methodological quality of study showed consistent findings. Also, a significant dose-response relationship was observed between the use of benzodiazepine and the risk of cancer (p for trend <0.01). The current meta-analysis of observational epidemiological studies suggests that benzodiazepine use is associated with an increased risk of cancer. © 2016 UICC.

Patient-Reported Treatment Satisfaction with Rivaroxaban for Stroke Prevention in Atrial Fibrillation. A French Observational Study, the SAFARI Study.

PubMed

Hanon, Olivier; Chaussade, Edouard; Gueranger, Pierre; Gruson, Elise; Bonan, Sabrina; Gay, Alain

2016-01-01

For antithrombotic treatments, Patient Reported Outcomes (PRO) and patient satisfaction with treatment are essential data for physicians because of the strong relationship between patient satisfaction and adherence to treatment. The impact of rivaroxaban on patient satisfaction and quality of life was not sufficiently documented in phase III studies. There is a need for further data in this field especially in real life conditions. The SAFARI study is composed of patients with non-valvular atrial fibrillation (AF), previously treated with vitamin K antagonist (VKA) and switched to rivaroxaban. Patient satisfaction with anticoagulant therapy was measured by the Anti-Clot Treatment Scale (ACTS), a validated 15-item patient-reported scale including a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Satisfaction of medication was compared between baseline and 1, 3 and 6 months. Study population was composed of 405 patients. Mean age was 74.8 (standard deviation = 9.0) years and 63.0% were male. Mean CHA2DS2-VASc score was 3.4 (1.5) and mean HAS-BLED score was 2.9 (1.0). After 3 months of treatment with rivaroxaban, patient satisfaction improved compared with VKA: mean ACTS burdens scores significantly increased by 8.3 (8.9) points (p<0.0001) and ACTS benefits scale by 0.4 (2.9) (p<0.001). Compared with baseline, the improvement in ACTS burdens and benefits became apparent at 1 month (46.5 vs. 53.6 p<0.001 and 10.4 vs. 10.7, p<0.05 respectively) and persisted at 6 months (46.5 vs. 54.76 p<0.001 and 10.4 vs. 10.8 p = 0.02 respectively). Rivaroxaban persistence was 88.7% at 6 months. SAFARI data support a good risk-benefit balance for rivaroxaban, with a good safety profile and encourage PRO design studies. The switch from VKA to rivaroxaban improved patient satisfaction at 1, 3 and 6 months after rivaroxaban initiation among patients with AF, particularly in reducing patient-reported anticoagulation burden.

Profiles of Anger Control in Second-Grade Children: Examination of Self-Report, Observational, and Physiological Components

ERIC Educational Resources Information Center

Smith, Marissa; Hubbard, Julie A.; Laurenceau, Jean-Philippe

2011-01-01

The current study used latent profile analysis (LPA) to examine anger control in 257 second-grade children (approximately 8 years of age). Anger was induced through losing a game and prize to a confederate who cheated. Three components of anger control were assessed: self-report of awareness of anger, observed intensity of angry facial…

Home safety practices in an urban low-income population: level of agreement between parental self-report and observed behaviors.

PubMed

Lee, Lois K; Walia, Taranjeev; Forbes, Peter W; Osganian, Stavroula K; Samuels, Ronald; Cox, Joanne E; Mooney, David P

2012-12-01

Home-related injuries are overrepresented in children from low-income households. The objectives of this study were to determine frequencies of home safety behaviors and the level of agreement between parental self-report and observed safety practices in low-income homes. In a prospective, interventional home injury prevention study of 49 low-income families with children <5 years old, a trained home visitor administered baseline parental home safety behavior questionnaires and assessments. There was high agreement between caregiver self-report and home visitor observation for lack of cabinet latch (99%, 95% confidence interval [CI] = 88%-99%) and stair gate use (100%, 95% CI = 88-100%). There was lower agreement for the safe storage of cleaning supplies (62%, 95% CI = 46%-75%), sharps (74%, 95% CI = 59%-85%), and medicines/vitamins (83%, 95% CI = 69%-92%) because of the overreporting of safe practices. Self-reports of some home safety behaviors are relatively accurate, but certain practices may need to be verified by direct assessment.

An observational study of defensible space in the neighbourhood park

NASA Astrophysics Data System (ADS)

Marzukhi, M. A.; Afiq, M. A.; Zaki, S. Ahmad; Ling, O. H. L.

2018-02-01

The planning of neighborhood park is important to provide space for interaction, leisure, and recreation among residents in any neighbourhood area. However, on an almost daily basis, newspapers report inappropriate incidents such as snatch theft, robbery and street attack that occurred in the neighborhood park. These cases reflect the significance of physical planning and design of neighborhood park that directly affect the safety and comfort of the users. Thus, this study attempts to engage with the defensible space concept in ensuring the security elements be applied in the planning of the recreational area. This study adopts a qualitative method form of research that is retrofitted to an observational study. The observational study is significant for revealing the condition of a neighbourhood park in the ‘real-world,’ in which direct observation is conducted on Taman Tasik Puchong Perdana. The observer focused on four elements or variables of defensible space concept including the provision of facilities in the neighborhood park, territoriality, surveillance, image and milieu. The findings revealed that the planning of Taman Tasik Puchong Perdana does not deliberate the defensible space elements, which may contribute to the crime activities in the park. In these circumstances, the planning of neighbourhood park needs to include proposals for the implementation of defensible space in response to the challenges underpinned by crime problems. Besides, the awareness among the residents needs to be emphasized with the support from local authorities and other organizations to manage and sustain the safety environment in the neighborhood park.

A metadata reporting framework for standardization and synthesis of ecohydrological field observations

NASA Astrophysics Data System (ADS)

Christianson, D. S.; Varadharajan, C.; Detto, M.; Faybishenko, B.; Gimenez, B.; Jardine, K.; Negron Juarez, R. I.; Pastorello, G.; Powell, T.; Warren, J.; Wolfe, B.; McDowell, N. G.; Kueppers, L. M.; Chambers, J.; Agarwal, D.

2016-12-01

The U.S. Department of Energy's (DOE) Next Generation Ecosystem Experiment (NGEE) Tropics project aims to develop a process-rich tropical forest ecosystem model that is parameterized and benchmarked by field observations. Thus, data synthesis, quality assurance and quality control (QA/QC), and data product generation of a diverse and complex set of ecohydrological observations, including sapflux, leaf surface temperature, soil water content, and leaf gas exchange from sites across the Tropics, are required to support model simulations. We have developed a metadata reporting framework, implemented in conjunction with the NGEE Tropics Data Archive tool, to enable cross-site and cross-method comparison, data interpretability, and QA/QC. We employed a modified User-Centered Design approach, which involved short development cycles based on user-identified needs, and iterative testing with data providers and users. The metadata reporting framework currently has been implemented for sensor-based observations and leverages several existing metadata protocols. The framework consists of templates that define a multi-scale measurement position hierarchy, descriptions of measurement settings, and details about data collection and data file organization. The framework also enables data providers to define data-access permission settings, provenance, and referencing to enable appropriate data usage, citation, and attribution. In addition to describing the metadata reporting framework, we discuss tradeoffs and impressions from both data providers and users during the development process, focusing on the scalability, usability, and efficiency of the framework.

Skylab 4 visual observations project report

NASA Technical Reports Server (NTRS)

Kaltenbach, J. L.; Lenoir, W. B.; Mcewen, M. C.; Weitenhagen, R. A.; Wilmarth, V. R.

1974-01-01

The Skylab 4 Visual Observations Project was undertaken to determine the ways in which man can contribute to future earth-orbital observational programs. The premission training consisted of 17 hours of lectures by scientists representing 16 disciplines and provided the crewmen information on observational and photographic procedures and the scientific significance of this information. During the Skylab 4 mission, more than 850 observations and 2000 photographs with the 70-millimeter Hasselblad and 35-millimeter Nikon cameras were obtained for many investigative areas. Preliminary results of the project indicate that man can obtain new and unique information to support satellite earth-survey programs because of his inherent capability to make selective observations, to integrate the information, and to record the data by describing and photographing the observational sites.

Report on the Observation of Binaries in 2013: Humacao University Observatory

NASA Astrophysics Data System (ADS)

Cotto, D.; Muller, R.; Cersosimo, J.; Rodriguez, R.; Diaz, M.; Rosario, M.; Nieves, Y.; Franco, E.; Lopez, A.; Torres, B.; Vergara, N.; Rodriguez-del Valle, Y.; Espinosa, G.; Reyes, M.; Martinez, J.

2017-07-01

This is a report on observations of position angle and separation of binary stars of the year 2013 from the Humacao University Observatory. The stars analyzed totaled 62; they were imaged at the NURO 31 inch telescope in Flagstaff, Arizona in June 2013. The images were analyzed at the Humacao Observatory of the University of Puerto Rico.

Birth Weight and Acute Childhood Leukemia: A Meta-analysis of Observational Studies

DTIC Science & Technology

2005-03-22

22 MAR 2005 2. REPORT TYPE 3. DATES COVERED - 4. TITLE AND SUBTITLE Birth Weight and Acute Childhood Leukemia: A Meta - analysis of Observational...and to quantify the strength of the relationships. We conducted a meta - analysis of nine case-control studies (published between 1991 and 2004...Based on a meta - analysis of only three case-control studies (published between 1997 and 2004) involving over 700 children with AML and over 1,900

Coastal Change Processes Project data report for oceanographic observations near Fire Island, New York, February through May 2014

USGS Publications Warehouse

Armstrong, Brandy N.; Warner, John C.; List, Jeffrey H.; Martini, Marinna A.; Montgomery, Ellyn T.; Traykovski, Peter A.; Voulgaris, George

2015-01-01

An oceanographic field study during February through May 2014 investigated processes that control the sediment-transport dynamics along the western part of Fire Island, New York. This report describes the project background, field program, instrumentation configuration, and locations of the sensors deployed. The data collected, including meteorological observations, are presented as time-series plots for data visualization. Additionally, individual links to the database containing digital data files are available as part of this report.

Carolinas Coastal Change Processes Project data report for observations near Diamond Shoals, North Carolina, January-May 2009

USGS Publications Warehouse

Armstrong, Brandy N.; Warner, John C.; Voulgaris, George; List, Jeffrey H.; Thieler, E. Robert; Martini, Marinna A.; Montgomery, Ellyn T.

2011-01-01

This Open-File Report provides information collected for an oceanographic field study that occurred during January - May 2009 to investigate processes that control the sediment transport dynamics at Diamond Shoals, North Carolina. The objective of this report is to make the data available in digital form and to provide information to facilitate further analysis of the data. The report describes the background, experimental setup, equipment, and locations of the sensor deployments. The edited data are presented in time-series plots for rapid visualization of the data set, and in data files that are in the Network Common Data Format (netcdf). Supporting observational data are also included.

A retrospective observational study of people with Type 1 diabetes with self-reported severe hypoglycaemia reveals high level of ambulance attendance but low levels of therapy change and specialist intervention.

PubMed

Field, B C T; Nayar, R; Kilvert, A; Baxter, M; Hickey, J; Cummings, M; Bain, S C

2018-05-15

To evaluate the impact of severe hypoglycaemia on NHS resources and overall glycaemic control in adults with Type 1 diabetes. An observational, retrospective study of adults (aged ≥ 18 years) with Type 1 diabetes reporting one or more episodes of severe hypoglycaemia during the preceding 24 months in 10 NHS hospital diabetes centres in England and Wales. The primary outcome was healthcare resource utilization associated with severe hypoglycaemia. Secondary outcomes included demographic and clinical characteristics, diabetes control and pathway of care. Some 140 episodes of severe hypoglycaemia were reported by 85 people during the 2-year observation period. Ambulances were called in 99 of 140 (71%) episodes and Accident and Emergency attendance occurred in 26 of 140 (19%) episodes, whereas 29 of 140 (21%) episode required no immediate help from healthcare providers. Participants attended a median of 5 (range 0-58) diabetes clinic consultations during the observation period; 13% (70 of 552) of all consultations were severe hypoglycaemia-related. Of the HbA 1c measurements recorded closest prior to severe hypoglycaemia (n = 119), only 7 of 119 measurements were < 48 mmol/mol (< 6.5%) and mean HbA 1c was 70 (sd 19) mmol/mol (8.5%, sd 1.7%). Some 119 changes to diabetes treatment were recorded during the observation period (median/person 0;, range 0-11), of which 52 of 119 changes (44%) followed severe hypoglycaemic events. We observed a high level of ambulance service intervention but surprisingly low levels of hypoglycaemia follow-up, therapy change and specialist intervention in people self-reporting severe hypoglycaemia. These results suggest there may be important gaps in care pathways for people with Type 1 diabetes self-reporting severe hypoglycaemia. © 2018 Diabetes UK.

Drug Utilization on Neonatal Wards: A Systematic Review of Observational Studies

PubMed Central

Rosli, Rosliana; Dali, Ahmad Fauzi; Abd Aziz, Noorizan; Abdullah, Amir Heberd; Ming, Long Chiau; Manan, Mohamed Mansor

2017-01-01

Despite limited evidence on safety and efficacy of drug use in neonates, drugs are extensively used in this age group. However, the availability of information on drug consumption in neonates, especially inpatient neonates, is limited. This paper systematically reviews published studies on drug utilization in hospitalized neonates. A systematic literature review was carried out to identify observational studies published from inception of databases used till August 2016. Four search engines, namely Medline, CINAHL, Embase, and PubMed, were used. Publications written in English that described drug utilization in neonatal wards were selected. Assessment of the data was based on the category of the study design, the objective of study and the method used in reporting drug consumption. A total of 20 drug utilization studies were identified, 12 of which focused on all drug classes, while the other eight evaluated antimicrobials. Studies were reported in Europe (n = 7), the United States (n = 6), India (n = 5), Brazil (n = 1), and Iran (n = 1). Substantial variance with regard to study types (study design and methods), data source, and sample size were found among the selected studies. Of the studies included, 45% were cross-sectional or retrospective, 40% were prospective studies, and the remaining 15% were point prevalence surveys. More than 70% of the studies were descriptive studies, describing drug consumption patterns. Fifteen per cent of the descriptive studies evaluated changes in drug utilization patterns in neonates. Volume of units was the most prevalent method used for reporting all drug categories. The ATC/DDD system for reporting drug use was only seen in studies evaluating antimicrobials. The most commonly reported drugs across all studies are anti-infectives for systemic use, followed by drugs for the cardiovascular system, the nervous system and the respiratory system. Ampicillin and gentamicin were the most prescribed antimicrobials in hospitalized

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults

PubMed Central

Meddeler, Bart M.; Hoogeboom, Thomas J.; Nijhuis-van der Sanden, Maria W. G.; van Cingel, Robert E. H.

2017-01-01

Context Since decades leg dominance is suggested to be important in rehabilitation and return to play in athletes with anterior cruciate ligament injuries. However, an ideal method to determine leg dominance in relation to task performance is still lacking. Objective To test the agreement between self-reported and observed leg dominance in bilateral mobilizing and unilateral stabilizing tasks, and to assess whether the dominant leg switches between bilateral mobilizing tasks and unilateral stabilizing tasks. Design Cross-sectional study. Participants Forty-one healthy adults: 21 men aged 36 ± 17 years old and 20 women aged 36 ±15 years old. Measurement and analysis Participants self-reported leg dominance in the Waterloo Footedness Questionnaire-Revised (WFQ-R), and leg dominance was observed during performance of four bilateral mobilizing tasks and two unilateral stabilizing tasks. Descriptive statistics and crosstabs were used to report the percentages of agreement. Results The leg used to kick a ball had 100% agreement between the self-reported and observed dominant leg for both men and women. The dominant leg in kicking a ball and standing on one leg was the same in 66.7% of the men and 85.0% of the women. The agreement with jumping with one leg was lower: 47.6% for men and 70.0% for women. Conclusions It is appropriate to ask healthy adults: “If you would shoot a ball on a target, which leg would you use to shoot the ball?” to determine leg dominance in bilateral mobilizing tasks. However, a considerable number of the participants switched the dominant leg in a unilateral stabilizing task. PMID:29287067

Travel-related morbidity in children: a prospective observational study.

PubMed

van Rijn, Suzanne F; Driessen, Gertjan; Overbosch, David; van Genderen, Perry J J

2012-01-01

Scarce data are available on the occurrence of ailments and diseases in children during travel. We studied the characteristics and frequencies of ailments in children aged 0 to 18 years and their parents during traveling. A prospective observational study on ailments reported by children and parents traveling to (sub)tropical countries was conducted. The ailments were semi-quantitatively graded as mild, moderate, or severe; ailments were expressed as ailment rates per personmonth of travel. A total of 152 children and 47 parents kept track of their ailments for a total of 497 and 154 weeks, respectively. The children reported a mean ailment rate of 7.0 (5.6-8.4) ailments per personmonth of travel; 17.4% of the ailments were graded as moderate and 1.4% as severe. The parents reported a mean ailment rate of 4.4 (3.1-5.7); 10.8% of the ailments were graded as moderate and 5.5% as severe. Skin problems like insect bites, sunburn and itch, and abdominal complaints like diarrhea were frequently reported ailments in both children and parents. Children in the age category 12 to 18 years showed a significantly higher ailment rate of 11.2 (6.8-14.1) than their parents. Skin problems and abdominal problems like diarrhea are frequently reported ailments in children and their parents and show a high tendency to recur during travel. The majority of these ailments are mild but occasionally interfere with planned activities. Children in the age group 12 to 18 years are at a greater risk of developing ailments during a stay in a (sub)tropical country and they should be actively informed about the health risks of traveling to the tropics. © 2011 International Society of Travel Medicine.

Comparison of food safety cognitions and self-reported food-handling behaviors with observed food safety behaviors of young adults.

PubMed

Abbot, J M; Byrd-Bredbenner, C; Schaffner, D; Bruhn, C M; Blalock, L

2009-04-01

Developing tailored and effective food safety education for young adults is critical given their future roles as caregivers likely to be preparing food for populations who may be at greater risk for foodborne disease (FBD). The objective of this study was to examine the relationship between food safety self-reported food-handling behaviors and cognitions of young adults to observed food-handling behaviors. Participants were 153 young adults (mean age 20.74+/-1.30 s.d.) attending a major American university. Each prepared a meal under observation in a controlled laboratory setting, permitted researchers to observe their home kitchen and completed an online survey assessing food safety knowledge, behavior and psychosocial measures. Descriptive statistics were generated for participants' self-reported food-handling behaviors, psychosocial characteristics, knowledge, food preparation observations and home kitchen observations. Determinants of compliance with safe food-handling procedures while preparing a meal and home food storage/rotation practices were identified using backward regression models. Participants engaged in less than half of the recommended safe food-handling practices evaluated and correctly answered only two-thirds of the food safety knowledge items. They reported positive food safety beliefs and high food safety self-efficacy. Self-reported compliance with cross-contamination prevention, disinfection procedures and knowledge of groups at greatest risk for FBD were the best measures for predicting compliance with established safe food-handling practices. Food safety education directed toward young adults should focus on increasing awareness of FBD and knowledge of proper cross-contamination prevention procedures to help promote better compliance with actual safe food handling.

Global Positioning System: Observations on Quarterly Reports from the Air Force

DTIC Science & Technology

2016-10-17

Positioning System : Observations on Quarterly Reports from the Air Force The satellite-based Global Positioning System (GPS) provides positioning, navigation...infrastructure, and transportation safety. The Department of Defense (DOD)—specifically, the Air Force—develops and operates the GPS system , which...programs, including the most recent detailed assessment of the next generation operational control system (OCX) and development of military GPS

Cultivating cohort studies for observational translational research.

PubMed

Ransohoff, David F

2013-04-01

"Discovery" research about molecular markers for diagnosis, prognosis, or prediction of response to therapy has frequently produced results that were not reproducible in subsequent studies. What are the reasons, and can observational cohorts be cultivated to provide strong and reliable answers to those questions? Experimental Selected examples are used to illustrate: (i) what features of research design provide strength and reliability in observational studies about markers of diagnosis, prognosis, and response to therapy? (ii) How can those design features be cultivated in existing observational cohorts, for example, within randomized controlled clinical trial (RCT), other existing observational research studies, or practice settings like health maintenance organization (HMOs)? Examples include a study of RNA expression profiles of tumor tissue to predict prognosis of breast cancer, a study of serum proteomics profiles to diagnose ovarian cancer, and a study of stool-based DNA assays to screen for colon cancer. Strengths and weaknesses of observational study design features are discussed, along with lessons about how features that help assure strength might be "cultivated" in the future. By considering these examples and others, it may be possible to develop a process of "cultivating cohorts" in ongoing RCTs, observational cohort studies, and practice settings like HMOs that have strong features of study design. Such an effort could produce sources of data and specimens to reliably answer questions about the use of molecular markers in diagnosis, prognosis, and response to therapy.

Exploring the Ethics of Observational Research: The Case of an HIV Study in Tanzania

PubMed Central

Norris, Alison; Jackson, Ashley; Khoshnood, Kaveh

2013-01-01

Background Observational studies have generally been viewed as incurring minimal risk to participants, resulting in fewer ethical obligations for investigators than intervention studies. In 2004, the lead author (AN) carried out an observational study measuring sexual behavior and the prevalence of HIV, syphilis, and herpes simplex virus type 2 (HSV-2), among Tanzanian agricultural plantation residents (results reported elsewhere). This article uses an ethical lens to consider the consequences of the observational study and explore what, if any, effects it had on participants and their community. Methods Using a case study approach, we critically examine three core principles of research ethics—respect for persons/autonomy; beneficence/nonmaleficence; and distributive justice—as manifested in the 2004 observational study. We base our findings on three sources: discussions with plantation residents following presentations of observational research findings; in-depth interviews with key informants; and researcher observations. Results The observational research team was found to have ensured confidentiality and noncoercive recruitment. Ironically, maintenance of confidentiality and voluntary participation led some participants to doubt study results. Receiving HIV test results was important for participants and contributed to changing community norms about HIV testing. Conclusions Observational studies may act like de facto intervention studies and thus incur obligations similar to those of intervention studies. We found that ensuring respect for persons may have compromised the principles of beneficence and distributive justice. While in theory these three ethical principles have equal moral force, in practice, researchers may have to prioritize one over the others. Careful community engagement is necessary to promote well-considered ethical decisions. PMID:24069546

Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

PubMed

Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

2016-01-28

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

Long-Term Oceanographic Observations in Western Massachusetts Bay Offshore of Boston, Massachusetts: Data Report for 1989-2002

USGS Publications Warehouse

Butman, Bradford; Bothner, Michael H.; Alexander, P. Soupy; Lightsom, Frances L.; Martini, Marinna A.; Gutierrez, Benjamin T.; Strahle, William S.

2004-01-01

This data report presents long-term oceanographic observations made in western Massachusetts Bay at two locations: (1) 42 deg 22.6' N., 70 deg 47.0' W. (Site A, 33 m water depth) from December 1989 through December 2002 (figure 1), and (2) 42 deg 9.8' N., 70 deg 38.4' W. (Site B, 21 m water depth) from October 1997 through December 2002. Site A is approximately 1 km south of the new ocean outfall that began discharging treated sewage effluent from the Boston metropolitan area into Massachusetts Bay on September 6, 2000. These long-term oceanographic observations have been collected by the U.S. Geological Survey (USGS) in partnership with the Massachusetts Water Resources Authority (MWRA) and with logistical support from the U.S. Coast Guard (USCG - http://www.uscg.mil). This report presents time series data through December 2002, updating a similar report that presented data through December 2000 (Butman and others, 2002). In addition, the Statistics and Mean Flow sections include some new plots and tables and the format of the report has been streamlined by combining yearly figures into single .pdfs. Figure 1 (PDF format) The long-term measurements are planned to continue at least through 2005. The long-term oceanographic observations at Sites A and B are part of a USGS study designed to understand the transport and long-term fate of sediments and associated contaminants in the Massachusetts bays. (See http://woodshole.er.usgs.gov/project-pages/bostonharbor/ and Butman and Bothner, 1997.) The long-term observations document seasonal and inter-annual changes in currents, hydrography, and suspended-matter concentration in western Massachusetts Bay, and the importance of infrequent catastrophic events, such as major storms or hurricanes, in sediment resuspension and transport. They also provide observations for testing numerical models of circulation. This data report presents a description of the field program and instrumentation, an overview of the data through

First Report on the 2016 March 9 Total Solar Eclipse Observations

NASA Astrophysics Data System (ADS)

Pasachoff, Jay M.

2016-06-01

Totality swept across Indonesia and into the Pacific on 2016 March 9, lasting up to 2 min 45 s on Ternate in the Spice Islands (Malukus). I provide a first report on our observations. Our scientific goal is to follow changes in the corona over the solar-activity cycle, now past its 2012 and 2014 double peak, and to measure temporal changes in the corona on the scale of minutes or hours by comparing eclipse observations made at several sites along the path. I also discuss the near-simultaneous coronal observations made with SOHO/LASCO, SDO/AIA, STEREO/SECCHI, PROBA2/SWAP, and Hinode XRT.For the forthcoming 2017 eclipse, we acknowledge grants to JMP and Williams College from the Solar Terrestrial Program of the Atmospheric and Geospace Sciences Division of the National Science Foundation and from the Committee for Research and Exploration of the National Geographic Society.

Medication safety research by observational study design.

PubMed

Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

2016-06-01

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

Bleeding risk under selective serotonin reuptake inhibitor (SSRI) antidepressants: A meta-analysis of observational studies.

PubMed

Laporte, Silvy; Chapelle, Céline; Caillet, Pascal; Beyens, Marie-Noëlle; Bellet, Florelle; Delavenne, Xavier; Mismetti, Patrick; Bertoletti, Laurent

2017-04-01

Selective serotonin reuptake inhibitors (SSRIs) have been reported to be potentially associated with an increased risk of bleeding. A meta-analysis of observational studies was conducted to quantify this risk. Case-control and cohort studies investigating bleeding risk under SSRI therapy were retrieved by searching the Medline, Pascal, Google Scholar and Scopus databases. Case-control studies were included if they reported bleeding incidents with and without the use of SSRIs and cohort studies were included if they reported the rate of bleeds among SSRI users and non-users. The main outcome was severe bleeding, whatever the site. Only data concerning SSRI belonging to the ATC class N06AB were used. For both case-control and cohort studies, we recorded the adjusted effect estimates and their 95% confidence intervals (CI). Pooled adjusted odds ratio (OR) estimates were computed for case-control and cohort studies using an inverse-variance model. Meta-analysis of the adjusted ORs of 42 observational studies showed a significant association between SSRI use and the risk of bleeding [OR 1.41 (95% CI 1.27-1.57), random effect model, p<0.0001]. The association was found for the 31 case-control studies (1,255,073 patients), with an increased risk of 41% of bleeding [OR 1.41 (95% CI 1.25-1.60)], as well as for the 11 cohort studies including 187,956 patients [OR 1.36 (95% CI 1.12-1.64)]. Subgroup analyses showed that the association remained constant whatever the characteristics of studies. This meta-analysis shows an increased risk of bleeding of at least 36% (from 12% to 64%) based on the high-level of observational studies with SSRIs use. Copyright © 2016 Elsevier Ltd. All rights reserved.

An observational study of agreement between percentage pain reduction calculated from visual analog or numerical rating scales versus that reported by parturients during labor epidural analgesia.

PubMed

Pratici, E; Nebout, S; Merbai, N; Filippova, J; Hajage, D; Keita, H

2017-05-01

This study aimed to determine the level of agreement between calculated percentage pain reduction, derived from visual analog or numerical rating scales, and patient-reported percentage pain reduction in patients having labor epidural analgesia. In a prospective observational study, parturients were asked to rate their pain intensity on a visual analog scale and numerical rating scale, before and 30min after initiation of epidural analgesia. The percentage pain reduction 30min after epidural analgesia was calculated by the formula: 100×(score before epidural analgesia-score 30min after epidural analgesia)/score before epidural analgesia. To evaluate agreement between calculated percentage pain reduction and patient-reported percentage pain reduction, we computed the concordance correlation coefficient and performed Bland-Altman analysis. Ninety-seven women in labor were enrolled in the study, most of whom were nulliparous, with a singleton fetus and in spontaneous labor. The concordance correlation coefficient with patient-reported percentage pain reduction was 0.76 (95% CI 0.6 to 0.8) and 0.77 (95% CI 0.6 to 0.8) for the visual analog and numerical rating scale, respectively. The Bland-Altman mean difference between calculated percentage pain reduction and patient-reported percentage pain reduction for the visual analog and numerical rating scales was -2.0% (limits of agreement at 29.8%) and 0 (limits of agreement at 28.2%), respectively. The agreement between calculated percentage pain reduction from a visual analog or numerical rating scale and patient-reported percentage pain reduction in the context of labor epidural analgesia was moderate. The difference could range up to 30%. Patient-reported percentage pain reduction has advantages as a measurement tool for assessing pain management for childbirth but differences compared with other assessment methods should be taken into account. Copyright © 2017 Elsevier Ltd. All rights reserved.

Aviation Weather Observations for Supplementary Aviation Weather Reporting Stations (SAWRS) and Limited Aviation Weather Reporting Stations (LAWRS). Federal Meteorological Handbook No. 9.

ERIC Educational Resources Information Center

Department of Transportation, Washington, DC.

This handbook provides instructions for observing, identifying, and recording aviation weather at Limited Aviation Weather Reporting Stations (LAWRS) and Supplementary Aviation Weather Reporting Stations (SAWRS). Official technical definitions, meteorological and administrative procedures are outlined. Although this publication is intended for use…

Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

PubMed Central

Dahabreh, Issa J.; Sheldrick, Radley C.; Paulus, Jessica K.; Chung, Mei; Varvarigou, Vasileia; Jafri, Haseeb; Rassen, Jeremy A.; Trikalinos, Thomas A.; Kitsios, Georgios D.

2012-01-01

Aims Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of therapeutic interventions because randomization protects from biases inherent in observational studies. Propensity score (PS) methods, proposed as a potential solution to confounding of the treatment–outcome association, are widely used in observational studies of therapeutic interventions for acute coronary syndromes (ACS). We aimed to systematically assess agreement between observational studies using PS methods and RCTs on therapeutic interventions for ACS. Methods and results We searched for observational studies of interventions for ACS that used PS methods to estimate treatment effects on short- or long-term mortality. Using a standardized algorithm, we matched observational studies to RCTs based on patients’ characteristics, interventions, and outcomes (‘topics’), and we compared estimates of treatment effect between the two designs. When multiple observational studies or RCTs were identified for the same topic, we performed a meta-analysis and used the summary relative risk for comparisons. We matched 21 observational studies investigating 17 distinct clinical topics to 63 RCTs (median = 3 RCTs per observational study) for short-term (7 topics) and long-term (10 topics) mortality. Estimates from PS analyses differed statistically significantly from randomized evidence in two instances; however, observational studies reported more extreme beneficial treatment effects compared with RCTs in 13 of 17 instances (P = 0.049). Sensitivity analyses limited to large RCTs, and using alternative meta-analysis models yielded similar results. Conclusion For the treatment of ACS, observational studies using PS methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant. PMID:22711757

Reliability of patient-reported outcomes in rheumatoid arthritis patients: an observational prospective study.

PubMed

Studenic, Paul; Stamm, Tanja; Smolen, Josef S; Aletaha, Daniel

2016-01-01

Patient-reported outcomes (PROs) such as pain, patient global assessment (PGA) and fatigue are regularly assessed in RA patients. In the present study, we aimed to explore the reliability and smallest detectable differences (SDDs) of these PROs, and whether the time between assessments has an impact on reliability. Forty RA patients on stable treatment reported the three PROs daily over two subsequent months. We assessed the reliability of these measures by calculating intraclass correlation coefficients (ICCs) and the SDDs for 1-, 7-, 14- and 28-day test-retest intervals. Overall, SDD and ICC were 25 mm and 0.67 for pain, 25 mm and 0.71 for PGA and 30 mm and 0.66 for fatigue, respectively. SDD was higher with longer time period between assessments, ranging from 19 mm (1-day intervals) to 30 mm (28-day intervals) for pain, 19 to 33 mm for PGA, and 26 to 34 mm for fatigue; correspondingly, ICC was smaller with longer intervals, and ranged between the 1- and the 28-day interval from 0.80 to 0.50 for pain, 0.83 to 0.57 for PGA and 0.76 to 0.58 for fatigue. The baseline simplified disease activity index did not have any influence on reliability. Lower baseline PRO scores led to smaller SDDs. Reliability of pain, PGA and fatigue measurements is dependent on the tested time interval and the baseline levels. The relatively high SDDs, even for patients in the lowest tertiles of their PROs, indicate potential issues for assessment of the presence of remission. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Sites, frequencies, and causes of self-reported fractures in 9,720 rheumatoid arthritis patients: a large prospective observational cohort study in Japan.

PubMed

Ochi, Kensuke; Furuya, Takefumi; Ikari, Katsunori; Taniguchi, Atsuo; Yamanaka, Hisashi; Momohara, Shigeki

2013-01-01

Sites, frequencies, and causes of self-reported fractures in Japanese patients with rheumatoid arthritis (RA) were evaluated in a prospective, observational cohort study. The incidence and cause of fracture differ by anatomical site, sex, and age. These differences may be considered in establishing custom strategies for preventing fractures in RA patients in the future. The literature contains limited data describing the details of fractures at different skeletal sites in patients with RA. We evaluated the details of fractures in Japanese RA patients on the basis of our Institute of Rheumatology Rheumatoid Arthritis cohort study in 9,720 RA patients (82 % women; mean age, 56 years) who were enrolled from 2000 to 2010. The details of fractures were obtained through biannual patient self-report questionnaires. Over a mean duration of 5.2 years, 1,317 patients (13.5 %) reported 2,323 incident fractures comprising 563 (24.2 %) clinical vertebral fractures and 1,760 (75.8 %) nonvertebral fractures. Rib fractures were the most common fractures in men, followed by clinical vertebral and hip fractures; the most common fractures in women were clinical vertebral fractures, followed by rib, foot, and hip fractures. There was a significant difference between sexes in the rates of rib, clavicle, shoulder, and ankle fractures. Spontaneous event was the primary cause of clinical vertebral fracture (65.4 %), whereas falls were the primary cause of upper extremity (76.5 %) and lower extremity (57.8 %) fractures. Rates of clinical vertebral and hip fractures increased, while those of rib and foot fractures decreased with increasing age. Incidence of falls, as causes of nonvertebral fractures, also increased in older age groups. Our results suggest that the causes of fractures may differ depending on anatomical site and that prevention of falls may be the most effective way to reduce upper and lower extremity fractures, especially in older patients with RA.

FRAMES Metadata Reporting Templates for Ecohydrological Observations, version 1.1

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

Christianson, Danielle; Varadharajan, Charuleka; Christoffersen, Brad

FRAMES is a a set of Excel metadata files and package-level descriptive metadata that are designed to facilitate and improve capture of desired metadata for ecohydrological observations. The metadata are bundled with data files into a data package and submitted to a data repository (e.g. the NGEE Tropics Data Repository) via a web form. FRAMES standardizes reporting of diverse ecohydrological and biogeochemical data for synthesis across a range of spatiotemporal scales and incorporates many best data science practices. This version of FRAMES supports observations for primarily automated measurements collected by permanently located sensors, including sap flow (tree water use), leafmore » surface temperature, soil water content, dendrometry (stem diameter growth increment), and solar radiation. Version 1.1 extend the controlled vocabulary and incorporates functionality to facilitate programmatic use of data and FRAMES metadata (R code available at NGEE Tropics Data Repository).« less

Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies

PubMed Central

2017-01-01

This study aimed to assess whether night shift work is associated with the risk of depression by using a meta-analysis of observational studies. We searched PubMed and EMBASE in August, 2016 to locate eligible studies and investigated the association between night shift work and the risk of depression, reporting outcome measures with adjusted odds ratios (ORs) or relative risks (RRs) and 95% confidence intervals (CIs). In the meta-analysis of a total of 11 observational studies with 9 cross-sectional study, 1 longitudinal study, and 1 cohort study, night shift work was significantly associated with an increased risk of depression (OR/RR, 1.43; 95% CI, 1.24–1.64; I2 = 78.0%). Also, subgroup meta-analyses by gender, night shift work duration, type of occupation, continent, and type of publication showed that night shift work was consistently associated with the increased risk of depression. The current meta-analysis suggests that night shift work is associated with the increased risk of depression. However, further large prospective cohort studies are needed to confirm this association. PMID:28581264

CEOS Committee on Earth Observations Satellites Consolidated Report, 1992

NASA Technical Reports Server (NTRS)

1992-01-01

A concise overview of the committee on Earth Observations Satellites (CEOS) and its Working Groups, covering the history and purpose of the Committee and its accomplishments to date are provided. The report will be updated annually before each Plenary meeting, and as developments in the Working Groups warrant. The committee on Earth Observations Satellites (originally named the International Earth Observations Satellite committee, IEOS) was treated in 1984, in response to a recommendation from the Economic Summit of Industrialized Nations Working Group on Growth, Technology, and Employment's Panel of Experts on Satellite Remote Sensing. This group recognized the multidisciplinary nature of satellite Earth observations, and the value of coordinating across all proposed missions. Thus, CEOS combined the previously existing groups for coordination on Ocean Remote-Sensing Satellites (CORSS) and coordination on Land Remote-Sensing Satellites (CLRSS), and established a broad framework for coordination across all spaceborne Earth observations missions. The first three LEOS Plenary meetings focused on treating and guiding the Working Groups deemed necessary to carry out the objectives of the CEOS members. After the third meeting, it was agreed that a more active orientation was required by the Plenary, and additional issues were brought before the group at the fourth meeting. At the fifth Plenary, international scientific programs and relevant intergovernmental organizations accepted invitations and participated as affiliate members of CEOS. This enabled progress toward integrating satellite data users' requirements into the CEOS process. Data exchange principles for global change research were also adopted. An interim CEOS Plenary meeting was held in April 1992, in preparation for the United Nations Conference on Environment and Development (UNCED). Brief encapsulations of the Plenary sessions immediately follow the Terms of Reference that govern the activities of CEOS as

Lower Risk of Death With SGLT2 Inhibitors in Observational Studies: Real or Bias?

PubMed

Suissa, Samy

2018-01-01

Two recent observational studies reported a remarkably lower rate of all-cause death associated with sodium-glucose cotransporter 2 inhibitor (-SGLT2i) use in all patients with type 2 diabetes and not only those at increased cardiovascular risk. The >50% lower mortality rates reported in these studies are much greater than those found in the BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) and CANagliflozin cardioVascular Assessment Study (CANVAS) randomized trials. We show that these observational studies are affected by time-related biases, including immortal time bias and time-lag bias, which tend to exaggerate the benefits observed with a drug. The Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors (CVD-REAL) study, based on 166,033 users of SGLT2i and 1,226,221 users of other glucose-lowering drugs (oGLD) identified from health care databases of six countries, was affected by immortal time bias. Indeed, the immortal time between the first oGLD prescription and the first SGLT2i prescription was omitted from the analysis, which resulted in increasing the rate of death in the oGLD group and thus producing the appearance of a lower risk of death with SGLT2i use. The Swedish study compared 10,879 SGLT2i/dipeptidyl peptidase 4 inhibitor (DPP-4i) users with 10,879 matched insulin users. Such comparisons involving second-line therapies with a third-line therapy can introduce time-lag bias, as the patients may not be at the same stage of diabetes. This bias is compounded by the fact that the users of insulin had already started their insulin before cohort entry, unlike the new users of SGLT2i. Finally, the study also introduces immortal time bias with respect to the effects of SGLT2i relative to DPP-4i. In conclusion, the >50% lower rate of death with SGLT2i in type 2 diabetes reported by two recent observational studies is likely exaggerated by immortal time and time

Observational Study of Ion Diffusion Region tailward of the Cusp: Polar and Cluster Observations in 1998-2008

NASA Astrophysics Data System (ADS)

Muzamil, F. M.; Farrugia, C. J.; Torbert, R. B.; Argall, M. R.; Wang, S.

2015-12-01

Asymmetries in plasma density and the presence of a guide field significantly alter the structure of the ion diffusion region (IDR) in symmetric, collisionless reconnection. These features have been shown by numerical simulations under moderate density asymmetries (~10), and theoretical analyses. However, very few studies have addressed these issues with in-situ observations. We have compiled a collection of Cluster and Polar crossings of the high-latitude magnetopause poleward of the cusp under northward interplanetary magnetic field in the years 1998-2008 when signatures of reconnection inside the IDR are observed. They encompass a wide range of density asymmetries (~10 to 1000), magnetic field asymmetries (~0.2 to 0.9), and guide fields (~10 to ~60 %). In this dedicated observational study, we target the following topics: (1) The alteration of the structure of the IDR -- i.e., its width, the non-colocation of stagnation and X-lines, jet outflow speed, and biasing of the reconnection outflow jet toward the magnetosphere -- as a function of increasing density asymmetry, and (2) the diamagnetic drift of the X-line. Further, focusing on IDR crossings during plasma flow reversals and/or near-simultaneous crossings on either side of the X-line by two spacecraft under steady ambient conditions, we report on the contrast in the Hall fields and the plasma behavior on the sunward versus the tailward sides of the X-line in its dependence on the strength of the guide field.

A review of published analyses of case-cohort studies and recommendations for future reporting.

PubMed

Sharp, Stephen J; Poulaliou, Manon; Thompson, Simon G; White, Ian R; Wood, Angela M

2014-01-01

The case-cohort study design combines the advantages of a cohort study with the efficiency of a nested case-control study. However, unlike more standard observational study designs, there are currently no guidelines for reporting results from case-cohort studies. Our aim was to review recent practice in reporting these studies, and develop recommendations for the future. By searching papers published in 24 major medical and epidemiological journals between January 2010 and March 2013 using PubMed, Scopus and Web of Knowledge, we identified 32 papers reporting case-cohort studies. The median subcohort sampling fraction was 4.1% (interquartile range 3.7% to 9.1%). The papers varied in their approaches to describing the numbers of individuals in the original cohort and the subcohort, presenting descriptive data, and in the level of detail provided about the statistical methods used, so it was not always possible to be sure that appropriate analyses had been conducted. Based on the findings of our review, we make recommendations about reporting of the study design, subcohort definition, numbers of participants, descriptive information and statistical methods, which could be used alongside existing STROBE guidelines for reporting observational studies.

Factors Associated with Alignment between Teacher Survey Reports and Classroom Observation Ratings of Mathematics Instruction

ERIC Educational Resources Information Center

Kaufman, Julia Heath; Stein, Mary Kay; Junker, Brian

2016-01-01

We investigated the alignment between a teacher survey self-report measure and classroom observation measure of ambitious mathematics instructional practice among teachers in two urban school districts using two different standards-based mathematics curricula. Survey reports suggested mild differences in teachers' instructional practices between…

Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

ERIC Educational Resources Information Center

Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

2011-01-01

We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

Parturient perineal distensibility tolerance assessed by EPI-NO: an observational study.

PubMed

Nakamura, Mary Uchiyama; Sass, Nelson; Elito Júnior, Julio; Petricelli, Carla Dellabarba; Alexandre, Sandra Maria; Araujo Júnior, Edward; Zanetti, Miriam Raquel Diniz

2014-01-01

To determine how parturient women tolerate the use of a perineal distensibility assessment technique using the EPI-NO device. An observational study with a total of 227 full-term parturient women was performed. During the evaluation with EPI-NO, parturient patients were asked about their sensation of discomfort. The degree of discomfort was measured using the Visual Analogue Scale, with a score from zero to 10. The Mann-Whitney test was applied to assess perineal distensibility measured by EPI-NO and the degree of discomfort caused by the test according to parity. The relation between perineal distensibility and discomfort was analyzed by using the Spearman correlation test (r). The test with EPI-NO caused only slight discomfort (mean Visual Analogue Scale of 3.8), and primiparous women reported significantly greater discomfort (mean Visual Analogue Scale of 4.5) than did multiparous (mean Visual Analogue Scale=3.1), with p<0.001 women. A negative correlation was observed, in other words, the greater the perineal distensibility on the EPI-NO, the lower the pain reported by the patients (r=-0.424; p<0.001). The assessment of perineal distensibility with EPI-NO was well tolerated by the parturient women.

Treatment of Crohn's disease with cannabis: an observational study.

PubMed

Naftali, Timna; Lev, Lihi Bar; Yablecovitch, Doron; Yablekovitz, Doron; Half, Elisabeth; Konikoff, Fred M

2011-08-01

The marijuana plant cannabis is known to have therapeutic effects, including improvement of inflammatory processes. However, no report of patients using cannabis for Crohn's disease (CD) was ever published. To describe the effects of cannabis use in patients suffering from CD. In this retrospective observational study we examined disease activity, use of medication, need for surgery, and hospitalization before and after cannabis use in 30 patients (26 males) with CD. Disease activity was assessed by the Harvey Bradshaw index for Crohn's disease. Of the 30 patients 21 improved significantly after treatment with cannabis. The average Harvey Bradshaw index improved from 14 +/- 6.7 to 7 +/- 4.7 (P < 0.001). The need for other medication was significantly reduced. Fifteen of the patients had 19 surgeries during an average period of 9 years before cannabis use, but only 2 required surgery during an average period of 3 years of cannabis use. This is the first report of cannabis use in Crohn's disease in humans. The results indicate that cannabis may have a positive effect on disease activity, as reflected by reduction in disease activity index and in the need for other drugs and surgery. Prospective placebo-controlled studies are warranted to fully evaluate the efficacy and side effects of cannabis in CD.

The Relations among Observational, Physiological, and Self-Report Measures of Children's Anger

ERIC Educational Resources Information Center

Hubbard, Julie A.; Parker, Elizabeth H.; Ramsden, Sally R.; Flanagan, Kelly D.; Relyea, Nicole; Dearing, Karen F.; Smithmyer, Catherine M.; Simons, Robert F.; Hyde, Christopher T.

2004-01-01

Our first goal was to examine the relations among observational, physiological, and self-report measures of children's anger. Our second goal was to investigate whether these relations varied by reactive or proactive aggression. Children (272 second-grade boys and girls) participated in a procedure in which they lost a game and prize to a…

Embedding clinical interventions into observational studies

PubMed Central

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

2017-01-01

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

Regression-Based Estimates of Observed Functional Status in Centenarians

PubMed Central

Mitchell, Meghan B.; Miller, L. Stephen; Woodard, John L.; Davey, Adam; Martin, Peter; Burgess, Molly; Poon, Leonard W.

2011-01-01

Purpose of the Study: There is lack of consensus on the best method of functional assessment, and there is a paucity of studies on daily functioning in centenarians. We sought to compare associations between performance-based, self-report, and proxy report of functional status in centenarians. We expected the strongest relationships between proxy reports and observed performance of basic activities of daily living (BADLs) and instrumental activities of daily living (IADLs). We hypothesized that the discrepancy between self-report and observed daily functioning would be modified by cognitive status. We additionally sought to provide clinicians with estimates of centenarians’ observed daily functioning based on their mental status in combination with subjective measures of activities of daily living (ADLs). Design and Methods: Two hundred and forty-four centenarians from the Georgia Centenarian Study were included in this cross-sectional population-based study. Measures included the Direct Assessment of Functional Status, self-report and proxy report of functional status, and the Mini-Mental State Examination (MMSE). Results: Associations between observed and proxy reports were stronger than between observed and self-report across BADL and IADL measures. A significant MMSE by type of report interaction was found, indicating that lower MMSE performance is associated with a greater discrepancy between subjective and objective ADL measures. Implications: Results demonstrate associations between 3 methods of assessing functional status and suggest proxy reports are generally more accurate than self-report measures. Cognitive status accounted for some of the discrepancy between observed and self-reports, and we provide clinicians with tables to estimate centenarians’ performance on observed functional measures based on MMSE and subjective report of functional status. PMID:20974657

The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

PubMed

Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

2017-07-01

This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

Embedding clinical interventions into observational studies.

PubMed

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

2016-01-01

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

Globular-cluster stars - Results of theoretical evolution and pulsation studies compared with the observations.

NASA Technical Reports Server (NTRS)

Iben, I., Jr.

1971-01-01

Survey of recently published studies on globular clusters, and comparison of stellar evolution and pulsation theory with reported observations. The theory of stellar evolution is shown to be capable of describing, in principle, the behavior of a star through all quasi-static stages. Yet, as might be expected, estimates of bulk properties obtained by comparing observations with results of pulsation and stellar atmosphere theory differ somewhat from estimates of these same properties obtained by comparing observations with results of evolution theory. A description is given of how such estimates are obtained, and suggestions are offered as to where the weak points in each theory may lie.

2003 Mars Report from Cooperative Observation Networks. II. After the Opposition

NASA Astrophysics Data System (ADS)

Nakakushi, Takashi; Adachi, Makoto; Iga, Yuichi; Ikemura, Toshihiko; Tokimasa, Noritaka; Narumi, Yasunori

2005-06-01

This is the second report on Mars in 2003 by two networks for cooperative Mars observations in Japan: Nishi-Harima Astronomical Observatory Mars Cooperative Observation and Association of Lunar and Planetary Observers in Japan. This paper is a summary of 4145 data for 226 nights collected by the two networks during the second half of the last apparition from 2003 September 1 through 2004 June 22, corresponding to a period of Ls ˜ 252°--51° (Ls is the areocentric longitude of the Sun). During this period, many interesting phenomena were observed: (1) Albedo features did not show a large difference from the first half of the period. (2) Blue clearings due to the opposition effect and due to the cloud effect were, respectively, observed. (3) South polar cap (SPC) recession was usual. The recession rate in ˜ 210°--270°W increased and that in ˜ 30°--60°W decreased after Ls ˜ 230°. (4) North polar hood (NPH) had a topography-synchronous wave structure with a wave number = 1. (5) Many water ice clouds (WICs) were observed. Some particular regions frequently had prominent WICs. Some of them were related to topography. (6) Dust storm ``2003c'' was detected on December 9 (Ls = 314°) in Chryse. The storm grew rapidly to a very large dimension in the southern mid-latitudes, encircling over half of Mars. Another dust core occurred on December 23 around Aurorae Sinus. (7) Another dust storm is suspected in Ls = 20° over the south polar region.

Teacher Observation: Evaluation Report and Executive Summary

ERIC Educational Resources Information Center

Worth, Jack; Sizmur, Juliet; Walker, Matthew; Bradshaw, Sally; Styles, Ben

2017-01-01

The Teacher Observation intervention aimed to improve teacher effectiveness through structured peer observation. Teachers observe and are observed by their peers a number of times over the course of two years. It was delivered by the Centre for Market and Public Organisation (CMPO) at the University of Bristol. CMPO researchers trained lead…

Observational studies using propensity score analysis underestimated the effect sizes in critical care medicine.

PubMed

Zhang, Zhongheng; Ni, Hongying; Xu, Xiao

2014-08-01

Propensity score (PS) analysis has been increasingly used in critical care medicine; however, its validation has not been systematically investigated. The present study aimed to compare effect sizes in PS-based observational studies vs. randomized controlled trials (RCTs) (or meta-analysis of RCTs). Critical care observational studies using PS were systematically searched in PubMed from inception to April 2013. Identified PS-based studies were matched to one or more RCTs in terms of population, intervention, comparison, and outcome. The effect sizes of experimental treatments were compared for PS-based studies vs. RCTs (or meta-analysis of RCTs) with sign test. Furthermore, ratio of odds ratio (ROR) was calculated from the interaction term of treatment × study type in a logistic regression model. A ROR < 1 indicates greater benefit for experimental treatment in RCTs compared with PS-based studies. RORs of each comparison were pooled by using meta-analytic approach with random-effects model. A total of 20 PS-based studies were identified and matched to RCTs. Twelve of the 20 comparisons showed greater beneficial effect for experimental treatment in RCTs than that in PS-based studies (sign test P = 0.503). The difference was statistically significant in four comparisons. ROR can be calculated from 13 comparisons, of which four showed significantly greater beneficial effect for experimental treatment in RCTs. The pooled ROR was 0.71 (95% CI: 0.63, 0.79; P = 0.002), suggesting that RCTs (or meta-analysis of RCTs) were more likely to report beneficial effect for the experimental treatment than PS-based studies. The result remained unchanged in sensitivity analysis and meta-regression. In critical care literature, PS-based observational study is likely to report less beneficial effect of experimental treatment compared with RCTs (or meta-analysis of RCTs). Copyright © 2014 Elsevier Inc. All rights reserved.

Distracted Biking: An Observational Study.

PubMed

Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J

2016-01-01

Commuting via bicycle is a very popular mode of transportation in the Northeastern United States. Boston, MA, has seen a rapid increase in bicycle ridership over the past decade, which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at 4 high traffic intersections in Boston during various peak commuting hours for 2 types of distractions: auditory (earbuds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%), 95% CI [29, 33%], were distracted. Of those observed, auditory distractions were the most common (N = 349; 17.7%), 95% CI [16, 19], p = .0003, followed by visual/tactile distractions (N = 266; 13.5%), 95% CI [12, 15]. The highest proportion (40.7%), 95% CI [35, 46], of distracted bicyclists was observed during the midday commute (between 13:30 and 15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost a third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured.

Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies.

PubMed

Lee, Aeyoung; Myung, Seung Kwon; Cho, Jung Jin; Jung, Yu Jin; Yoon, Jong Lull; Kim, Mee Young

2017-07-01

This study aimed to assess whether night shift work is associated with the risk of depression by using a meta-analysis of observational studies. We searched PubMed and EMBASE in August, 2016 to locate eligible studies and investigated the association between night shift work and the risk of depression, reporting outcome measures with adjusted odds ratios (ORs) or relative risks (RRs) and 95% confidence intervals (CIs). In the meta-analysis of a total of 11 observational studies with 9 cross-sectional study, 1 longitudinal study, and 1 cohort study, night shift work was significantly associated with an increased risk of depression (OR/RR, 1.43; 95% CI, 1.24-1.64; I² = 78.0%). Also, subgroup meta-analyses by gender, night shift work duration, type of occupation, continent, and type of publication showed that night shift work was consistently associated with the increased risk of depression. The current meta-analysis suggests that night shift work is associated with the increased risk of depression. However, further large prospective cohort studies are needed to confirm this association. © 2017 The Korean Academy of Medical Sciences.

An observation tool to study air traffic control and flightdeck collaboration.

PubMed

Cox, Gemma; Sharples, Sarah; Stedmon, Alex; Wilson, John

2007-07-01

The complex systems of the flightdeck (FD) and the Air Traffic Control Centre (ATC) are characterised by numerous concurrently operating and interacting communication channels between people and between people and machines/computer systems. This paper describes work in support of investigating the impact of changes to technologies and responsibilities within this system with respect to human factors. It focuses primarily on the introduction of datalink (text-based communication rather than traditional radio communication) and the move towards freeflight (pilot-mediated air traffic control). Air traffic management investigations have outlined these specific changes as strategies to enable further increases in the volume of air traffic. A systems approach was taken and field studies were conducted. Small numbers of domain experts such as air traffic controllers (ATCOs) were involved in the field-based observations of how people interact with systems and each other. This paper summarises the overall research approach taken and then specifically reports on the field-based observations including the justification, development, and findings of the observation tool used. The observation tool examined information propagation through the air traffic control-flightdeck (ATC-FD) system, and resulted in models of possible information trajectories through the system.

Validity of self-reported cancer history in the health examinees (HEXA) study: A comparison of self-report and cancer registry records.

PubMed

Cho, Sooyoung; Shin, Aesun; Song, Daesub; Park, Jae Kyung; Kim, Yeonjung; Choi, Ji-Yeob; Kang, Daehee; Lee, Jong-Koo

2017-10-01

To assess the validity of the cohort study participants' self-reported cancer history via data linkage to a cancer registry database. We included 143,965 participants from the Health Examinees (HEXA) study recruited between 2004 and 2013 who gave informed consent for record linkage to the Korean Central Cancer Registry (KCCR). The sensitivity and the positive predictive value of self-reported histories of cancer were calculated and 95% confidence intervals were estimated. A total of 4,860 participants who had at least one record in the KCCR were included in the calculation of sensitivity. In addition, 3,671 participants who reported a cancer history at enrollment were included in the calculation of positive predictive value. The overall sensitivity of self-reported cancer history was 72.0%. Breast cancer history among women showed the highest sensitivity (81.2%), whereas the lowest sensitivity was observed for liver cancer (53.7%) and cervical cancer (52.1%). The overall positive predictive value was 81.9%. The highest positive predictive value was observed for thyroid cancer (96.1%) and prostate cancer (96.1%), and the lowest was observed for cervical cancer (43.7%). The accuracy of self-reported cancer history varied by cancer site and may not be sufficient to ascertain cancer incidence, especially for cervical and bladder cancers. Copyright © 2017. Published by Elsevier Ltd.

A Numerical Climate Observing Network Design Study

NASA Technical Reports Server (NTRS)

Stammer, Detlef

2003-01-01

This project was concerned with three related questions of an optimal design of a climate observing system: 1. The spatial sampling characteristics required from an ARGO system. 2. The degree to which surface observations from ARGO can be used to calibrate and test satellite remote sensing observations of sea surface salinity (SSS) as it is anticipated now. 3. The more general design of an climate observing system as it is required in the near future for CLIVAR in the Atlantic. An important question in implementing an observing system is that of the sampling density required to observe climate-related variations in the ocean. For that purpose this project was concerned with the sampling requirements for the ARGO float system, but investigated also other elements of a climate observing system. As part of this project we studied the horizontal and vertical sampling characteristics of a global ARGO system which is required to make it fully complementary to altimeter data with the goal to capture climate related variations on large spatial scales (less thanAttachment: 1000 km). We addressed this question in the framework of a numerical model study in the North Atlantic with an 1/6 horizontal resolution. The advantage of a numerical design study is the knowledge of the full model state. Sampled by a synthetic float array, model results will therefore allow to test and improve existing deployment strategies with the goal to make the system as optimal and cost-efficient as possible. Attachment: "Optimal observations for variational data assimilation".

Improving visual observation skills through the arts to aid radiographic interpretation in veterinary practice: A pilot study.

PubMed

Beck, Cathy; Gaunt, Heather; Chiavaroli, Neville

2017-09-01

Radiographic interpretation is a perceptual and cognitive skill. Recently core veterinary radiology textbooks have focused on the cognitive (i.e., the clinical aspects of radiographic interpretation) rather than the features of visual observation that improve identification of abnormalities. As a result, the skill of visual observation is underemphasized and thus often underdeveloped by trainees. The study of the arts in medical education has been used to train and improve visual observation and empathy. The use of the arts to improve visual observation skills in Veterinary Science has not been previously described. Objectives of this pilot study were to adapt the existing Visual Arts in Health Education Program for medical and dental students at the University of Melbourne, Australia to third year Doctor of Veterinary Medicine students and evaluate their perceptions regarding the program's effects on visual observation skills and confidence with respect to radiographic interpretation. This adaptation took the form of a single seminar given to third year Doctor of Veterinary Medicine students. Following the seminar, students reported an improved approach to radiographic interpretation and felt they had gained skills which would assist them throughout their career. In the year following the seminar, written reports of the students who attended the seminar were compared with reports from a matched cohort of students who did not attend the seminar. This demonstrated increased identification of abnormalities and greater description of the abnormalities identified. Findings indicated that explicit training in visual observation may be a valuable adjunct to the radiology training of Doctor of Veterinary Medicine students. © 2017 American College of Veterinary Radiology.

The utility of observational studies in clinical decision making: lessons learned from statin trials.

PubMed

Foody, JoAnne M; Mendys, Phillip M; Liu, Larry Z; Simpson, Ross J

2010-05-01

Contemporary clinical decision making is well supported by a wide variety of information sources, including clinical practice guidelines, position papers, and insights from randomized controlled trials (RCTs). Much of our fundamental understanding of cardiovascular risk factors is based on multiple observations from major epidemiologic studies, such as The Seven Country Studies and the US-based Framingham Heart Study. These studies provided the framework for the development of clinical practice guidelines, including the National Cholesterol Education Program Adult Treatment Panel series. The objective of this article is to highlight the value of observational studies as a complement to clinical trial data for clinical decision making in real-world practice. Although RCTs are still the benchmark for assessing clinical efficacy and safety of a specific therapeutic approach, they may be of limited utility to practitioners who must then adapt the lessons learned from the trial into the patient care environment. The use of well-structured observational studies can improve our understanding of the translation of clinical trials into clinical practice, as demonstrated here with the example of statins. Although such studies have their own limitations, improved techniques for design and analysis have reduced the impact of bias and confounders. The introduction of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines has provided more uniformity for such studies. When used together with RCTs, observational studies can enhance our understanding of effectiveness and utility in real-world clinical practice. In the examples of statin observational studies, the results suggest that relative effectiveness of different statins and potential impact of switching statins should be carefully considered in treating individual patients by practicing physicians.

Innovation and the burden of disease: retrospective observational study of new and emerging health technologies reported by the EuroScan Network from 2000 to 2009.

PubMed

Martino, Orsolina I; Ward, Derek J; Packer, Claire; Simpson, Sue; Stevens, Andrew

2012-01-01

Medical innovation in developed countries has been linked to burden of disease, with more innovation in areas representing greater investment return. This study used horizon scanning or early awareness and alert activity as a novel measure of innovation to determine whether new and emerging health technologies reported by international horizon scanning agencies reflected diseases constituting the greatest burden. This was a retrospective observational study of the 20 member agencies of EuroScan (the International Information Network on New and Emerging Health Technologies), representing 17 developed countries. Burden of disease was defined as disability-adjusted life-years, taken from the 2004 World Health Organization Global Burden of Disease estimates. This analysis focused on 102 specific diseases within 21 broader groups. Horizon scanning output was measured as the number of technologies reported by EuroScan member agencies between 2000 and 2009. At best there was a weak association between innovation and burden of disease. An apparent high-level association was dependent on just three high-prevalence disease groups: malignant neoplasms, neuropsychiatric conditions, and cardiovascular disease. Disaggregating broader groups into specific diseases further weakened the association. Innovation is disproportionately strong in cancer and nonischemic heart disease and disproportionately weak in mental health. Innovations reported by early awareness and alert systems do not always reflect conditions accounting for the highest morbidity and mortality. The results do not support previous reports of a positive relationship between burden of disease and innovation, but accord with evidence of notable discrepancies among key groups. Factors other than disease burden drive innovation. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Body Mass Index, Sex, Interview Protocol, and Children’s Accuracy for Reporting Kilocalories Observed Eaten at School Meals

PubMed Central

Baxter, Suzanne Domel; Smith, Albert F.; Litaker, Mark S.; Guinn, Caroline H.; Nichols, Michele D.; Miller, Patricia H.; Kipp, Katherine

2008-01-01

This pilot study investigated body mass index (BMI), sex, interview protocol, and children’s accuracy for reporting kilocalories. Forty fourth-grade children (20 low BMI [LBMI; ≥5th and <50th percentiles; 10 boys; 15 black], 20 high BMI [HBMI;≥ 85th percentile; 10 boys; 15 black]) were observed eating school meals (breakfast, lunch) and interviewed either that evening about the prior 24 hours (24E) or the next morning about the previous day (PDM), with 10 LBMI (5 boys) and 10 HBMI (5 boys) per interview protocol. Five kilocalorie variables were analyzed using separate 4-factor (BMI group, sex, race, interview protocol) analyses of variance. No effects were found for reported or matched kilocalories. More kilocalories were observed (p<0.02) and omitted (p<0.05) by HBMI than LBMI children. For intruded kilocalories, means were smaller (better) for HBMI girls than HBMI boys, but larger for LBMI girls than LBMI boys (interaction p<0.04); LBMI girls intruded the most while HBMI girls intruded the least. For interview protocol, omitted and intruded kilocalories were higher (worse), although not significantly so (ps<0.11), for PDM than 24E. These results illuminate relations of BMI, sex, interview protocol, and children’s reporting accuracy, and are consistent with results concerning BMI and sex from studies with adults. PMID:17000199

Alcohol Intake and Risk of Thyroid Cancer: A Meta-Analysis of Observational Studies.

PubMed

Hong, Seung-Hee; Myung, Seung-Kwon; Kim, Hyeon Suk

2017-04-01

The purpose of this study was to assess whether alcohol intake is associated with the risk of thyroid cancer by a meta-analysis of observational studies. We searched PubMed and EMBASE in June of 2015 to locate eligible studies. We included observational studies such as cross-sectional studies, case-control studies, and cohort studies reporting odd ratios (ORs) or relative risk (RRs) with 95% confidence intervals (CIs). We included 33 observational studies with two cross-sectional studies, 20 case-controls studies, and 11 cohort studies, which involved a total of 7,725 thyroid cancer patients and 3,113,679 participants without thyroid cancer in the final analysis. In the fixed-effect model meta-analysis of all 33 studies, we found that alcohol intake was consistently associated with a decreased risk of thyroid cancer (OR or RR, 0.74; 95% CI, 0.67 to 0.83; I 2 =38.6%). In the subgroup meta-analysis by type of study, alcohol intake also decreased the risk of thyroid cancer in both case-control studies (OR, 0.77; 95% CI, 0.65 to 0.92; I 2 =29.5%; n=20) and cohort studies (RR, 0.70; 95% CI, 0.60 to 0.82; I 2 =0%; n=11). Moreover, subgroup meta-analyses by type of thyroid cancer, gender, amount of alcohol consumed, and methodological quality of study showed that alcohol intake was significantly associated with a decreased risk of thyroid cancer. The current meta-analysis of observational studies found that, unlike most of other types of cancer, alcohol intake decreased the risk of thyroid cancer.

Alcohol Intake and Risk of Thyroid Cancer: A Meta-Analysis of Observational Studies

PubMed Central

Hong, Seung-Hee; Myung, Seung-Kwon; Kim, Hyeon Suk

2017-01-01

Purpose The purpose of this study was to assess whether alcohol intake is associated with the risk of thyroid cancer by a meta-analysis of observational studies. Materials and Methods We searched PubMed and EMBASE in June of 2015 to locate eligible studies. We included observational studies such as cross-sectional studies, case-control studies, and cohort studies reporting odd ratios (ORs) or relative risk (RRs) with 95% confidence intervals (CIs). Results We included 33 observational studies with two cross-sectional studies, 20 case-controls studies, and 11 cohort studies, which involved a total of 7,725 thyroid cancer patients and 3,113,679 participants without thyroid cancer in the final analysis. In the fixed-effect model meta-analysis of all 33 studies, we found that alcohol intake was consistently associated with a decreased risk of thyroid cancer (OR or RR, 0.74; 95% CI, 0.67 to 0.83; I2=38.6%). In the subgroup meta-analysis by type of study, alcohol intake also decreased the risk of thyroid cancer in both case-control studies (OR, 0.77; 95% CI, 0.65 to 0.92; I2=29.5%; n=20) and cohort studies (RR, 0.70; 95% CI, 0.60 to 0.82; I2=0%; n=11). Moreover, subgroup meta-analyses by type of thyroid cancer, gender, amount of alcohol consumed, and methodological quality of study showed that alcohol intake was significantly associated with a decreased risk of thyroid cancer. Conclusion The current meta-analysis of observational studies found that, unlike most of other types of cancer, alcohol intake decreased the risk of thyroid cancer. PMID:27456949

Field trip report: Observations made at Yucca Mountain, Nye County, Nevada. Special report No. 2

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

Hill, C.A.

1993-03-01

A field trip was made to the Yucca Mountain area on December 5-9, 1992 by Jerry Frazier, Don Livingston, Christine Schluter, Russell Harmon, and Carol Hill. Forty-three separate stops were made and 275 lbs. of rocks were collected during the five days of the field trip. Key localities visited were the Bare Mountains, Yucca Mountain, Calico Hills, Busted Butte, Harper Valley, Red Cliff Gulch, Wahmonie Hills, Crater Flat, and Lathrop Wells Cone. This report only describes field observations made by Carol Hill. Drawings are used rather than photographs because cameras were not permitted on the Nevada Test Site during thismore » trip.« less

Risk Aversion and Public Reporting. Part 1: Observations From Cardiac Surgery and Interventional Cardiology.

PubMed

Shahian, David M; Jacobs, Jeffrey P; Badhwar, Vinay; D'Agostino, Richard S; Bavaria, Joseph E; Prager, Richard L

2017-12-01

Risk aversion is a potential unintended consequence of health care public reporting. In Part 1 of this review, four possible consequences of this phenomenon are discussed, including the denial of interventions to some high-risk patients, stifling of innovation, appropriate avoidance of futile interventions, and better matching of high-risk patients to more capable providers. We also summarize relevant observational clinical reports and survey results from cardiovascular medicine and surgery, the two specialties from which almost all risk aversion observations have been derived. Although these demonstrate that risk aversion does occur, the empirical data are much more consistent and compelling for interventional cardiology than for cardiac surgery. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Prospective study of recovery from copperhead snake envenomation: an observational study.

PubMed

Lavonas, Eric J; Gerardo, Charles J

2015-05-15

Although much is known about signs, symptoms, and management in the acute phase of crotaline snake envenomation, little is known about signs, symptoms, function, and quality of life during the recovery phase. The purpose of this observational pilot investigation is to evaluate the utility of several clinical outcome instruments in the setting of copperhead snakebite, and to characterize the clinical course of recovery. This is a multi-center prospective, open-label, observational study of patients envenomated by copperhead snakes. We administered the Disabilities of the Arm, Shoulder, and Hand (DASH), Lower Extremity Functional Scale (LEFS), Patient-Specific Functional Scale (PSFS), Work Productivity and Ability Impairment: Special Health Problem (WPAI: SHP), Patients' Global Impression of Change (PGIC), Patient's Global Assessment of Recovery (PGAR), and SF-36 instruments, obtained numeric pain rating scales, and measured grip strength, walking speed, and swelling prior to hospital discharge and 3, 7, 14, 21, and 28 days after envenomation. 20 subjects were enrolled; none were lost to follow-up. Most (80%) had moderate severity swelling, and most (75%) received antivenom. Across the broad range of measures, abnormalities of pain, swelling, impairments of physical and role function, and quality of life persisted for 7-14 days in most subjects. Validated self-reported outcome measures, such as the DASH, LEFS, PSFS, PGIC, SF-36, and the daily activities impairment portion of the WPAI: SHP were more responsive than measurements of swelling or walking speed. Data quality issues limited the utility of the work impairment portion of the WPAI: SHP. Residual signs, symptoms, and impairment in some subjects lasted through the 28-day study period. The study design precluded any assessment of the effectiveness of antivenom. Signs, symptoms, impaired function, and decreased quality of life typically last 7 - 14 days after copperhead envenomation. Several tools appear

Reflective Practice through Journal Writing and Peer Observation: A Case Study

ERIC Educational Resources Information Center

Lakshmi, B. Samrajya

2014-01-01

Journal writing and Peer Observation in an educational context have become popular techniques, with several different types of applications. They have now been used quite widely in both language teaching and in teacher training. However, despite its reported advantages in both teaching and research, there are not many Peer Observation and Diary…

Relationships Between Self-Reported and Observed Parenting Behaviour, Adolescent Disordered Eating Attitudes and Behaviours, and the 5-HTTLPR Polymorphism: Data From the Australian Temperament Project.

PubMed

Rozenblat, Vanja; Ryan, Joanne; Wertheim, Eleanor; King, Ross; Olsson, Craig A; Letcher, Primrose; Krug, Isabel

2017-09-01

This study examined whether self-reported and observationally measured parental behaviours were associated with disordered eating, and investigated possible moderation by a serotonin-transporter polymorphism (5-HTTLPR). Study 1 included 650 adolescents from the Australian Temperament Project who completed the Eating Disorder Inventory-2 Drive for Thinness and Bulimia scales at 15/16 years and were genotyped for 5-HTTLPR. Parents completed an Australian Temperament Project-devised measure of parental warmth and harsh punishment. Study 2 included a subgroup of 304 participants who also engaged in a video-recorded family interaction, with observed parental warmth and hostility coded by the Iowa Family Interaction Rating Scale. Greater self-reported parental warmth was associated with lower bulimia scores. Conversely, observationally measured parental warmth was associated with lower drive for thinness, but not bulimia. Self-reported parental harsh punishment was associated with bulimia only, with observed parental hostility associated with neither outcome. 5-HTTLPR genotype did not moderate the relationship between parent behaviours and adolescent disordered eating. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

Perspective: An Extension of the STROBE Statement for Observational Studies in Nutritional Epidemiology (STROBE-nut): Explanation and Elaboration

PubMed Central

Berg, Christina; Forsum, Elisabet; Larsson, Christel; Sonestedt, Emily; Åkesson, Agneta; Lachat, Carl; Hawwash, Dana; Kolsteren, Patrick; Byrnes, Graham; De Keyzer, Willem; Van Camp, John; Cade, Janet E; Greenwood, Darren C; Slimani, Nadia; Cevallos, Myriam; Egger, Matthias; Huybrechts, Inge; Wirfält, Elisabet

2017-01-01

Nutritional epidemiology is an inherently complex and multifaceted research area. Dietary intake is a complex exposure and is challenging to describe and assess, and links between diet, health, and disease are difficult to ascertain. Consequently, adequate reporting is necessary to facilitate comprehension, interpretation, and generalizability of results and conclusions. The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement is an international and collaborative initiative aiming to enhance the quality of reporting of observational studies. We previously presented a checklist of 24 reporting recommendations for the field of nutritional epidemiology, called “the STROBE-nut.” The STROBE-nut is an extension of the general STROBE statement, intended to complement the STROBE recommendations to improve and standardize the reporting in nutritional epidemiology. The aim of the present article is to explain the rationale for, and elaborate on, the STROBE-nut recommendations to enhance the clarity and to facilitate the understanding of the guidelines. Examples from the published literature are used as illustrations, and references are provided for further reading. PMID:28916567

Parturient perineal distensibility tolerance assessed by EPI-NO: an observational study

PubMed Central

Nakamura, Mary Uchiyama; Sass, Nelson; Elito, Julio; Petricelli, Carla Dellabarba; Alexandre, Sandra Maria; Araujo, Edward; Zanetti, Miriam Raquel Diniz

2014-01-01

ABSTRACT Objective: To determine how parturient women tolerate the use of a perineal distensibility assessment technique using the EPI-NO device. Methods: An observational study with a total of 227 full-term parturient women was performed. During the evaluation with EPI-NO, parturient patients were asked about their sensation of discomfort. The degree of discomfort was measured using the Visual Analogue Scale, with a score from zero to 10. The Mann-Whitney test was applied to assess perineal distensibility measured by EPI-NO and the degree of discomfort caused by the test according to parity. The relation between perineal distensibility and discomfort was analyzed by using the Spearman correlation test (r). Results: The test with EPI-NO caused only slight discomfort (mean Visual Analogue Scale of 3.8), and primiparous women reported significantly greater discomfort (mean Visual Analogue Scale of 4.5) than did multiparous (mean Visual Analogue Scale=3.1), with p<0.001 women. A negative correlation was observed, in other words, the greater the perineal distensibility on the EPI-NO, the lower the pain reported by the patients (r=-0.424; p<0.001). Conclusion: The assessment of perineal distensibility with EPI-NO was well tolerated by the parturient women. PMID:24728241

Distracted Biking: An Observational Study

PubMed Central

Wolfe, Elizabeth Suzanne; Arabian, Sandra Strack; Breeze, Janis L; Salzler, Matthew J.

2016-01-01

Commuting via bicycle is a very popular mode of transportation in the Northeastern United States (US). Boston, MA has seen a rapid increase in bicycle ridership over the past decade which has raised concerns and awareness about bicycle safety. An emerging topic in this field is distracted bicycle riding. This study was conducted to provide descriptive data on the prevalence and type of distracted bicycling in Boston at different times of day. This was a cross-sectional study in which observers tallied bicyclists at four high traffic intersections in Boston during various peak commuting hours for two types of distractions: auditory (ear buds/phones in or on ears), and visual/tactile (electronic device or other object in hand). Nineteen hundred seventy-four bicyclists were observed and 615 (31.2%, 95% CI: 29%-33%) were distracted. Of those observed, auditory distractions were the most common (N= 349 [17.7%, 95% CI: 16%-19%], p=0.0003) followed by visual/tactile distractions (N= 266 [13.5%, 95% CI: 12%-15%]). The highest proportion (40.7%, 95% CI: 35%-46%) of distracted bicyclists was observed during the midday commute (between 13:30-15:00). Distracted bicycling is a prevalent safety concern in the city of Boston, as almost one-third of all bicyclists exhibited distracted behavior. Education and public awareness campaigns should be designed to decrease distracted bicycling behaviors and promote bicycle safety in Boston. An awareness of the prevalence of distracted biking can be utilized to promote bicycle safety campaigns dedicated to decreasing distracted bicycling and to provide a baseline against which improvements can be measured. PMID:26953533

Quality of Parent-Adolescent Conversations about Sex and Adolescent Sexual Behavior: An Observational Study

PubMed Central

Rogers, Adam A.; Ha, Thao; Stormshak, Elizabeth A.; Dishion, Thomas J.

2015-01-01

PURPOSE Studies suggest that the quality of parent-adolescent communication about sex uniquely predicts adolescent sexual behavior. Previous studies have relied predominantly on self-report data. Observational methods, which are not susceptible to self-report biases, may be useful in examining the associations between the quality of parent-adolescent communication about sex and adolescent sexual behavior more objectively. METHOD With a sample of adolescents (N = 55, 58% male, 44% White, Mage = 15.8) and their parents, we used hierarchical logistic regression analyses to examine the associations between the observed quality of parent-adolescent communication about dating and sex and the likelihood of adolescents’ sexual intercourse. RESULTS The quality of parent-adolescent communication about dating and sex predicted sexual behavior. Specifically, lecturing was associated with a higher likelihood of adolescents having had sexual intercourse. CONCLUSIONS The quality of parent-adolescent communication about sex is a unique correlate of adolescent sexual behavior and warrants further investigation. Thus, it serves as a potential target of preventive interventions that aim to foster adolescent sexual health behaviors. PMID:26206438

Links of adolescent- and parent-reported eating in the absence of hunger with observed eating in the absence of hunger.

PubMed

Shomaker, Lauren B; Tanofsky-Kraff, Marian; Mooreville, Mira; Reina, Samantha A; Courville, Amber B; Field, Sara E; Matheson, Brittany E; Brady, Sheila M; Yanovski, Susan Z; Yanovski, Jack A

2013-06-01

Eating in the absence of hunger (EAH) typically was assessed by measuring snack intake after consumption of a meal. There were no validated self-report measures of EAH. The relationship of adolescent self-report and parent-reported EAH to adolescents' measured intake in the absence of hunger was examined. Ninety adolescents completed the Eating in the Absence of Hunger Questionnaire for Children and Adolescents (EAH-C) to describe eating when not hungry. Parents described children's EAH on a parallel version designed for parents (EAH-P). In a randomized crossover study, adolescent EAH in response to external cues was measured as snack intake after a lunch meal standardized to provide 50% of daily energy requirements and after a large array (>10,000 kcal). Parents' reports of children's EAH in response to external cues were associated with greater EAH after both meals, adjusting for body composition, sex, age, race, puberty, and meal intake. Adolescent-reported EAH was unrelated or showed an inverse association with observed EAH. Parent-reported EAH showed a positive association with adolescents' observed EAH and may be a useful research and clinical tool for assessing EAH in response to external cues in conditions when laboratory assessments are not feasible. Copyright © 2012 The Obesity Society.

Ayahuasca-assisted therapy for addiction: results from a preliminary observational study in Canada.

PubMed

Thomas, Gerald; Lucas, Philippe; Capler, N Rielle; Tupper, Kenneth W; Martin, Gina

2013-03-01

This paper reports results from a preliminary observational study of ayahuasca-assisted treatment for problematic substance use and stress delivered in a rural First Nations community in British Columbia, Canada. The "Working with Addiction and Stress" retreats combined four days of group counselling with two expert-led ayahuasca ceremonies. This study collected pre-treatment and six months follow-up data from 12 participants on several psychological and behavioral factors related to problematic substance use, and qualitative data assessing the personal experiences of the participants six months after the retreat. Statistically significant (p < 0.05) improvements were demonstrated for scales assessing hopefulness, empowerment, mindfulness, and quality of life meaning and outlook subscales. Self-reported alcohol, tobacco and cocaine use declined, although cannabis and opiate use did not; reported reductions in problematic cocaine use were statistically significant. All study participants reported positive and lasting changes from participating in the retreats. This form of ayahuasca-assisted therapy appears to be associated with statistically significant improvements in several factors related to problematic substance use among a rural aboriginal population. These findings suggest participants may have experienced positive psychological and behavioral changes in response to this therapeutic approach, and that more rigorous research of ayahuasca-assisted therapy for problematic substance use is warranted.

Quality standards for real-world research. Focus on observational database studies of comparative effectiveness.

PubMed

Roche, Nicolas; Reddel, Helen; Martin, Richard; Brusselle, Guy; Papi, Alberto; Thomas, Mike; Postma, Dirjke; Thomas, Vicky; Rand, Cynthia; Chisholm, Alison; Price, David

2014-02-01

Real-world research can use observational or clinical trial designs, in both cases putting emphasis on high external validity, to complement the classical efficacy randomized controlled trials (RCTs) with high internal validity. Real-world research is made necessary by the variety of factors that can play an important a role in modulating effectiveness in real life but are often tightly controlled in RCTs, such as comorbidities and concomitant treatments, adherence, inhalation technique, access to care, strength of doctor-caregiver communication, and socio-economic and other organizational factors. Real-world studies belong to two main categories: pragmatic trials and observational studies, which can be prospective or retrospective. Focusing on comparative database observational studies, the process aimed at ensuring high-quality research can be divided into three parts: preparation of research, analyses and reporting, and discussion of results. Key points include a priori planning of data collection and analyses, identification of appropriate database(s), proper outcomes definition, study registration with commitment to publish, bias minimization through matching and adjustment processes accounting for potential confounders, and sensitivity analyses testing the robustness of results. When these conditions are met, observational database studies can reach a sufficient level of evidence to help create guidelines (i.e., clinical and regulatory decision-making).

Rapid sequence induction of anaesthesia via the intraosseous route: a prospective observational study.

PubMed

Barnard, E B G; Moy, R J; Kehoe, A D; Bebarta, V S; Smith, J E

2015-06-01

Intraosseous (IO) drug infusion has been reported to have similar pharmacokinetics to intravenous (IV) infusion. In military and civilian trauma, the IO route is often used to obtain rapid and reliable parenteral access for drug administration. Only a few case reports have described the use of IO infusion to administer drugs for rapid sequence induction of anaesthesia (RSI). We aimed to assess the feasibility of the administration of RSI drugs via an IO catheter in a prospective observational study. A prospective observational study was undertaken at a combat hospital in Afghanistan. A validated data form was used to record the use of IO drugs for RSI by the prehospital, physician-led Medical Emergency Response Team (MERT), and by inhospital physicians. Data were captured between January and May 2012 by interview with MERT physicians and inhospital physicians directly after RSI. The primary outcome measure was the success rate of first-pass intubation with direct laryngoscopy. 34 trauma patients (29 MERT and 5 inhospital) underwent RSI with IO drug administration. The median age was 24 years and median injury severity score 25; all were male. The predominant mechanism of injury was blast (n=24), followed by penetrating (n=6), blunt (n=3) and burn (n=1). First-pass intubation success rate was 97% (95% CI 91% to 100%). A Cormack-Lehane grade 1 view, by direct laryngoscopy, was obtained at first look in 91% (95% CI 81% to 100%) of patients. In this prospective, observational study, IO drug administration was successfully used for trauma RSI, with a comparable first pass intubation success than published studies describing the IV route. RCDM/Res/Audit/1036/12/0162. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials.

PubMed

Anglemyer, Andrew; Horvath, Hacsi T; Bero, Lisa

2014-04-29

. Comparisons included RCTs versus observational studies (including retrospective cohorts, prospective cohorts, case-control designs, and cross-sectional designs). Reviews were not eligible if they compared randomized trials with other studies that had used some form of concurrent allocation. In general, outcome measures included relative risks or rate ratios (RR), odds ratios (OR), hazard ratios (HR). Using results from observational studies as the reference group, we examined the published estimates to see whether there was a relative larger or smaller effect in the ratio of odds ratios (ROR).Within each identified review, if an estimate comparing results from observational studies with RCTs was not provided, we pooled the estimates for observational studies and RCTs. Then, we estimated the ratio of ratios (risk ratio or odds ratio) for each identified review using observational studies as the reference category. Across all reviews, we synthesized these ratios to get a pooled ROR comparing results from RCTs with results from observational studies. Our initial search yielded 4406 unique references. Fifteen reviews met our inclusion criteria; 14 of which were included in the quantitative analysis.The included reviews analyzed data from 1583 meta-analyses that covered 228 different medical conditions. The mean number of included studies per paper was 178 (range 19 to 530).Eleven (73%) reviews had low risk of bias for explicit criteria for study selection, nine (60%) were low risk of bias for investigators' agreement for study selection, five (33%) included a complete sample of studies, seven (47%) assessed the risk of bias of their included studies,Seven (47%) reviews controlled for methodological differences between studies,Eight (53%) reviews controlled for heterogeneity among studies, nine (60%) analyzed similar outcome measures, and four (27%) were judged to be at low risk of reporting bias.Our primary quantitative analysis, including 14 reviews, showed that the pooled ROR comparing

Identifying key components for an effective case report poster: an observational study.

PubMed

Willett, Lisa L; Paranjape, Anuradha; Estrada, Carlos

2009-03-01

Residents demonstrate scholarly activity by presenting posters at academic meetings. Although recommendations from national organizations are available, evidence identifying which components are most important is not. To develop and test an evaluation tool to measure the quality of case report posters and identify the specific components most in need of improvement. Faculty evaluators reviewed case report posters and provided on-site feedback to presenters at poster sessions of four annual academic general internal medicine meetings. A newly developed ten-item evaluation form measured poster quality for specific components of content, discussion, and format (5-point Likert scale, 1 = lowest, 5 = highest). Evaluation tool performance, including Cronbach alpha and inter-rater reliability, overall poster scores, differences across meetings and evaluators and specific components of the posters most in need of improvement. Forty-five evaluators from 20 medical institutions reviewed 347 posters. Cronbach's alpha of the evaluation form was 0.84 and inter-rater reliability, Spearman's rho 0.49 (p < 0.001). The median score was 4.1 (Q1 -Q3, 3.7-4.6)(Q1 = 25th, Q3 = 75th percentile). The national meeting median score was higher than the regional meetings (4.4 vs, 4.0, P < 0.001). We found no difference in faculty scores. The following areas were identified as most needing improvement: clearly state learning objectives, tie conclusions to learning objectives, and use appropriate amount of words. Our evaluation tool provides empirical data to guide trainees as they prepare posters for presentation which may improve poster quality and enhance their scholarly productivity.

Consolidated RXTE Observing Grants on Observation of Neutron Stars and Black Holes in Binaries

NASA Technical Reports Server (NTRS)

Prince, Thomas A.; Vaughan, Brian A.

1998-01-01

This final report is a study of neutron stars and black holes in binaries. The activities focused on observation made with the Rossi X-ray Timing Explorer. The following areas were covered: long term observations of accreting binary pulsars with the All-Sky Monitor (ASM); observations of Centaurus X-3 with the Proportional Counter Array (PCA) and the High-Energy X-ray Timing Experiment (HEXTE); observations of accreting pulsars with the PCA and HEXTE; studies of quasi-periodic oscillations (QPO); and investigations of accreting black-hole candidates.

The development and validation of the Dormitory Observation Report: a behavioral rating instrument for juvenile delinquents in residential care.

PubMed

Veneziano, Louis; Veneziano, Carol

2002-09-01

In order to provide an objective measure of problematic behavioral patterns among juvenile delinquents in residential facilities, the Dormitory Observation Report (DOR) was developed. The DOR assesses 11 dimensions of problematic behavioral patterns (e.g., physical assaultiveness, manipulativeness), as well as three dimensions of desirable behavioral patterns expected in an institutional setting (e.g., independent functioning, personal hygiene, care of surroundings). Empirical study regarding the reliability and validity of the DOR are reported, and the results are discussed in terms of the theoretical and practical implications of this instrument. Copyright 2002 Wiley Periodicals, Inc.

Neural reactivity to monetary rewards and losses in childhood: longitudinal and concurrent associations with observed and self-reported positive emotionality.

PubMed

Kujawa, Autumn; Proudfit, Greg Hajcak; Kessel, Ellen M; Dyson, Margaret; Olino, Thomas; Klein, Daniel N

2015-01-01

Reward reactivity and positive emotion are key components of a theoretical, early-emerging approach motivational system, yet few studies have examined associations between positive emotion and neural reactivity to reward across development. In this multi-method prospective study, we examined the association of laboratory observations of positive emotionality (PE) at age 3 and self-reported positive affect (PA) at age 9 with an event-related potential component sensitive to the relative response to winning vs. losing money, the feedback negativity (ΔFN), at age 9 (N=381). Males had a larger ΔFN than females, and both greater observed PE at age 3 and self-reported PA at age 9 significantly, but modestly, predicted an enhanced ΔFN at age 9. Negative emotionality and behavioral inhibition did not predict ΔFN. Results contribute to understanding the neural correlates of PE and suggest that the FN and PE may be related to the same biobehavioral approach system. Copyright © 2014 Elsevier B.V. All rights reserved.

Reporting of conflicts of interest in oral presentations at medical conferences: a delegate-based prospective observational study

PubMed Central

Grey, Andrew; Avenell, Alison; Dalbeth, Nicola; Stewart, Fiona; Bolland, Mark J

2017-01-01

Objective To assess the prevalence, location, presentation and consistency of conflict of interest statements in oral presentations at medical conferences Design Prospective, delegate-based observational study Sample 201 oral presentations at 5 medical conferences in 2016 Main outcome measures Presence of a conflict of interest statement, its location within the presentation and its duration of display. Concordance between conflict of interest disclosures in oral presentations and written abstracts or meeting speaker information Results Conflict of interest statements were present in 143/201 (71%) presentations (range for conferences 26%–100%). 118 of the 141 evaluable statements (84%) were reported on a specific slide. Slides containing conflict of interest statements were displayed for a median (IQR) 2 s (1–5), range for conferences 1.25–7.5 s. Duration of display was shorter when the slide contained only the conflict of interest statement, 2 s (1–3.5), than when it contained other information, 8 s (3–17), but was not affected by type of presentation or whether a conflict of interest was disclosed. When a conflict of interest was disclosed, 27/84 (32%) presenters discussed an aspect of it. Discordance between the presence of a conflict of interest disclosure in the oral presentation and written formats occurred for 22% of presentations. Conclusion In oral presentations at the medical conferences we assessed, conflict of interest statements were often missing, displayed too briefly to be read and understood, or not discussed/explained by the presenter. They were sometimes discordant with statements in the corresponding written formats. Conference delegates’ ability to assess the objectivity and quality of the information in oral presentations may therefore have been diminished. PMID:28939580

Reporting of conflicts of interest in oral presentations at medical conferences: a delegate-based prospective observational study.

PubMed

Grey, Andrew; Avenell, Alison; Dalbeth, Nicola; Stewart, Fiona; Bolland, Mark J

2017-09-21

To assess the prevalence, location, presentation and consistency of conflict of interest statements in oral presentations at medical conferences DESIGN: Prospective, delegate-based observational study SAMPLE: 201 oral presentations at 5 medical conferences in 2016 MAIN OUTCOME MEASURES: Presence of a conflict of interest statement, its location within the presentation and its duration of display. Concordance between conflict of interest disclosures in oral presentations and written abstracts or meeting speaker information RESULTS: Conflict of interest statements were present in 143/201 (71%) presentations (range for conferences 26%-100%). 118 of the 141 evaluable statements (84%) were reported on a specific slide. Slides containing conflict of interest statements were displayed for a median (IQR) 2 s (1-5), range for conferences 1.25-7.5 s. Duration of display was shorter when the slide contained only the conflict of interest statement, 2 s (1-3.5), than when it contained other information, 8 s (3-17), but was not affected by type of presentation or whether a conflict of interest was disclosed. When a conflict of interest was disclosed, 27/84 (32%) presenters discussed an aspect of it. Discordance between the presence of a conflict of interest disclosure in the oral presentation and written formats occurred for 22% of presentations. In oral presentations at the medical conferences we assessed, conflict of interest statements were often missing, displayed too briefly to be read and understood, or not discussed/explained by the presenter. They were sometimes discordant with statements in the corresponding written formats. Conference delegates' ability to assess the objectivity and quality of the information in oral presentations may therefore have been diminished. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Meta-analyses including data from observational studies.

PubMed

O'Connor, Annette M; Sargeant, Jan M

2014-02-15

Observational studies represent a wide group of studies where the disease or condition of interest is naturally occurring and the investigator does not control allocation to interventions or exposures. Observational studies are used to test hypotheses about the efficacy of interventions or about exposure-disease relationships, to estimate incidence or prevalence of conditions, and to assess the sensitivity and specificity of diagnostic assays. Experimental-study designs and randomized controlled trials (RCTs) can also contribute to the body of evidence about such questions. Meta-analyses (either with or without systematic reviews) aim to combine information from primary research studies to better describe the entire body of work. The aim of meta-analyses may be to obtain a summary effect size, or to understand factors that affect effect sizes. In this paper, we discuss the role of observational studies in meta-analysis questions and some factors to consider when deciding whether a meta-analysis should include results from such studies. Our suggestion is that one should only include studies that are not at high risk of inherent bias when calculating a summary effect size. Study design however can be a meaningful variable in assessment of outcome heterogeneity. Copyright © 2013 Elsevier B.V. All rights reserved.

IVHS Institutional Issues and Case Studies, Analysis and Lessons Learned, Final Report

DOT National Transportation Integrated Search

1994-04-01

This 'Analysis and Lessons Learned' report contains observations, conclusions, and recommendations based on the performance of six case studies of Intelligent Vehicle-Highway Systems (IVHS) projects. Information to support the development of the case...

Design and implementation of observational studies to measure disease burden with a focus on stroke.

PubMed

Howard, George; Howard, Virginia J

2018-02-01

Observational epidemiological studies have the dual goals of measuring disease burden and assessing the association between exposures and outcomes. This report focuses on the first of these goals and provides an overview of design considerations of commonly used approaches, specifically community surveillance studies, cross-sectional studies, and longitudinal cohort studies. Each of these designs has strengths and weaknesses, with no study design being superior in all cases. Rather, these designs are complementary to achieve a better understanding of the burden of stroke.

Identifying Key Components for an Effective Case Report Poster: An Observational Study

PubMed Central

Paranjape, Anuradha; Estrada, Carlos

2008-01-01

BACKGROUND Residents demonstrate scholarly activity by presenting posters at academic meetings. Although recommendations from national organizations are available, evidence identifying which components are most important is not. OBJECTIVE To develop and test an evaluation tool to measure the quality of case report posters and identify the specific components most in need of improvement. DESIGN Faculty evaluators reviewed case report posters and provided on-site feedback to presenters at poster sessions of four annual academic general internal medicine meetings. A newly developed ten-item evaluation form measured poster quality for specific components of content, discussion, and format (5-point Likert scale, 1 = lowest, 5 = highest). Main outcome measure(s): Evaluation tool performance, including Cronbach alpha and inter-rater reliability, overall poster scores, differences across meetings and evaluators and specific components of the posters most in need of improvement. RESULTS Forty-five evaluators from 20 medical institutions reviewed 347 posters. Cronbach’s alpha of the evaluation form was 0.84 and inter-rater reliability, Spearman’s rho 0.49 ( < 0.001). The median score was 4.1 (Q1 -Q3, 3.7-4.6)(Q1 = 25th, Q3 = 75th percentile). The national meeting median score was higher than the regional meetings (4.4 vs, 4.0,  < 0.001). We found no difference in faculty scores. The following areas were identified as most needing improvement: clearly state learning objectives, tie conclusions to learning objectives, and use appropriate amount of words. CONCLUSIONS Our evaluation tool provides empirical data to guide trainees as they prepare posters for presentation which may improve poster quality and enhance their scholarly productivity. PMID:19089510

Quality of Reporting and Study Design of CKD Cohort Studies Assessing Mortality in the Elderly Before and After STROBE: A Systematic Review

PubMed Central

Brück, Katharina; Methven, Shona; Evans, Rebecca; Stel, Vianda S.; Jager, Kitty J.; Hooft, Lotty; Ben-Shlomo, Yoav; Caskey, Fergus

2016-01-01

Background The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was published in October 2007 to improve quality of reporting of observational studies. The aim of this review was to assess the impact of the STROBE statement on observational study reporting and study design quality in the nephrology literature. Study Design Systematic literature review. Setting & Population European and North American, Pre-dialysis Chronic Kidney Disease (CKD) cohort studies. Selection Criteria for Studies Studies assessing the association between CKD and mortality in the elderly (>65 years) published from 1st January 2002 to 31st December 2013 were included, following systematic searching of MEDLINE & EMBASE. Predictor Time period before and after the publication of the STROBE statement. Outcome Quality of study reporting using the STROBE statement and quality of study design using the Newcastle Ottawa Scale (NOS), Scottish Intercollegiate Guidelines Network (SIGN) and Critical Appraisal Skills Programme (CASP) tools. Results 37 papers (11 Pre & 26 Post STROBE) were identified from 3621 potential articles. Only four of the 22 STROBE items and their sub-criteria (objectives reporting, choice of quantitative groups and description of and carrying out sensitivity analysis) showed improvements, with the majority of items showing little change between the period before and after publication of the STROBE statement. Pre- and post-period analysis revealed a Manuscript STROBE score increase (median score 77.8% (Inter-quartile range [IQR], 64.7–82.0) vs 83% (IQR, 78.4–84.9, p = 0.05). There was no change in quality of study design with identical median scores in the two periods for NOS (Manuscript NOS score 88.9), SIGN (Manuscript SIGN score 83.3) and CASP (Manuscript CASP score 91.7) tools. Limitations Only 37 Studies from Europe and North America were included from one medical specialty. Assessment of study design largely reliant on good

Evaluation of the Endorsement of the STrengthening the REporting of Genetic Association Studies (STREGA) Statement on the Reporting Quality of Published Genetic Association Studies

PubMed Central

Nedovic, Darko; Panic, Nikola; Pastorino, Roberta; Ricciardi, Walter; Boccia, Stefania

2016-01-01

The STrengthening the REporting of Genetic Association studies (STREGA) statement was based on the STrengthening the REporting of OBservational studies in Epidemiology (STROBE) statement, and it was published in 2009 in order to improve the reporting of genetic association (GA) studies. Our aim was to evaluate the impact of STREGA endorsement on the quality of reporting of GA studies published in journals in the field of genetics and heredity (GH). Quality of reporting was evaluated by assessing the adherence of papers to the STREGA checklist. After identifying the GH journals that endorsed STREGA in their instructions for authors, we randomly appraised papers published in 2013 from journals endorsing STREGA that published GA studies (Group A); in GH journals that never endorsed STREGA (Group B); in GH journals endorsing STREGA, but in the year preceding its endorsement (Group C); and in the same time period as Group C from GH journals that never endorsed STREGA (Group D). The STREGA statement was referenced in 29 (18.1%) of 160 GH journals, of which 18 (62.1%) journals published GA studies. Among the 18 journals endorsing STREGA, we found a significant increase in the overall adherence to the STREGA checklist over time (A vs C; P < 0.0001). Adherence to the STREGA checklist was significantly higher in journals endorsing STREGA compared to those that did not endorse the statement (A vs B; P = 0.04). No significant improvement was detected in the adherence to STREGA items in journals not endorsing STREGA over time (B vs D; P > 0.05). The endorsement of STREGA resulted in an increase in quality of reporting of GA studies over time, while no similar improvement was reported for journals that never endorsed STREGA. PMID:27349199

The Broader Autism Phenotype in Mothers is Associated with Increased Discordance between Maternal-Reported and Clinician-Observed Instruments That Measure Child Autism Spectrum Disorder

ERIC Educational Resources Information Center

Rubenstein, Eric; Edmondson Pretzel, Rebecca; Windham, Gayle C.; Schieve, Laura A.; Wiggins, Lisa D.; DiGuiseppi, Carolyn; Olshan, Andrew F.; Howard, Annie G.; Pence, Brian W.; Young, Lisa; Daniels, Julie

2017-01-01

Autism spectrum disorder (ASD) diagnosis relies on parent-reported and clinician-observed instruments. Sometimes, results between these instruments disagree. The broader autism phenotype (BAP) in parent-reporters may be associated with discordance. Study to Explore Early Development data (N = 712) were used to address whether mothers with BAP and…

Quality of Reporting and Study Design of CKD Cohort Studies Assessing Mortality in the Elderly Before and After STROBE: A Systematic Review.

PubMed

Rao, Anirudh; Brück, Katharina; Methven, Shona; Evans, Rebecca; Stel, Vianda S; Jager, Kitty J; Hooft, Lotty; Ben-Shlomo, Yoav; Caskey, Fergus

2016-01-01

The STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement was published in October 2007 to improve quality of reporting of observational studies. The aim of this review was to assess the impact of the STROBE statement on observational study reporting and study design quality in the nephrology literature. Systematic literature review. European and North American, Pre-dialysis Chronic Kidney Disease (CKD) cohort studies. Studies assessing the association between CKD and mortality in the elderly (>65 years) published from 1st January 2002 to 31st December 2013 were included, following systematic searching of MEDLINE & EMBASE. Time period before and after the publication of the STROBE statement. Quality of study reporting using the STROBE statement and quality of study design using the Newcastle Ottawa Scale (NOS), Scottish Intercollegiate Guidelines Network (SIGN) and Critical Appraisal Skills Programme (CASP) tools. 37 papers (11 Pre & 26 Post STROBE) were identified from 3621 potential articles. Only four of the 22 STROBE items and their sub-criteria (objectives reporting, choice of quantitative groups and description of and carrying out sensitivity analysis) showed improvements, with the majority of items showing little change between the period before and after publication of the STROBE statement. Pre- and post-period analysis revealed a Manuscript STROBE score increase (median score 77.8% (Inter-quartile range [IQR], 64.7-82.0) vs 83% (IQR, 78.4-84.9, p = 0.05). There was no change in quality of study design with identical median scores in the two periods for NOS (Manuscript NOS score 88.9), SIGN (Manuscript SIGN score 83.3) and CASP (Manuscript CASP score 91.7) tools. Only 37 Studies from Europe and North America were included from one medical specialty. Assessment of study design largely reliant on good reporting. This study highlights continuing deficiencies in the reporting of STROBE items and their sub-criteria in cohort

Reporting of teratology studies.

PubMed

Barrow, Paul C; Reynaud, Lucie

2013-01-01

The regulatory toxicology report is an unusual document that requires a particular skill to write. The report must be clear, accurate, concise, and focused. A clear and direct writing style is required. The end-users of the report will hope to find the information they seek with as little effort as possible. Few, or none, will read the entire document. The author should aim to appease the user by obliging him to read as little text and turn as few pages as possible. This chapter gives tips and guidance on how to present the experimental data and write the narrative text in the final study report for a teratology study.

Quality of Parent-Adolescent Conversations About Sex and Adolescent Sexual Behavior: An Observational Study.

PubMed

Rogers, Adam A; Ha, Thao; Stormshak, Elizabeth A; Dishion, Thomas J

2015-08-01

Studies suggest that the quality of parent-adolescent communication about sex uniquely predicts adolescent sexual behavior. Previous studies have relied predominantly on self-report data. Observational methods, which are not susceptible to self-report biases, may be useful in examining the associations between the quality of parent-adolescent communication about sex and adolescent sexual behavior more objectively. With a sample of adolescents (N = 55, 58% male, 44% white, Mage = 15.8) and their parents, we used hierarchical logistic regression analyses to examine the associations between the observed quality of parent-adolescent communication about dating and sex and the likelihood of adolescents' sexual intercourse. The quality of parent-adolescent communication about dating and sex predicted sexual behavior. Specifically, lecturing was associated with a higher likelihood of adolescents having had sexual intercourse. The quality of parent-adolescent communication about sex is a unique correlate of adolescent sexual behavior and warrants further investigation. Thus, it serves as a potential target of preventive interventions that aim to foster adolescent sexual health behaviors. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Treating Pain in Pregnancy with Acupuncture: Observational Study Results from a Free Clinic in New Zealand.

PubMed

Soliday, Elizabeth; Betts, Debra

2018-02-01

Clinic-based acupuncturists, midwives, and physiotherapists have reported using acupuncture to treat lumbopelvic pain in pregnancy, a common condition that may affect functioning and quality of life. To contribute to the emerging evidence on treatment outcomes, we collected patient-reported pain reduction data from women treated during pregnancy in a no-pay, hospital-based acupuncture service in New Zealand. Observational study of patient-reported symptom reduction.The main outcome measure was the MYMOP (Measure Your Medical Outcome Profile), a brief, validated self-report instrument. Open-ended questions on treatment experiences and adverse events were included. Of the 81 women on whom we had complete treatment data, the majority (N = 72, 89%) reported clinically meaningful symptom reduction. Patient-reported adverse events were infrequent and mild. Patient-reported and treatment-related lumbopelvic pain symptom reduction findings provide further evidence that acupuncture in pregnancy is safe and beneficial in a field setting. We discuss this study's unique contributions in providing guidance for clinicians who practice acupuncture in pregnancy, including midwives, physiotherapists, and physicians. Copyright © 2018. Published by Elsevier B.V.

Observational studies of roAp stars

NASA Astrophysics Data System (ADS)

Sachkov, M.

2014-11-01

Rapidly oscillating Ap (roAp) stars are high-overtone, low-degree p-mode pulsators that are also chemically peculiar magnetic A stars. Until recently the classical asteroseismic analysis i.e. frequency analysis, of these stars was based on ground and space photometric observations. Significant progress was achieved through access to uninterrupted, ultra-high-precision data from MOST, COROT and Kepler satellites. Over the last ten years the study of roAp stars has been altered drastically from an observational point of view through studies of time-resolved, high-resolution spectra. Their unusual pulsational characteristics, caused by an interplay between the short vertical lengths of the pulsation waves and strong stratification of chemical elements, allow us to examine the upper roAp atmosphere in more detail than is possible for any star except the Sun. In this paper I review the results of recent studies of the pulsations of roAp stars.

Observation and Coding Manual for the Longitudinal Study of Reading Comprehension and Science Concept Acquisition (Third Edition). Technical Report No. L-1.

ERIC Educational Resources Information Center

Meyer, Linda A.; And Others

This manual describes the model--specifically the observation procedures and coding systems--used in a longitudinal study of how children learn to comprehend what they read, with particular emphasis on science texts. Included are procedures for the following: identifying students; observing--recording observations and diagraming the room; writing…

Standardized Efficacy Study Report and Efficacy Study Summary

EPA Pesticide Factsheets

The study report form contains all of the required elements of a study report as found in 40 CFR part 160, and meets the requirements of PR Notice 2011-3. We encourage registrants to use this non-mandatory report format to facilitate the review process.

Observational studies are complementary to randomized controlled trials.

PubMed

Grootendorst, Diana C; Jager, Kitty J; Zoccali, Carmine; Dekker, Friedo W

2010-01-01

Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alternative to doing nothing in order to obtain estimates of treatment effect. It should be noted that such studies should be performed with caution and correctly. The aims of this review are (1) to explain why RCTs are considered the optimal study design to evaluate treatment effects, (2) to describe the situations in which an RCT is not possible and observational studies are an adequate alternative, and (3) to explain when randomization is not needed and can be approximated in observational studies. Examples from the nephrology literature are used for illustration. Copyright 2009 S. Karger AG, Basel.

Caregiver talk to young Spanish-English bilinguals: Comparing direct observation and parent-report measures of dual-language exposure

PubMed Central

Marchman, Virginia A.; Martínez, Lucía Z.; Hurtado, Nereyda; Grüter, Theres; Fernald, Anne

2016-01-01

In research on language development by bilingual children, the early language environment is commonly characterized in terms of the relative amount of exposure a child gets to each language based on parent report. Little is known about how absolute measures of child-directed speech in two languages relate to language growth. In this study of 3-year-old Spanish-English bilinguals (n = 18), traditional parent-report estimates of exposure were compared to measures of the number of Spanish and English words children heard during naturalistic audio recordings. While the two estimates were moderately correlated, observed numbers of child-directed words were more consistently predictive of children's processing speed and standardized test performance, even when controlling for reported proportion of exposure. These findings highlight the importance of caregiver engagement in bilingual children's language outcomes in both of the languages they are learning. PMID:27197746

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2015-07-01

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

The Potential Utility of Urinary Biomarkers for Risk Prediction in Combat Casualties: A Prospective Observational Cohort Study

DTIC Science & Technology

2015-06-16

are associated with poor outcomes, including death and the need for renal replacement therapy. Methods : We conducted a prospective, observational study...penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE 16 JUN 2015...2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE The Potential Utility of Urinary Biomarkers for Risk Prediction in Combat

Observational study of sleep disturbances in advanced cancer.

PubMed

Davies, Andrew Neil; Patel, Shuchita D; Gregory, Amanda; Lee, Bernadette

2017-12-01

To determine the prevalence of nightmares, sleep terrors and vivid dreams in patients with advanced cancer (and the factors associated with them in this group of patients). The study was a multicentre, prospective observational study. Participants were patients with locally advanced/metastatic cancer, who were under the care of a specialist palliative care team. Data were collected on demographics, cancer diagnosis, cancer treatment, current medication, performance status, sleep quality (Pittsburgh Sleep Quality Index), dreams and nightmares, and physical and psychological symptoms (Memorial Symptom Assessment Scale-Short Form). 174 patients completed the study. Sleep quality was poor in 70.5% participants and was worse in younger patients and in inpatients (hospital, hospice). 18% of patients reported nightmares, 8% sleep terrors and 34% vivid dreams. Nightmares were associated with poor sleep quality and greater sleep disturbance; nightmares were also associated with greater physical and psychological burden. Nightmares (and vivid dreams) were not associated with the use of opioid analgesics. Nightmares do not seem to be especially common in patients with advanced cancer, and when they do occur, there is often an association with sleep disturbance, and/or physical and psychological burden. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Institute Study Report

NASA Technical Reports Server (NTRS)

Whitaker, Ann; Steadman, Jackie; Little, Sally; Underwood, Debra; Blackman, Mack; Simonds, Judy

1997-01-01

This report documents a study conducted by the MSFC working group on Institutes in 1995 on the structure, organization and business arrangements of Institutes at a time when the agency was considering establishing science institutes. Thirteen institutes, ten science centers associated with the state of Georgia, Stanford Research Institute (SRI), and IIT Research Institute (IITRI), and general data on failed institutes were utilized to form this report. The report covers the working group's findings on institute mission, structure, director, board of directors/advisors, the working environment, research arrangements, intellectual property rights, business management, institute funding, and metrics.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

The LAAS network observation for studying time correlations in extensive air showers

NASA Astrophysics Data System (ADS)

Ochi, Nobuaki; Iyono, A.; Kimura, Hitoomi; Konishi, Takeharu; Nakamura, Toru; Nakatsuka, Takao; Ohara, Soji; Ohmori, Nobuharu; Saito, Katsuhiko; Takahashi, Nobusuke; Tsuji, Shuhei; Wada, Tomonori; Yamamoto, Isao; Yamashita, Yoshihiko; Yanagimoto, Yukio

2003-02-01

The Large Area Air Shower (LAAS) group has been performing a network observation of extensive air showers (EAS) since 1996 in Japan. Ten compact EAS arrays are operating simultaneously at distant stations (up to ≍1000 km) and detecting EAS with mean energy of ≍1015 eV. Each station has 4--12 scintillation counters and a Global Positioning System (GPS), which provides time stamps of EAS triggers with an accuracy of 1μs. As a consequence of the comparable time stamps, uniformly-adjusted detectors and a standardized data format among all stations, we can treat the independent observations as a gigantic EAS detector system as a whole. The primary purpose of the network observation is to study large-scale correlations in ultra-high-energy cosmic rays. On the other hand, three nearby stations within 1~km distance at Okayama area have a possibility to detect extremely-high-energy EAS (≍1019 eV) as coincident triggers of the three stations. The present status of the network and some results from computer simulations are reported here.

Manifestations of personality in Online Social Networks: self-reported Facebook-related behaviors and observable profile information.

PubMed

Gosling, Samuel D; Augustine, Adam A; Vazire, Simine; Holtzman, Nicholas; Gaddis, Sam

2011-09-01

Despite the enormous popularity of Online Social Networking sites (OSNs; e.g., Facebook and Myspace), little research in psychology has been done on them. Two studies examining how personality is reflected in OSNs revealed several connections between the Big Five personality traits and self-reported Facebook-related behaviors and observable profile information. For example, extraversion predicted not only frequency of Facebook usage (Study 1), but also engagement in the site, with extraverts (vs. introverts) showing traces of higher levels of Facebook activity (Study 2). As in offline contexts, extraverts seek out virtual social engagement, which leaves behind a behavioral residue in the form of friends lists and picture postings. Results suggest that, rather than escaping from or compensating for their offline personality, OSN users appear to extend their offline personalities into the domains of OSNs.

Observed Workplace Incivility toward Women, Perceptions of Interpersonal Injustice, and Observer Occupational Well-Being: Differential Effects for Gender of the Observer

PubMed Central

Miner, Kathi N.; Cortina, Lilia M.

2016-01-01

The present study examined perceptions of interpersonal injustice as a mediator of the relationship between observed incivility toward women at work and employees' occupational well-being. We also examined gender of the observer as a moderator of these mediational relationships. Using online survey data from 1702 (51% women; 92% White) employees, results showed that perceptions of injustice partially mediated the relationship between observed incivility toward women and job satisfaction, turnover intentions, and organizational trust. Men reported greater perceptions of injustice than did women the more they observed the uncivil treatment of women at work, and the indirect effects of observed incivility toward women on well-being were stronger for men compared to women. Observed incivility toward women also had direct relationships with the occupational well-being outcomes over and above the impact mediated through injustice, particularly for women. Specifically, observing incivility toward female coworkers directly related to lowered job satisfaction and perceptions of safety for female bystanders. In addition, although both male and female bystanders reported heightened turnover intentions and lowered trust in the organization with higher levels of observed incivility toward women, these relationships were stronger for female than male observers. Our findings both replicate and extend past research on vicarious workplace incivility toward women. PMID:27242558

Observed Workplace Incivility toward Women, Perceptions of Interpersonal Injustice, and Observer Occupational Well-Being: Differential Effects for Gender of the Observer.

PubMed

Miner, Kathi N; Cortina, Lilia M

2016-01-01

The present study examined perceptions of interpersonal injustice as a mediator of the relationship between observed incivility toward women at work and employees' occupational well-being. We also examined gender of the observer as a moderator of these mediational relationships. Using online survey data from 1702 (51% women; 92% White) employees, results showed that perceptions of injustice partially mediated the relationship between observed incivility toward women and job satisfaction, turnover intentions, and organizational trust. Men reported greater perceptions of injustice than did women the more they observed the uncivil treatment of women at work, and the indirect effects of observed incivility toward women on well-being were stronger for men compared to women. Observed incivility toward women also had direct relationships with the occupational well-being outcomes over and above the impact mediated through injustice, particularly for women. Specifically, observing incivility toward female coworkers directly related to lowered job satisfaction and perceptions of safety for female bystanders. In addition, although both male and female bystanders reported heightened turnover intentions and lowered trust in the organization with higher levels of observed incivility toward women, these relationships were stronger for female than male observers. Our findings both replicate and extend past research on vicarious workplace incivility toward women.

Foundation observation of teaching project--a developmental model of peer observation of teaching.

PubMed

Pattison, Andrew Timothy; Sherwood, Morgan; Lumsden, Colin James; Gale, Alison; Markides, Maria

2012-01-01

Peer observation of teaching is important in the development of educators. The foundation curriculum specifies teaching competencies that must be attained. We created a developmental model of peer observation of teaching to help our foundation doctors achieve these competencies and develop as educators. A process for peer observation was created based on key features of faculty development. The project consisted of a pre-observation meeting, the observation, a post-observation debrief, writing of reflective reports and group feedback sessions. The project was evaluated by completion of questionnaires and focus groups held with both foundation doctors and the students they taught to achieve triangulation. Twenty-one foundation doctors took part. All completed reflective reports on their teaching. Participants described the process as useful in their development as educators, citing specific examples of changes to their teaching practice. Medical students rated the sessions as better or much better quality as their usual teaching. The study highlights the benefits of the project to individual foundation doctors, undergraduate medical students and faculty. It acknowledges potential anxieties involved in having teaching observed. A structured programme of observation of teaching can deliver specific teaching competencies required by foundation doctors and provides additional benefits.

Arctic Observing Experiment (AOX) Field Campaign Report

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

Rigor, Ignatius; Johnson, Jim; Motz, Emily

Our ability to understand and predict weather and climate requires an accurate observing network. One of the pillars of this network is the observation of the fundamental meteorological parameters: temperature, air pressure, and wind. We plan to assess our ability to measure these parameters for the polar regions during the Arctic Observing Experiment (AOX, Figure 1) to support the International Arctic Buoy Programme (IABP), Arctic Observing Network (AON), International Program for Antarctic Buoys (IPAB), and Southern Ocean Observing System (SOOS). Accurate temperature measurements are also necessary to validate and improve satellite measurements of surface temperature across the Arctic. Support formore » research associated with the campaign is provided by the National Science Foundation, and by other US agencies contributing to the US Interagency Arctic Buoy Program. In addition to the support provided by the U.S Department of Energy (DOE) Atmospheric Radiation Measurement (ARM) Climate Research Facility’s North Slope of Alaska (NSA) site at Barrow and the National Science Foundation (NSF), the U.S. IABP is supported by the U.S. Coast Guard (USCG), the National Aeronautics and Space Administration (NASA), the National Ice Center (NIC), the National Oceanic and Atmospheric Administration (NOAA), and the Office of Naval Research (ONR).« less

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Observational Studies.

PubMed

Snyder, Graham M; Young, Heather; Varman, Meera; Milstone, Aaron M; Harris, Anthony D; Munoz-Price, Silvia

2016-10-01

Observational studies compare outcomes among subjects with and without an exposure of interest, without intervention from study investigators. Observational studies can be designed as a prospective or retrospective cohort study or as a case-control study. In healthcare epidemiology, these observational studies often take advantage of existing healthcare databases, making them more cost-effective than clinical trials and allowing analyses of rare outcomes. This paper addresses the importance of selecting a well-defined study population, highlights key considerations for study design, and offers potential solutions including biostatistical tools that are applicable to observational study designs. Infect Control Hosp Epidemiol 2016;1-6.

Airglow studies using observations made with the GLO instrument on the Space Shuttle

NASA Astrophysics Data System (ADS)

Alfaro Suzan, Ana Luisa

2009-12-01

Our understanding of Earth's upper atmosphere has advanced tremendously over the last few decades due to our enhanced capacity for making remote observations from space. Space based observations of Earth's daytime and nighttime airglow emissions are very good examples of such enhancements to our knowledge. The terrestrial nighttime airglow, or nightglow, is barely discernible to the naked eye as viewed from Earth's surface. However, it is clearly visible from space - as most astronauts have been amazed to report. The nightglow consists of emissions of ultraviolet, visible and near-infrared radiation from electronically excited oxygen molecules and atoms and vibrationally excited OH molecules. It mostly emanates from a 10 km thick layer located about 100 km above Earth's surface. Various photochemical models have been proposed to explain the production of the emitting species. In this study some unique observations of Earth's nightglow made with the GLO instrument on NASA's Space Shuttle, are analyzed to assess the proposed excitation models. Previous analyses of these observations by Broadfoot and Gardner (2001), performed using a 1-D inversion technique, have indicated significant spatial structures and have raised serious questions about the proposed nightglow excitation models. However, the observation of such strong spatial structures calls into serious question the appropriateness of the adopted 1-D inversion technique and, therefore, the validity of the conclusions. In this study a more rigorous 2-D tomographic inversion technique is developed and applied to the available GLO data to determine if some of the apparent discrepancies can be explained by the limitations of the previously applied 1-D inversion approach. The results of this study still reveal some potentially serious inadequacies in the proposed photochemical models. However, alternative explanations for the discrepancies between the GLO observations and the model expectations are suggested. These

Evolution of Observation: Implementing Programmatic Change

ERIC Educational Resources Information Center

Bender-Slack, Delane A.; Young, Teresa

2013-01-01

In the study reported, we examine the evolution of preservice teacher observation, focusing on the essential nature of observation to preservice teachers' learning about teaching while in the field. The study was 3 years long, and it involved 79 preservice teachers during semester-long language arts methods courses in early childhood and…

What is newsworthy? Longitudinal study of the reporting of medical research in two British newspapers

PubMed Central

Bartlett, Christopher; Sterne, Jonathan; Egger, Matthias

2002-01-01

Objective To assess the characteristics of medical research that is press released by general medical journals and reported in newspapers. Design Longitudinal study. Data sources All original research articles published in Lancet and BMJ during 1999 and 2000. Main outcome measures Inclusion of articles in Lancet or BMJ press releases, and reporting of articles in Times or Sun newspapers. Results Of 1193 original research articles, 517 (43%) were highlighted in a press release and 81 (7%) were reported in one or both newspapers. All articles covered in newspapers had been press released. The probability of inclusion in press releases was similar for observational studies and randomised controlled trials, but trials were less likely to be covered in the newspapers (odds ratio 0.15 (95% confidence interval 0.06 to 0.37)). Good news and bad news were equally likely to be press released, but bad news was more likely to be reported in newspapers (1.74 (1.07 to 2.83)). Studies of women's health, reproduction, and cancer were more likely to be press released and covered in newspapers. Studies from industrialised countries other than Britain were less likely to be reported in newspapers (0.51 (0.31 to 0.82)), and no studies from developing countries were covered. Conclusions Characteristics of articles were more strongly associated with selection for reporting in newspapers than with selection for inclusion in press releases, although each stage influenced the reporting process. Newspapers underreported randomised trials, emphasised bad news from observational studies, and ignored research from developing countries. What is already known on this topicNewspapers are an important source of information about the results of medical researchThere are two stages on the path to newspaper coverage—selection by medical journal editors of articles to be press released and the selection of newsworthy articles by journalistsWhat this study addsExamination of press releasing by the

The BraveNet prospective observational study on integrative medicine treatment approaches for pain.

PubMed

Abrams, Donald I; Dolor, Rowena; Roberts, Rhonda; Pechura, Constance; Dusek, Jeffery; Amoils, Sandi; Amoils, Steven; Barrows, Kevin; Edman, Joel S; Frye, Joyce; Guarneri, Erminia; Kligler, Ben; Monti, Daniel; Spar, Myles; Wolever, Ruth Q

2013-06-24

Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. ClinicalTrials.gov, NCT01186341.

Observational evidence and strength of evidence domains: case examples

PubMed Central

2014-01-01

Background Systematic reviews of healthcare interventions most often focus on randomized controlled trials (RCTs). However, certain circumstances warrant consideration of observational evidence, and such studies are increasingly being included as evidence in systematic reviews. Methods To illustrate the use of observational evidence, we present case examples of systematic reviews in which observational evidence was considered as well as case examples of individual observational studies, and how they demonstrate various strength of evidence domains in accordance with current Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center (EPC) methods guidance. Results In the presented examples, observational evidence is used when RCTs are infeasible or raise ethical concerns, lack generalizability, or provide insufficient data. Individual study case examples highlight how observational evidence may fulfill required strength of evidence domains, such as study limitations (reduced risk of selection, detection, performance, and attrition); directness; consistency; precision; and reporting bias (publication, selective outcome reporting, and selective analysis reporting), as well as additional domains of dose-response association, plausible confounding that would decrease the observed effect, and strength of association (magnitude of effect). Conclusions The cases highlighted in this paper demonstrate how observational studies may provide moderate to (rarely) high strength evidence in systematic reviews. PMID:24758494

Depression and oxidative stress: results from a meta-analysis of observational studies.

PubMed

Palta, Priya; Samuel, Laura J; Miller, Edgar R; Szanton, Sarah L

2014-01-01

To perform a systematic review and meta-analysis that quantitatively tests and summarizes the hypothesis that depression results in elevated oxidative stress and lower antioxidant levels. We performed a meta-analysis of studies that reported an association between depression and oxidative stress and/or antioxidant status markers. PubMed and EMBASE databases were searched for articles published from January 1980 through December 2012. A random-effects model, weighted by inverse variance, was performed to pool standard deviation (Cohen's d) effect size estimates across studies for oxidative stress and antioxidant status measures, separately. Twenty-three studies with 4980 participants were included in the meta-analysis. Depression was most commonly measured using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria. A Cohen's d effect size of 0.55 (95% confidence interval = 0.47-0.63) was found for the association between depression and oxidative stress, indicating a roughly 0.55 of 1-standard-deviation increase in oxidative stress among individuals with depression compared with those without depression. The results of the studies displayed significant heterogeneity (I(2) = 80.0%, p < .001). A statistically significant effect was also observed for the association between depression and antioxidant status markers (Cohen's d = -0.24, 95% confidence interval = -0.33 to -0.15). This meta-analysis observed an association between depression and oxidative stress and antioxidant status across many different studies. Differences in measures of depression and markers of oxidative stress and antioxidant status markers could account for the observed heterogeneity. These findings suggest that well-established associations between depression and poor heath outcomes may be mediated by high oxidative stress.

Interpreting Camp to Parents: A Better Way to Observe--Record--Report. An Occasional Paper.

ERIC Educational Resources Information Center

Shopper, Moisy

1980-01-01

Camps offer a unique opportunity to inform parents of the psychological workings of their child through information based on a large repertoire of situations. Camps can be interpreted to parents as a better way to observe, record, and report how their children: (1) reacted to "on-hand contact"; (2) accepted duties and responsibility; (3)…

Earth observing system. Data and information system. Volume 2A: Report of the EOS Data Panel

NASA Technical Reports Server (NTRS)

1986-01-01

The purpose of this report is to provide NASA with a rationale and recommendations for planning, implementing, and operating an Earth Observing System data and information system that can evolve to meet the Earth Observing System's needs in the 1990s. The Earth Observing System (Eos), defined by the Eos Science and Mission Requirements Working Group, consists of a suite of instruments in low Earth orbit acquiring measurements of the Earth's atmosphere, surface, and interior; an information system to support scientific research; and a vigorous program of scientific research, stressing study of global-scale processes that shape and influence the Earth as a system. The Eos data and information system is conceived as a complete research information system that would transcend the traditional mission data system, and include additional capabilties such as maintaining long-term, time-series data bases and providing access by Eos researchers to relevant non-Eos data. The Working Group recommends that the Eos data and information system be initiated now, with existing data, and that the system evolve into one that can meet the intensive research and data needs that will exist when Eos spacecraft are returning data in the 1990s.

A Prospective Observation Study of Medical Toxicology Consultation in a U.S. Combat Theater.

PubMed

Maddry, Joseph K; Ng, Patrick C; Sessions, Daniel; Bebarta, Vikhyat S

2016-11-01

Since 2001, U.S. military personnel and active duty, uniformed physicians providing medical support have been deployed to Afghanistan. Medical toxicologists are among the physicians deployed. There is a paucity of information present in the literature that has documented cases treated by toxicologists in theater. This prospective observational study describes 15 male patients treated in theater by a military medical toxicologist. We performed a prospective observational study in which a medical toxicologist consulted and reported on deployed toxicology cases occurring during a 5-month deployment to Bagram, Afghanistan. Fifteen toxicology cases were collected during the 5-month period. The patients included three Afghan civilians, three U.S. civilians, and nine U.S. military personnel. Eight cases were attempts at recreational euphoria, two were self-harm attempts, two were from performance-enhancing supplements, two were accidental occupational exposures and one was alcohol withdrawal. Methanol was the most common exposure followed by dextromethorphan, supplements, opiates, and chlorine gas. In our study, we found that toxic alcohols and nonprescription medications were the most common exposures. In addition, this is the first study to describe bedside toxicology consults for U.S. combat forces in theater and the use of an observation unit for critically ill patients. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

A Pilot Study Comparing Observational and Questionnaire Surrogate Measures of Pesticide Exposure Among Residents Impacted by the Ecuadorian Flower Industry.

PubMed

Handal, Alexis J; McGough-Maduena, Alison; Páez, Maritza; Skipper, Betty; Rowland, Andrew S; Fenske, Richard A; Harlow, Siobán D

2015-01-01

Self-reported measures of residential pesticide exposure are commonly used in epidemiological studies, especially when financial and logistical resources are limited. However, self-reporting is prone to misclassification bias. This pilot study assesses the agreement between self-report of residential pesticide exposure with direct observation measures, in an agricultural region of Ecuador, as a cross-validation method in 26 participants (16 rose workers and 10 controls), with percent agreement and kappa statistics calculated. Proximity of homes to nearby flower farms was found to have only fair agreement (kappa =.35). The use of discarded plastics (kappa =.06) and wood (kappa =.13) were found to have little agreement. Results indicate that direct observation or measurement may provide more accurate appraisals of residential exposures, such as proximity to industrial farmland and the use of discarded materials obtained from the flower farms.

Evaluation of Multiclass Model Observers in PET LROC Studies

NASA Astrophysics Data System (ADS)

Gifford, H. C.; Kinahan, P. E.; Lartizien, C.; King, M. A.

2007-02-01

A localization ROC (LROC) study was conducted to evaluate nonprewhitening matched-filter (NPW) and channelized NPW (CNPW) versions of a multiclass model observer as predictors of human tumor-detection performance with PET images. Target localization is explicitly performed by these model observers. Tumors were placed in the liver, lungs, and background soft tissue of a mathematical phantom, and the data simulation modeled a full-3D acquisition mode. Reconstructions were performed with the FORE+AWOSEM algorithm. The LROC study measured observer performance with 2D images consisting of either coronal, sagittal, or transverse views of the same set of cases. Versions of the CNPW observer based on two previously published difference-of-Gaussian channel models demonstrated good quantitative agreement with human observers. One interpretation of these results treats the CNPW observer as a channelized Hotelling observer with implicit internal noise

Manifestations of Personality in Online Social Networks: Self-Reported Facebook-Related Behaviors and Observable Profile Information

PubMed Central

Augustine, Adam A; Vazire, Simine; Holtzman, Nicholas; Gaddis, Sam

2011-01-01

Abstract Despite the enormous popularity of Online Social Networking sites (OSNs; e.g., Facebook and Myspace), little research in psychology has been done on them. Two studies examining how personality is reflected in OSNs revealed several connections between the Big Five personality traits and self-reported Facebook-related behaviors and observable profile information. For example, extraversion predicted not only frequency of Facebook usage (Study 1), but also engagement in the site, with extraverts (vs. introverts) showing traces of higher levels of Facebook activity (Study 2). As in offline contexts, extraverts seek out virtual social engagement, which leaves behind a behavioral residue in the form of friends lists and picture postings. Results suggest that, rather than escaping from or compensating for their offline personality, OSN users appear to extend their offline personalities into the domains of OSNs. PMID:21254929

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

PubMed

Chua, S S; Tea, M H; Rahman, M H A

2009-04-01

Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

Terminal illness and the increased mortality risk of conventional antipsychotics in observational studies: a systematic review.

PubMed

Luijendijk, Hendrika J; de Bruin, Niels C; Hulshof, Tessa A; Koolman, Xander

2016-02-01

Numerous large observational studies have shown an increased risk of mortality in elderly users of conventional antipsychotics. Health authorities have warned against use of these drugs. However, terminal illness is a potentially strong confounder of the observational findings. So, the objective of this study was to systematically assess whether terminal illness may have biased the observational association between conventional antipsychotics and risk of mortality in elderly patients. Studies were searched in PubMed, CINAHL, Embase, the references of selected studies and articles referring to selected studies (Web of Science). Inclusion criteria were (i) observational studies that estimated (ii) the risk of all-cause mortality in (iii) new elderly users of (iv) conventional antipsychotics compared with atypical antipsychotics or no use. Two investigators assessed the characteristics of the exposure and reference groups, main results, measured confounders and methods used to adjust for unmeasured confounders. We identified 21 studies. All studies were based on administrative medical and pharmaceutical databases. Sicker and older patients received conventional antipsychotics more often than new antipsychotics. The risk of dying was especially high in the first month of use, and when haloperidol was administered per injection or in high doses. Terminal illness was not measured in any study. Instrumental variables that were used were also confounded by terminal illness. We conclude that terminal illness has not been adjusted for in observational studies that reported an increased risk of mortality risk in elderly users of conventional antipsychotics. As the validity of the evidence is questionable, so is the warning based on it. Copyright © 2015 John Wiley & Sons, Ltd.

Mothers' reports of play dates and observation of school playground behavior of children having high-functioning autism spectrum disorders.

PubMed

Frankel, Frederick D; Gorospe, Clarissa M; Chang, Ya-Chih; Sugar, Catherine A

2011-05-01

Children with high-functioning autism spectrum disorders (ASD) are generally included with typically developing peers at school. They have difficulties interacting with peers on the school playground. Previous literature suggests that having play dates in the home may be related to better peer acceptance at school. This study examines the relationship between mother-reported play date frequency and amount of conflict, and peer interaction observed on the school playground for a sample of 27 boys and 4 girls meeting structured interview and observation criteria for ASD. Measures of intellectual functioning, adaptive behavior, and social skills were included in a stepwise regression analysis to account for their impact on relationships between maternal play date reports, general peer acceptance at school (as rated by the child's teacher) and observations of school playground behavior. Results revealed that children with autism spectrum disorders who had more play dates in their home tended to spend a greater amount of time engaged in behaviors such as mutual offering of objects, conversing and other turn-taking activities with peers on the school playground. They also received more positive responses to their overtures from peers. These relationships remained highly significant even after accounting for other demographic, general social, and cognitive variables. The present results suggest that play date frequency is strongly related to school playground behavior. Owing to the design of this study, future research must assess whether play dates in the home promote better peer relationships on the playground or the reverse. In either case, the assessment of play dates, as well as observation of spontaneous unsupervised social interactions, are important outcome measures to consider in social skills interventions for children with high-functioning ASD. © 2010 The Authors. Journal of Child Psychology and Psychiatry © 2010 Association for Child and Adolescent Mental

Mothers’ Reports of Play Dates and Observation of School Playground Behavior of Children Having High-Functioning Autism Spectrum Disorders

PubMed Central

Frankel, Frederick D.; Gorospe, Clarissa M.; Chang, Ya-Chih; Sugar, Catherine A.

2010-01-01

Background Children with high functioning autism spectrum disorders (ASD) are generally included with typically developing peers at school. They have difficulties interacting with peers on the school play ground. Previous literature suggests that having play dates in the home may be related to better peer acceptance at school. Methods This study examines the relationship between mother-reported play date frequency and amount of conflict, and peer interaction observed on the school playground for a sample of 27 boys and 4 girls meeting structured interview and observation criteria for ASD. Measures of intellectual functioning, adaptive behavior, and social skills were included in a stepwise regression analysis to account for their impact on relationships between maternal play date reports, general peer acceptance at school (as rated by the child’s teacher) and observations of school playground behavior. Results Results revealed that children with autism spectrum disorders who had more play dates in their home tended to spend a greater amount of time engaged in behaviors such as mutual offering of objects, conversing and other turn taking activities with peers on the school playground. They also received more positive responses to their overtures from peers. These relationships remained highly significant even after accounting for other demographic, general social, and cognitive variables. Conclusions The present results suggest that play date frequency is strongly related to school playground behavior. Due to the design of this study, future research must assess whether play dates in the home promote better peer relationships on the playground or the reverse. In either case, the assessment of play dates, as well as observation of spontaneous unsupervised social interactions are important outcome measures to consider in social skills interventions for children with high functioning ASD. PMID:20860756

Report on Physics of Channelization: Theory, Experiment, and Observation

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

Kudrolli, Arshad

2014-05-19

The project involved a study of physical processes that create eroded channel and drainage networks. A particular focus was on how the shape of the channels and the network depended on the nature of the fluid flow. Our approach was to combine theoretical, experimental, and observational studies in close collaboration with Professor Daniel Rothman of the Massachusetts Institute of Technology. Laboratory -scaled experiments were developed and quantitative data on the shape of the pattern and erosion dynamics are obtained with a laser-aided topography technique and fluorescent optical imaging techniques.

Utilisation and Safety of Deferasirox: Results from an Observational Cohort Study in England.

PubMed

Osborne, Vicki; Davies, Miranda; Layton, Deborah; Shakir, Saad A W

2018-03-01

Deferasirox (EXJADE ® , Novartis, UK) is an oral iron-chelating agent primarily used to reduce chronic iron overload in patients receiving blood transfusions for various chronic anaemias and some non-transfusion dependant anaemias. The aim of this study was to examine the utilisation and safety of deferasirox used in general practice in England. A single exposure observational cohort study design was used. Patients were identified from dispensed prescriptions for deferasirox between September 2006 and September 2014. Outcome data were collected via postal questionnaires sent to prescribers ≥ 6 months after first dispensed prescription for an individual patient. Summary descriptive statistics were calculated. The evaluable cohort consisted of 122 patients, of which 41.8% were aged 2-17 years. Frequent reasons for prescribing were sickle cell anaemia (27/103 where specified, 26.2%) and beta thalassaemia (26, 25.2%). The majority of patients (43/51, 84.3%) were prescribed the licensed doses of 10 or 20 mg/kg/day at start. Prior measurements of serum creatinine were only reported for a small proportion this study (18/122, 14.8%). In total, 91 incident events were reported, including two of raised serum creatinine. These results show that deferasirox is largely being prescribed for its licensed indications in general practice in England and events reported were consistent with the known safety profile.

Position of peripheral venous cannulae and the incidence of thrombophlebitis: an observational study.

PubMed

Cicolini, Giancarlo; Bonghi, Antonia Pollidoro; Di Labio, Luisa; Di Mascio, Rocco

2009-06-01

This paper is a report of a study conducted to investigate the most suitable location of peripheral venous cannulae to reduce the incidence of thrombophlebitis. Peripheral intravenous cannulae are used for vascular access, but the site of insertion and size of the cannula could expose patients to local and systemic infectious complications. Small cannula size is an important factor in reducing the incidence of thrombophlebitis, but cannula location has not yet been studied. Evidence-based knowledge on how to prevent these complications is needed. An observational survey carried out was carried out in 2007 with 427 patients in one Italian hospital. A structured observation protocol was used to survey the frequency of thrombophlebitis and the relationship of location and size of peripheral intravenous cannulae. The variables evaluated were age, gender, cannula size and site of cannula location. Chi-square or Student t tests were used, and the adjusted odds ratios and relative 95% confidence intervals are reported. The frequency of peripheral intravenous cannulae thrombophlebitis was higher in females (OR:1.91;CI:1.20-3.03;P < 0.006). The highest incidence was found in patients with cannulae inserted in the dorsal side of the hand veins compared to those with cannulae inserted in cubital fossa veins (OR:3.33;CI:1.37-8.07; P < 0.001). The use of cubital fossa veins rather than forearm and hand veins should be encouraged to reduce the risk of thrombophlebitis in patients with peripheral intravenous cannulae.

An Observational Study of Instructional and Curricular Practices Used with Gifted and Talented Students in Regular Classrooms. Research Monograph 93104.

ERIC Educational Resources Information Center

Westberg, Karen L.; And Others

This report describes one part of the Classroom Practices Study, focusing on systematic observations of gifted and talented students in 46 third and fourth grade classrooms. The observations were designed to determine if and how teachers meet the needs of gifted and talented students in regular classroom settings. The Classroom Practices Record…

Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis

PubMed Central

2014-01-01

Background Efficacy of statins has been extensively studied, with much less information reported on their unintended effects. Evidence from randomized controlled trials (RCTs) on unintended effects is often insufficient to support hypotheses generated from observational studies. We aimed to systematically assess unintended effects of statins from observational studies in general populations with comparison of the findings where possible with those derived from randomized trials. Methods Medline (1998 to January 2012, week 3) and Embase (1998 to 2012, week 6) were searched using the standard BMJ Cohort studies filter. The search was supplemented with reference lists of all identified studies and contact with experts in the field. We included prospective studies with a sample size larger than 1,000 participants, case control (of any size) and routine health service linkage studies of over at least one year duration. Studies in subgroups of patients or follow-up of patient case series were excluded, as well as hospital-based cohort studies. Results Ninety studies were identified, reporting on 48 different unintended effects. Statins were associated with lower risks of dementia and cognitive impairment, venous thrombo-embolism, fractures and pneumonia, but these findings were attenuated in analyses restricted to higher quality studies (respectively: OR 0.74 (95% CI 0.62 to 0.87); OR 0.92 (95% CI 0.81 to 1.03); OR 0.97 (95% CI 0.88 to 1.05); OR 0.92 (95% CI 0.83 to 1.02)); and marked heterogeneity of effects across studies remained. Statin use was not related to any increased risk of depression, common eye diseases, renal disorders or arthritis. There was evidence of an increased risk of myopathy, raised liver enzymes and diabetes (respectively: OR 2.63 (95% CI 1.50 to 4.61); OR 1.54 (95% CI 1.47 to 1.62); OR 1.31 (95% CI 0.99 to 1.73)). Conclusions Our systematic review and meta-analyses indicate that high quality observational data can provide relevant evidence on

Time since death and decomposition of the human body: variables and observations in case and experimental field studies.

PubMed

Mann, R W; Bass, W M; Meadows, L

1990-01-01

Much of the difficulty in determining the time since death stems from the lack of systematic observation and research on the decomposition rate of the human body. Continuing studies conducted at the University of Tennessee, Knoxville, provide useful information on the impact of carrion insect activity, ambient temperature, rainfall, clothing, burial and depth, carnivores, bodily trauma, body weight, and the surface with which the body is in contact. This paper reports findings and observations accumulated during eight years of research and case studies that may clarify some of the questions concerning bodily decay.

Problem behaviors of low-income children with language delays: an observation study.

PubMed

Qi, Cathy Huaqing; Kaiser, Ann P

2004-06-01

Children from low-income families are at increased risk for significant behavioral and language problems. Early identification of these problems is essential for effective intervention. The purpose of the present study was to use multiple behavioral assessments to examine the behavioral profiles of sixty 3- and 4-year-old children from low-income families enrolled in Head Start programs and to compare the behavior characteristics of 32 children with language delays with those of 28 children with typical language development. Teachers completed the Child Behavior Checklist/Caregiver-Teacher Report Form/2-5 (CTRF; T. M. Achenbach, 1997) and the Social Skills Rating System (SSRS; F. M. Gresham and S. N. Elliott, 1990), and children were observed in the classrooms during structured and unstructured activities. Children with language delays exhibited more problem behaviors and poorer social skills on some of the observational measures than did children with typical language development, as predicted, but not on all.

Under-reporting of conflicts of interest among trialists: a cross-sectional study

PubMed Central

Schroll, Jeppe; Gøtzsche, Peter C; Lundh, Andreas

2015-01-01

Objectives To determine the prevalence of conflicts of interest (COIs) among Danish physicians who are authors of clinical drug trial reports and determine the extent of undisclosed COIs in trial publications. Design Cross-sectional study. Setting The 100 most recent drug trial reports with at least one Danish non-industry employed physician author published in a journal adhering to the International Committee of Medical Journal Editors' (ICMJE) manuscript guidelines. For each article, two observers independently extracted trial characteristics and the authors' COIs. Disclosed COIs were compared to what was registered on the Danish Health and Medicines Authority's public disclosure list. Participants Trial authors who are Danish physicians. Main outcome measures Number of disclosed and undisclosed COIs. Results One observer screened 928 articles and two observers assessed 120 articles for eligibility. The 100 included trials were published from February 2011 to May 2013 and included 318 Danish non-industry employed authors. Eighty-six of the 318 authors (27%) reported one or more COIs in the journal article. We found undisclosed COIs for 40 of 318 authors (13%) related to the trial sponsor or manufacturer of trial drugs. Seventy-nine of 318 authors (25%) had undisclosed COIs related to competing companies manufacturing drugs for the same indication and 136 (43%) had undisclosed COIs with any drug manufacturer. Conclusions Almost half of all authors had undisclosed COIs in clinical trials reported in journals adhering to the International Committee of Medical Journal Editors’ manuscript guidelines. Self-declared COIs cannot be trusted, but public registries may assist editors in ensuring that more COIs are being reported. PMID:25389230

From randomized controlled trials to observational studies.

PubMed

Silverman, Stuart L

2009-02-01

Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

Depression and Oxidative Stress: Results From a Meta-Analysis of Observational Studies

PubMed Central

Palta, Priya; Samuel, Laura J.; Miller, Edgar R.; Szanton, Sarah L.

2014-01-01

Objective To perform a systematic review and meta-analysis that quantitatively tests and summarizes the hypothesis that depression results in elevated oxidative stress and lower antioxidant levels. Methods We performed a meta-analysis of studies that reported an association between depression and oxidative stress and/or antioxidant status markers. PubMed and EMBASE databases were searched for articles published from January 1980 through December 2012. A random-effects model, weighted by inverse variance, was performed to pool standard deviation (Cohen’s d) effect size estimates across studies for oxidative stress and antioxidant status measures, separately. Results Twenty-three studies with 4980 participants were included in the meta-analysis. Depression was most commonly measured using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria. A Cohen’s d effect size of 0.55 (95% confidence interval = 0.47–0.63) was found for the association between depression and oxidative stress, indicating a roughly 0.55 of 1-standard-deviation increase in oxidative stress among individuals with depression compared with those without depression. The results of the studies displayed significant heterogeneity (I2 = 80.0%, p < .001). A statistically significant effect was also observed for the association between depression and antioxidant status markers (Cohen’s d = −0.24, 95% confidence interval = −0.33 to −0.15). Conclusions This meta-analysis observed an association between depression and oxidative stress and antioxidant status across many different studies. Differences in measures of depression and markers of oxidative stress and antioxidant status markers could account for the observed heterogeneity. These findings suggest that well-established associations between depression and poor heath outcomes may be mediated by high oxidative stress. PMID:24336428

Retrospective study of intravascular large B-cell lymphoma cases diagnosed in Quebec: A retrospective study of 29 case reports.

PubMed

Brunet, Vanessa; Marouan, Sofia; Routy, Jean-Pierre; Hashem, Mohamed Amin; Bernier, Vincent; Simard, Raynald; Petrella, Tony; Lamarre, Louis; Théorêt, Gilles; Carrier, Christian; Knecht, Hans; Fleury, Isabelle; Pavic, Michel

2017-02-01

Intravascular large B-cell lymphoma (IVL) is an extremely rare malignancy, mainly studied through European and Asian series. Due to the low incidence of this condition, our understanding of the clinical presentation as well as the management of IVL relies on a limited number of patients.We report the largest North American study to date on IVL with 29 cases from Quebec hospital diagnosed between 1990 and 2016. The aim of our study is to describe the clinical presentations, diagnostic and staging procedures, therapeutic management and clinical outcomes of IVL patients in our population and compare the disease phenotype to European and Asian series reported.In our cohort, all patients had stage IV IVL at diagnosis, with a median age of 66.7 years (range 47.2-90.8). Clinical presentation was characterized by constitutional symptoms (100%), poor ECOG-PS (100% ≥ 2), cytopenias (93% anemia), and elevated lactate dehydrogenase (97%) and C-reactive protein (96%). Our cohort presented with mainly cutaneous and neurological symptoms. However, neurological involvement (75.9%) was predominant and no "cutaneous variant" was observed; this differs from European literature, where "classical" IVL is reported with mainly cutaneous involvement. Two of our Caucasian patients presented "Asian variant" IVL; this observation is not unusual, as cases of "classical" IVL have been reported in Asians and "Asian variant" IVL has been reported in Europeans. All patients were classified according to their immunophenotypic features in 3 different subgroups (CD5 or CD5CD10, CD5CD10, CD5CD10) with no difference in outcome. Finally, 62% of our cohort received anthracycline-based chemotherapy and 53% of them achieved a complete response. After a median follow-up of 328 days, OS at 3 years was 42.7% for the entire cohort and 47.4% for the cases with in vivo diagnosis. Unlike European studies on "classical" IVL, our study showed that the French Canadian presentation of this subtype of IVL is more

Longitudinal weight gain in women identified with polycystic ovary syndrome: results of an observational study in young women.

PubMed

Teede, Helena J; Joham, Anju E; Paul, Eldho; Moran, Lisa J; Loxton, Deborah; Jolley, Damien; Lombard, Catherine

2013-08-01

Polycystic ovary syndrome (PCOS) affects 6-18% of women. The natural history of weight gain in women with PCOS has not been well described. Here we aimed to examine longitudinal weight gain in women with and without PCOS and to assess the association between obesity and PCOS prevalence. The observational study was set in the general community. Participants were women randomly selected from the national health insurance scheme (Medicare) database. Mailed survey data were collected by the Australian Longitudinal Study on Women's Health. Data from respondents to survey 4, aged 28-33 years (2006, n = 9,145) were analyzed. The main outcome measures were PCOS prevalence and body mass index (BMI). Self-reported PCOS prevalence was 5.8% (95% CI: 5.3%-6.4%). Women reporting PCOS had higher weight, mean BMI [2.5 kg/m(2) (95% CI: 1.9-3.1)], and greater 10-year weight gain [2.6 kg (95% CI: 1.2-4.0)]. BMI was the strongest correlate of PCOS status with every BMI increment increasing the risk of reporting PCOS by 9.2% (95% CI: 6%-12%). This community based observational study with longitudinal reporting of weight shows that weight, BMI, and 10-year weight gain were higher in PCOS. We report the novel finding that obesity and greater weight gain are significantly associated with PCOS status. Considering the prevalence, major health and economic burden of PCOS, the increasing weight gain in young women, and established benefits of weight loss, these results have major public health implications. Copyright © 2012 The Obesity Society.

Beyond the traditional definition of breakthrough pain: an observational study.

PubMed

Gatti, Antonio; Gentili, Marta; Iorno, Vittorio; Mammucari, Massimo; Tufaro, Giuseppe; Lazzari, Marzia; Sabato, Alessandro Fabrizio

2013-03-01

Breakthrough pain (BTP) is traditionally defined as a transitory pain flare in opioid-treated patients with chronic background pain. This definition has, however, been challenged in recent years. This study aimed to analyze BTP prevalence in different pain conditions. This was a prospective, non-interventional, observational study conducted from June to September 2011 in two Italian pain treatment reference centres. Consecutive patients aged >18 years with oncological or non-oncological pain were eligible for this study; background pain was acute/ subacute (<3 months) or chronic (>3 months). The characteristics of pain were evaluated by means of a structured interview by physicians, and patients were asked to complete a dedicated clinical study form. The following outcomes were assessed: chronic pain duration (in patients with chronic pain), BTP prevalence, and number and severity of daily BTP episodes. All outcomes were assessed in four populations of patients with: (a) chronic oncological pain; (b) chronic non-oncological pain; (c) non-chronic oncological pain; (d) non-chronic non-oncological pain. The correlation between BTP and gender was also investigated. Of 1,270 patients with chronic pain, 1,086 had non-oncological pain (85.5%). Most patients (68.6%) with non-oncological pain were female (P = 0.001). Pain duration was significantly longer in non-oncological pain versus oncological pain groups (P = 0.002). BTP prevalence was lower in non-oncological patients (P < 0.001). No differences were reported in terms of number and severity of daily BTP episodes. BTP was more frequent in females with non-oncological pain (P = 0.04). Females had a significantly higher pain severity (P = 0.02) than males. BTP is frequently reported in patients who do not have BTP according to the traditional definition. BTP frequency and severity is similar in oncological and non-oncological pain.

Hospital Use of Observation Stays: Cross-sectional Study of the Impact on Readmission Rates.

PubMed

Venkatesh, Arjun K; Wang, Changqin; Ross, Joseph S; Altaf, Faseeha K; Suter, Lisa G; Vellanky, Smitha; Grady, Jacqueline N; Bernheim, Susannah M

2016-12-01

The Centers for Medicare and Medicaid Services publicly reports hospital risk-standardized readmission rates (RSRRs) as a measure of quality and performance; mischaracterizations may occur because observation stays are not captured by current measures. To describe variation in hospital use of observation stays, the relationship between hospitals observation stay use and RSRRs. Cross-sectional analysis of Medicare fee-for-service beneficiaries discharged after acute myocardial infarction (AMI), heart failure, or pneumonia between July 2011 and June 2012. We calculated 3 hospital-specific 30-day outcomes: (1) observation rate, the proportion of all discharges followed by an observation stay without a readmission; (2) observation proportion, the proportion of observation stays among all patients with an observation stay or readmission; and (3) RSRR. For all 3 conditions, hospitals' observation rates were <2.5% and observation proportions were <12%, although there was variation across hospitals, including 28% of hospital with no observation stay use for AMI, 31% for heart failure, and 43% for pneumonia. There were statistically significant, but minimal, correlations between hospital observation rates and RSRRs: AMI (r=-0.02), heart failure (r=-0.11), and pneumonia (r=-0.02) (P<0.001). There were modest inverse correlations between hospital observation proportion and RSRR: AMI (r=-0.34), heart failure (r=-0.26), and pneumonia (r=-0.21) (P<0.001). If observation stays were included in readmission measures, <4% of top performing hospitals would be recategorized as having average performance. Hospitals' observation stay use in the postdischarge period is low, but varies widely. Despite modest correlation between the observation proportion and RSRR, counting observation stays in readmission measures would minimally impact public reporting of performance.

Mobile App Usage Patterns of Patients Prescribed a Smoking Cessation Medicine: Prospective Observational Study

PubMed Central

2018-01-01

/131, 89.3%) reported being extremely, very, or moderately satisfied with the app. A total of 97 survey respondents (97/131, 74.0%) reported setting up a quit date in the app. Of those, 74 (74/97, 76%) reported quitting on their quit date. Conclusions Positive patient engagement was observed in this study based on app download and usage. This study quantified how the Pfizer Meds app performed in an observational real-world data setting. The findings demonstrate the willingness of participants to set a quit date and use the app for support in medication adherence, refill reminders, and information regarding how to take the medication. This study provides real-world evidence of the contribution apps can make to the continued encouragement of smokers to improve their health by smoking cessation. PMID:29666043

An observational study of the initial management of hypothyroidism in France: the ORCHIDÉE study

PubMed Central

Delemer, Brigitte; Aubert, Jean-Pierre; Nys, Pierre; Landron, Frédéric; Bouée, Stéphane

2012-01-01

Objective To document the initial management of hypothyroidism in France with respect to diagnostic setting, investigations, and therapeutic approach. Design Observational study of the management by primary care practitioners (PCPs) and endocrinologists of patients diagnosed with, and treated for, hypothyroidism during the enrollment period or the previous 6 months. Methods A representative sample of PCPs and endocrinologists enrolled up to five consecutive patients and reported sociodemographic, clinical, therapeutic, and laboratory data. Data were submitted at baseline and at the first measurement of TSH after starting the treatment. Results The analysis population comprised 1255 patients (mean (s.d.) age 52.8 (16.3) years; 84% female). Hypothyroidism was suspected on clinical grounds in 77% of patients, with goiter in 16%. Autoimmune thyroiditis, supported by positive anti-thyroid antibodies, was the most frequent diagnosis (59%), followed by iatrogenic causes (28%), of which thyroidectomy was the most common. The median baseline TSH was 8.6 mIU/l, suggesting a high incidence of subclinical hypothyroidism. Imaging studies were requested in over 75% of patients, with ultrasound performed in 98% and scintigraphy performed in 19% of these patients. Both groups of physicians treated their patients almost exclusively with levothyroxine. Endocrinologists were more likely than PCPs to provide counseling on how to take medication correctly. Conclusions This observational study of a large cohort of patients with newly diagnosed hypothyroidism in France illustrates current practice and indicates some areas where physician education may be required to optimize adherence to guidelines and cost-effectiveness. PMID:23034782

An observational clinical study of the efficacy and tolerability of donepezil in the treatment of Alzheimer's disease.

PubMed

Hager, Klaus; Calabrese, Pasquale; Frölich, Lutz; Göbel, Claus; Berger, Frank M

2003-01-01

An open-label, observational Post-Marketing Surveillance (PMS) study was undertaken in Germany to examine the efficacy and tolerability of donepezil in routine clinical practice. Alzheimer's disease (AD) patients were treated with donepezil (5 or 10 mg once daily) and observed for a period of approximately 3 months. Study assessments included the Mini-Mental State Examination (MMSE), the Nurses' Observation Scale for Geriatric Patients (NOSGER), and adverse events (AEs). A total of 2,092 patients (mean age 73.0 years; mean +/- SD MMSE score 17.8 +/- 5.8) were included in the efficacy assessments. MMSE and NOSGER scores showed statistically significant improvements in the total patient population and in the subpopulations with severe AD or AD with concomitant Parkinsonian symptoms (ADPS cohort). AEs were reported in a total of 12% of patients and were mostly due to peripheral cholinergic effects. In this observational PMS study, donepezil was shown to be an effective and well-tolerated therapy in the overall patient population, in patients with severe AD, and in the ADPS cohort. Copyright 2003 S. Karger AG, Basel

Retention, dosing, tolerability and patient reported seizure outcome of Zonisamide as only add-on treatment under real-life conditions in adult patients with partial onset seizures: Results of the observational study ZOOM.

PubMed

Hamer, Hajo; Baulac, Michel; McMurray, Rob; Kockelmann, Edgar

2016-01-01

Zonisamide is licensed for adjunctive therapy for partial-onset seizures with or without secondary generalisation in patients 6 years and older and as monotherapy for the treatment of partial seizures in adult patients with newly diagnosed epilepsy, and shows a favourable pharmacokinetic profile with low interaction potential with other drugs. The aim of the present study was to gather real-life data on retention and modalities of zonisamide use when administered as only add-on treatment to a current AED monotherapy in adult patients with partial-onset seizures. This multicenter observational study was performed in 4 European countries and comprised three visits: baseline, and after 3 and 6 months. Data on patients' retention, reported efficacy, tolerability and safety, and quality of life was collected. Of 100 included patients, 93 could be evaluated. After 6 months, the retention rate of zonisamide add-on therapy was 82.8%. At this time, a reduction of seizure frequency of at least 50% was observed in 79.7% of patients, with 43.6% reporting seizure freedom over the last 3 months of the study period. Adverse events were reported by 19.4% of patients, with fatigue, agitation, dizziness, and headache being most frequent. Approximately 25% of patients were older than 60 years, many of whom suffered from late-onset epilepsy. Compared to younger patients, these patients showed considerable differences with regard to their antiepileptic drug regimen at baseline, and slightly higher responder and retention rates at 6 months. Despite limitations due to the non-interventional open-label design and the low sample size, the results show that zonisamide as only add-on therapy is well retained, indicating effectiveness in the majority of patients under real-life conditions. Copyright © 2015. Published by Elsevier Ltd.

SABRE observations of Pi2 pulsations: case studies

NASA Astrophysics Data System (ADS)

Bradshaw, E. G.; Lester, M.

1997-01-01

The characteristics of substorm-associated Pi2 pulsations observed by the SABRE coherent radar system during three separate case studies are presented. The SABRE field of view is well positioned to observe the differences between the auroral zone pulsation signature and that observed at mid-latitudes. During the first case study the SABRE field of view is initially in the eastward electrojet, equatorward and to the west of the substorm-enhanced electrojet current. As the interval progresses, the western, upward field-aligned current of the substorm current wedge moves westward across the longitudes of the radar field of view. The westward motion of the wedge is apparent in the spatial and temporal signatures of the associated Pi2 pulsation spectra and polarisation sense. During the second case study, the complex field-aligned and ionospheric currents associated with the pulsation generation region move equatorward into the SABRE field of view and then poleward out of it again after the third pulsation in the series. The spectral content of the four pulsations during the interval indicate different auroral zone and mid-latitude signatures. The final case study is from a period of low magnetic activity when SABRE observes a Pi2 pulsation signature from regions equatorward of the enhanced substorm currents. There is an apparent mode change between the signature observed by SABRE in the ionosphere and that on the ground by magnetometers at latitudes slightly equatorward of the radar field of view. The observations are discussed in terms of published theories of the generation mechanisms for this type of pulsation. Different signatures are observed by SABRE depending on the level of magnetic activity and the position of the SABRE field of view relative to the pulsation generation region. A twin source model for Pi2 pulsation generation provides the clearest explanation of the signatures observed Acknowledgements. The authors are grateful to Prof. D. J. Southwood

Empirical Performance of Covariates in Education Observational Studies

ERIC Educational Resources Information Center

Wong, Vivian C.; Valentine, Jeffrey C.; Miller-Bains, Kate

2017-01-01

This article summarizes results from 12 empirical evaluations of observational methods in education contexts. We look at the performance of three common covariate-types in observational studies where the outcome is a standardized reading or math test. They are: pretest measures, local geographic matching, and rich covariate sets with a strong…

"Lies, damned lies ..." and observational studies in comparative effectiveness research.

PubMed

Albert, Richard K

2013-06-01

A new federal initiative has allocated $1.1 billion to comparative effectiveness research, and many have emphasized the importance of including observational studies in this effort. The rationale for using observational studies to assess comparative effectiveness is based on concerns that randomized controlled trials (RCTs) are not "real world" because they enroll homogeneous patient populations, measure study outcomes that are not important to patients, use protocols that are overly complex, are conducted in specialized centers, and use study treatments that are not consistent with usual care, and that RCTs are not always feasible because of a lack of equipoise, the need to assess delayed endpoints, and concerns that they take years to complete and are expensive. This essay questions the validity of each of these proposed limitations, summarizes concerns raised about the accuracy of results generated by observational studies, provides some examples of discrepancies between results of observational studies and RCTs that pertain to pulmonary and critical care, and suggests that using observational studies for comparative effectiveness research may increase rather than decrease the cost of health care and may harm patients.

Candidate configuration trade study, Stellar-inertial Measurement Systems (SIMS) for an Earth Observation Satellite (EOS)

NASA Technical Reports Server (NTRS)

Ogletree, G.; Coccoli, J.; Mckern, R.; Smith, M.; White, R.

1972-01-01

The results of analytical and simulation studies of the stellar-inertial measurement system (SIMS) for an earth observation satellite are presented. Subsystem design analyses and sensor design trades are reported. Three candidate systems are considered: (1) structure-mounted gyros with structure-mounted star mapper, (2) structure-mounted gyros with gimbaled star tracker, and (3) gimbaled gyros with structure-mounted star mapper. The purpose of the study is to facilitate the decisions pertaining to gimbaled versus structure-mounted gyros and star sensors, and combinations of systems suitable for the EOS satellite.

An Observational Study of Antibiotic Prescribing Behavior and the Hawthorne Effect

PubMed Central

Mangione-Smith, Rita; Elliott, Marc N; McDonald, Laurie; McGlynn, Elizabeth A

2002-01-01

Objectives To assess whether prospective, observational study procedures, including questionnaires and audio recording, are associated with different patterns of physician diagnostic decision making and antibiotic prescribing. Data Sources/Setting (1) Survey data from a prospective observational study of treatment patterns for children with acute upper respiratory illnesses (10/96–3/97) and (2) retrospective medical record abstraction data of nonobserved encounters for the same problems occurring during (10/96–3/97) and one year after (10/97–3/98) the observational study period. Ten pediatricians in two community practices were studied. Study Design Patterns of diagnoses recorded in the medical record and antibiotics ordered for visits occurring outside of the observational study (same time period and one year later) were compared with the pattern of diagnoses and antibiotics ordered during the observational study. Data Collection/Extraction Methods For the observational study (10/96–2/97), diagnosis and treatment choices were obtained from questionnaires completed by physicians immediately following the visit. For the nonstudy encounters (10/96–3/97 and 10/97–3/98), data were abstracted from medical records one year after the observational study was completed. Principal Findings The proportion of viral cases in which an antibiotic was prescribed was 29 percentage points lower for the observational study compared to the retrospective analysis (p <.05). In one of two study sites, the proportion of cases assigned a bacterial diagnosis was 29 percentage points lower in the observational study period compared to the retrospective study (p <.05). Conclusions Observational study procedures including questionnaires and audio recording can affect antibiotic prescribing behavior. Future observational studies aimed at examining the frequency of inappropriate antibiotic prescribing should measure and adjust for the Hawthorne effect; without such adjustments, the

Identifying Opportunities for Peer Learning: An Observational Study of Medical Students on Clinical Placements.

PubMed

Tai, Joanna H; Canny, Benedict J; Haines, Terry P; Molloy, Elizabeth K

2017-01-01

Phenomenon: Peer assisted learning (PAL) is frequently employed and researched in preclinical medical education. Fewer studies have examined PAL in the clinical context: These have focused mainly on the accuracy of peer assessment and potential benefits to learner communication and teamwork skills. Research has also examined the positive and negative effects of formal, structured PAL activities in the clinical setting. Given the prevalence of PAL activities during preclinical years, and the unstructured nature of clinical placements, it is likely that nonformal PAL activities are also undertaken. How PAL happens formally and informally and why students find PAL useful in this clinical setting remain poorly understood. This study aimed to describe PAL activities within the context of clinical placement learning and to explore students' perceptions of these activities. An ethnographic study was conducted to gather empirical data on engagement in clinical placement learning activities, including observations and interviews with students in their 1st clinical year, along with their supervising clinicians. Thematic analysis was used to interrogate the data. On average, students used PAL for 5.19 hours per week in a range of activities, of a total of 29.29 hours undertaking placements. PAL was recognized as a means of vicarious learning and had greater perceived value when an educator was present to guide or moderate the learning. Trust between students was seen as a requirement for PAL to be effective. Students found passive observation a barrier to PAL and were able to identify ways to adopt an active stance when observing peers interacting with patients. For example, learners reported that the expectation that they had to provide feedback to peers after task observation, resulted in them taking on a more critical gaze where they were encouraged to consider notions of good practice. Insights: Students use PAL in formal (i.e., tutorial) and nonformal (e.g., peer

Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study.

PubMed

Cameron, Anne P; Lewicky-Gaupp, Christina; Smith, Abigail R; Helfand, Brian T; Gore, John L; Clemens, J Quentin; Yang, Claire C; Siddiqui, Nazema Y; Lai, H Henry; Griffith, James W; Andreev, Victor P; Liu, Gang; Weinfurt, Kevin; Amundsen, Cindy L; Bradley, Catherine S; Kusek, John W; Kirkali, Ziya

2018-04-01

We described and compared the frequency and type of lower urinary tract symptoms reported by men and women at the time that they were recruited from urology and urogynecology clinics into the Symptoms of Lower Urinary Tract Dysfunction Research Network multicenter, prospective, observational cohort study. At 6 research sites treatment seeking men and women were enrolled who reported any lower urinary tract symptoms at a frequency more than rarely during the last month on the LUTS (Lower Urinary Tract Symptoms) Tool. At baseline the study participants underwent a standardized clinical evaluation and completed validated questionnaires. Urological tests were performed, including pelvic/rectal examination, post-void residual urine measurement and urinalysis. A total of 545 women and 519 men were enrolled in the study. Mean ± SD age was 58.8 ± 14.1 years. At baseline nocturia, frequency and a sensation of incomplete emptying were similar in men and women but men experienced more voiding symptoms (90% vs 85%, p = 0.007) and women reported more urgency (85% vs 66%, p <0.001). Women also reported more of any type of urinary incontinence than men (82% vs 51% p <0.001), which was mixed incontinence in 57%. Only 1% of men reported stress incontinence but they had other urinary incontinence, including post-void dribbling in 44% and urgency incontinence in 46%. Older participants had higher odds of reporting symptoms of nocturia and urgency. In this large, treatment seeking cohort of men and women lower urinary tract symptoms varied widely by gender and age. Men reported more voiding symptoms and nonstress or urgency urinary incontinence while women reported more incontinence overall and urgency. Older participants had greater odds of urgency and nocturia. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Observed emotion frequency versus intensity as predictors of socioemotional maladjustment.

PubMed

Hernández, Maciel M; Eisenberg, Nancy; Valiente, Carlos; Spinrad, Tracy L; VanSchyndel, Sarah K; Diaz, Anjolii; Berger, Rebecca H; Silva, Kassondra M; Southworth, Jody; Piña, Armando A

2015-12-01

The purpose of this study was to assess whether observed emotional frequency (the proportion of instances an emotion was observed) and intensity (the strength of an emotion when it was observed) uniquely predicted kindergartners' (N = 301) internalizing and externalizing problems. Analyses were tested in a structural equation modeling (SEM) framework with data from multireporters (reports of problem behaviors from teachers and parents) and naturalistic observations of emotion in the fall semester. For observed positive emotion, both frequency and intensity negatively predicted parent- or teacher-reported internalizing symptoms. Anger frequency positively predicted parent- and teacher-reported externalizing symptoms, whereas anger intensity positively predicted parent- and teacher-reported externalizing and parent-reported internalizing symptoms. The findings support the importance of examining both aspects of emotion when predicting maladjustment. (c) 2015 APA, all rights reserved).

A roadside study of observable driver distractions.

PubMed

Sullman, Mark J M; Prat, Francesc; Tasci, Duygu Kuzu

2015-01-01

This study investigated the prevalence of observable distractions while driving and the effect of drivers' characteristics and time-related variables on their prevalence. Using roadside observation, 2 independent observers collected data at 4 randomly selected locations in St. Albans, UK. Of the 10,984 drivers observed, 16.8% were engaged in a secondary task, with talking to passengers being the most common distraction (8.8%), followed by smoking (1.9%) and talking on a hands-free mobile phone (1.7%). An additional 1.0% were observed talking on a handheld phone, and the rest of the distractions (e.g., texting, drinking) were recorded in less than 1% of the drivers observed. Gender-related differences were found for a number of different distractions (i.e., talking to passengers, drinking, and handheld mobile phone conversations), but age emerged as a significant predictor for most secondary tasks, including talking to passengers, smoking, hands-free mobile phone use, handheld mobile phone use, texting/keying numbers, drinking, and engagement in any type of distraction (all distractions combined). The overall pattern for age was that middle-aged and older drivers were less likely to be distracted than younger drivers. This work provides further evidence of the relatively high rate of distracted driving in the UK. The findings clearly indicate that younger drivers are more likely to drive distracted, which probably contributes to their higher crash rates.

How to report a research study.

PubMed

Cronin, Paul; Rawson, James V; Heilbrun, Marta E; Lee, Janie M; Kelly, Aine M; Sanelli, Pina C; Bresnahan, Brian W; Paladin, Angelisa M

2014-09-01

Incomplete reporting hampers the evaluation of results and bias in clinical research studies. Guidelines for reporting study design and methods have been developed to encourage authors and journals to include the required elements. Recent efforts have been made to standardize the reporting of clinical health research including clinical guidelines. In this article, the reporting of diagnostic test accuracy studies, screening studies, therapeutic studies, systematic reviews and meta-analyses, cost-effectiveness assessments (CEA), recommendations and/or guidelines, and medical education studies is discussed. The available guidelines, many of which can be found at the Enhancing the QUAlity and Transparency Of health Research network, on how to report these different types of health research are also discussed. We also hope that this article can be used in academic programs to educate the faculty and trainees of the available resources to improve our health research. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

The BraveNet prospective observational study on integrative medicine treatment approaches for pain

PubMed Central

2013-01-01

Background Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. Methods Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. Results Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (−23%) and interference (−28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. Conclusions Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. Trial Registration ClinicalTrials.gov, NCT

Particle-Laden Leidenfrost Droplets: Final-Stage Observations

NASA Astrophysics Data System (ADS)

Fang, Zecong; Xu, Jie

2015-03-01

Little interest has been paid to the final stage of a Leidenfrost droplet until a recent study by Celestini et al [Phys. Rev. Lett. 109, 034501 (2012)] reporting an unexpected take-off phenomenon of micrometer sized pure liquid droplets (Rl < R study, we first report an unexpected observation on millimeter sized water Leidenfrost droplets (R >Ri), which behave quite differently from the previous study. While an originally micrometer sized Leidenfrost droplet takes off due to breakdown of lubrication regime, and hovers above its vapor layer until disappearing in the final stage of evaporation, an originally millimetric Leidenfrost drop is observed to hover and oscillate, taking off and falling back consecutively. We further report another interesting observation on water droplets containing micrometric glass beads. These droplets spontaneously organize and buckle together during evaporation. In addition to oscillation just like pure droplets, these particle-laden drops create an unexpected explosive shoot-up at the end of evaporation.

AVTA Federal Fleet PEV Readiness Data Logging and Characterization Study: Final Report

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

Schey, Stephen; Francfort, Jim

2015-06-01

Collect and evaluate data on federal fleet operations as part of the Advanced Vehicle Testing Activity’s Federal Fleet Vehicle Data Logging and Characterization Study. The Advanced Vehicle Testing Activity study seeks to collect and evaluate data to validate the utilization of advanced plug-in electric vehicle (PEV) transportation. This report summarizes the fleets studied to identify daily operational characteristics of select vehicles and report findings on vehicle and mission characterizations to support the successful introduction of PEVs into the agencies’ fleets. Individual observations of these selected vehicles provide the basis for recommendations related to electric vehicle adoption and whether a batterymore » electric vehicle or plug-in hybrid electric vehicle (collectively referred to as PEVs) can fulfill the mission requirements.« less

Estimation of Biota Sediment Accumulation Factor (BSAF) from Paired Observations of Chemical Concentrations in Biota and Sediment (Final Report)

EPA Science Inventory

In March 2009, EPA's Ecological Risk Assessment Support Center (ERASC) released the final report entitled, Estimation of Biota Sediment Accumulation Factor (BSAF) from Paired Observations of Chemical Concentrations in Biota and Sediment. This report was written in response...

An Observational Study of Skilled Memory in Waitresses.

ERIC Educational Resources Information Center

Stevens, Joy

A two-phase study about skilled memory as it is used by waitresses included a participant-observer phase and an observational phase. Participants were three experienced waitresses who had worked at a midtown Manhattan restaurant for 14, 7, and 3 years respectively and a team of 5 confederate customers. Waitresses and customers wore microphones.…

The NOAA Satellite Observing System Architecture Study

NASA Technical Reports Server (NTRS)

Volz, Stephen; Maier, Mark; Di Pietro, David

2016-01-01

NOAA is beginning a study, the NOAA Satellite Observing System Architecture (NSOSA) study, to plan for the future operational environmental satellite system that will follow GOES and JPSS, beginning about 2030. This is an opportunity to design a modern architecture with no pre-conceived notions regarding instruments, platforms, orbits, etc. The NSOSA study will develop and evaluate architecture alternatives to include partner and commercial alternatives that are likely to become available. The objectives will include both functional needs and strategic characteristics (e.g., flexibility, responsiveness, sustainability). Part of this study is the Space Platform Requirements Working Group (SPRWG), which is being commissioned by NESDIS. The SPRWG is charged to assess new or existing user needs and to provide relative priorities for observational needs in the context of the future architecture. SPRWG results will serve as input to the process for new foundational (Level 0 and Level 1) requirements for the next generation of NOAA satellites that follow the GOES-R, JPSS, DSCOVR, Jason-3, and COSMIC-2 missions.

Excess mortality associated with hypopituitarism in adults: a meta-analysis of observational studies.

PubMed

Pappachan, Joseph M; Raskauskiene, Diana; Kutty, V Raman; Clayton, Richard N

2015-04-01

Several previous observational studies showed an association between hypopituitarism and excess mortality. Reports on reduction of standard mortality ratio (SMR) with GH replacement have been published recently. This meta-analysis assessed studies reporting SMR to clarify mortality risk in hypopituitary adults and also the potential benefit conferred by GH replacement. A literature search was performed in Medline, Embase, and Cochrane library up to March 31, 2014. Studies with or without GH replacement reporting SMR with 95% confidence intervals (95% CI) were included. Patient characteristics, SMR data, and treatment outcomes were independently assessed by two authors, and with consensus from third author, studies were selected for analysis. Meta-analysis was performed in all studies together, and those without and with GH replacement separately, using the statistical package metafor in R. Six studies reporting a total of 19 153 hypopituiatary adults with a follow-up duration of more than 99,000 person years were analyzed. Hypopituitarism was associated with an overall excess mortality (weighted SMR, 1.99; 95% CI, 1.21-2.76) in adults. Female hypopituitary adults showed higher SMR compared with males (2.53 vs 1.71). Onset of hypopituitarism at a younger age was associated with higher SMR. GH replacement improved the mortality risk in hypopituitary adults that is comparable to the background population (SMR with GH replacement, 1.15; 95% CI, 1.05-1.24 vs SMR without GH, 2.40; 95% CI, 1.46-3.34). GH replacement conferred lower mortality benefit in hypopituitary women compared with men (SMR, 1.57; 95% CI, 1.38-1.77 vs 0.95; 95% CI, 0.85-1.06). There was a potential selection bias of benefit of GH replacement from a post-marketing data necessitating further evidence from long-term randomized controlled trials. Hypopituitarism may increase premature mortality in adults. Mortality benefit from GH replacement in hypopituitarism is less pronounced in women than men.

Climate observing system studies: An element of the NASA Climate Research Program: Workshop report

NASA Technical Reports Server (NTRS)

1980-01-01

Plans for NASA's efforts in climatology were discussed. Targets for a comprehensive observing system for the early 1990's were considered. A program to provide useful data in the near and mid-term, and a program to provide for a feasibility assessment of instruments and methods for the development of a long-term system were discussed. Climate parameters that cannot be measured from space were identified. Long-term calibration, intercomparison, standards, and ground truth were discussed.

Community Engagement in Observational Human Exposure Studies

EPA Science Inventory

Although observational human exposure studies do not deliberately expose participants to chemicals or environmental conditions, merely involving people as research participants and conducting research inside homes raises ethical issues. Community engagement offers a promising st...

Do research studies in the UK reporting child neurodevelopment adjust for the variability of assessors: a systematic review.

PubMed

Khalid, Rahila; Willatts, Peter; Williams, Fiona L R

2016-02-01

Neurodevelopment is a key outcome for many childhood trials and observational studies. Clinically important decisions may rest on finding relatively small differences in neurodevelopment between groups receiving complex and costly interventions. Our purpose was to determine whether studies which measure neurodevelopment report the numbers, training, and auditing of assessors and, for multiple assessor studies, whether the results were adjusted and if so by which method? Electronic searches were conducted using Medline, Embase, Cinahl, PsycINFO, and the Cochrane Library. A study was eligible if it reported neurodevelopmental outcome in children resident in the UK, less than or equal to 18 years and was published between 2000 and 2015. Trials and observational studies were included. Three hundred and seven full papers were reviewed: 52% of papers did not report the number of assessors used; 21% used a single assessor; and 27% used multiple assessors. Thirty-five per cent mentioned that assessors were trained in the use of the neurodevelopmental tool; 13% of assessors were audited; and only 1% of studies adjusted statistically for the number of assessors. At the very least, the quality of reporting the use of assessors in these research publications is poor, while at worst, the variability of assessors may mask the true relationship between an intervention/observation and neurodevelopmental outcome. © 2015 Mac Keith Press.

Long-term dose-response studies of inhaled or injected radionuclides. Biennial report, 1 October 1991--30 September 1993

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

Boecker, B.B.; Muggenburg, B.A.; Miller, S.C.

This report describes the scientific progress in, and current status of, life-span studies of the long-term health risks in Beagle dogs of chronic irradiation from internally deposited radionuclides or from an external source. The reporting period for this document is the 2-year period from October 1, 1991 through September 30, 1993. Studies that were initiated at three different laboratories (Inhalation Toxicology Research Institute, ITRI, University of Utah, and Argonne National Laboratory, ANL) are presented here because they are being completed at ITRI. All living dogs in the Utah-initiated studies were transferred to the ITRI facility for the remainder of theirmore » life-span observations and measurements in September 1987. This report is the fourth in a series of reports dealing with the current status and progress of both the Utah and ITRI studies. Other life-span studies involving dogs exposed to gamma radiation from an external source were initiated and conducted for many years at ANL. In 1991, the decision was made to discontinue the chronic irradiation of the remaining living dogs and to transfer all remaining dogs to ITRI for care, clinical observations, and pathological observations at death or euthanasia. This report provides the current status of these dogs. Status reports on the Utah and ITRI studies comprise most of this report. The ITRI-related section presents brief statements of project objectives, the general procedures used in these studies, and some study-specific features for each of the 19 studies being conducted with either beta- or alpha-emitting radionuclides. Dose- and effect-modifying factors being addressed in these studies include total dose, dose rate, LET, solubility, nonuniformity of dose, species, age, sex, health status, and mode of exposure. Recent additions to experimental protocols for studies in which dogs are still alive involve the collection and analysis of tumor tissues using currently available molecular biology

Recognition of out-of-hospital cardiac arrest during emergency calls - a systematic review of observational studies.

PubMed

Viereck, Søren; Møller, Thea Palsgaard; Rothman, Josephine Philip; Folke, Fredrik; Lippert, Freddy Knudsen

2017-02-01

The medical dispatcher plays an essential role as part of the first link in the Chain of Survival, by recognising the out-of-hospital cardiac arrest (OHCA) during the emergency call, dispatching the appropriate first responder or emergency medical services response, performing dispatcher assisted cardiopulmonary resuscitation, and referring to the nearest automated external defibrillator. The objective of this systematic review was to evaluate and compare studies reporting recognition of OHCA patients during emergency calls. This systematic review was reported in compliance with the PRISMA guidelines. We systematically searched MEDLINE, Embase and the Cochrane Library on 4 November 2015. Observational studies, reporting the proportion of clinically confirmed OHCAs that was recognised during the emergency call, were included. Two authors independently screened abstracts and full-text articles for inclusion. Data were extracted and the risk of bias within studies was assessed using the QUADAS-2 tool for quality assessment of diagnostic accuracy studies. A total of 3,180 abstracts were screened for eligibility and 53 publications were assessed in full-text. We identified 16 studies including 6,955 patients that fulfilled the criteria for inclusion in the systematic review. The studies reported recognition of OHCA with a median sensitivity of 73.9% (range: 14.1-96.9%). The selection of study population and the definition of "recognised OHCA" (threshold for positive test) varied greatly between the studies, resulting in high risk of bias. Heterogeneity in the studies precluded meta-analysis. Among the 16 included studies, we found a median sensitivity for OHCA recognition of 73.9% (range: 14.1-96.9%). However, great heterogeneity between study populations and in the definition of "recognised OHCA", lead to insufficient comparability of results. Uniform and transparent reporting is required to ensure comparability and development towards best practice.

Trends in Condom Use and Risk Behaviours after Sexual Exposure to HIV: A Seven-Year Observational Study

PubMed Central

Casalino, Enrique; Choquet, Christophe; Leleu, Agathe; Hellmann, Romain; Wargon, Mathias; Juillien, Gaelle; Yazdanpanah, Yazdan; Bouvet, Elisabeth

2014-01-01

Objective We aimed to determine the trends in numbers and percentages of sexually exposed persons to HIV (SE) consulting an ED for post-exposure prophylaxis (PEP), as well as predictors of condom use. Study Design We conducted a prospective-observational study. Methods We included all SE attendances in our Emergency Department (ED) during a seven-year study-period (2006–2012). Trends were analyzed using time-series analysis. Logistic Regression was used to define indicators of condom use. Results We enrolled 1851 SE: 45.7% reported intercourse without condom-use and 12.2% with an HIV-infected partner. Significant (p<0.01) rising trends were observed in the overall number of SE visits (+75%), notably among men having sex with men (MSM) (+126%). There were rising trends in the number and percentage of those reporting intercourse without condom-use in the entire population +91% (p<0.001) and +1% (p>0.05), in MSM +228% (p<0.001) and +49% (p<0.001), in Heterosexuals +68% (p<0.001) and +10% (p = 0.08). Among MSM, significant rising trends were found in those reporting high-risk behaviours: anal receptive (+450% and +76%) and anal insertive (+l33% and +70%) intercourses. In a multivariate logistic regression analysis, heterosexuals, vaginal intercourse, visit during the night-shift and short time delay between SE and ED visit, were significantly associated with condom-use. Conclusion We report an increasing trend in the number of SE, mainly among MSM, and rising trends in high-risk behaviours and unprotected sexual intercourses among MSM. Our results indicate that SE should be considered as a high-risk population for HIV and sexually transmitted diseases. PMID:25157477

The advances in airglow study and observation by the ground-based airglow observation network over China

NASA Astrophysics Data System (ADS)

Xu, Jiyao; Li, Qinzeng; Yuan, Wei; Liu, Xiao; Liu, Weijun; Sun, Longchang

2017-04-01

Ground-based airglow observation networks over China used to study airglow have been established, which contains 15 stations. Some new results were obtained using the networks. For OH airglow observations, firstly, an unusual outbreak of Concentric Gravity Wave (CGW) events were observed by the first no-gap network nearly every night during the first half of August 2013. Combination of the ground imager network with satellites provides multilevel observations of the CGWs from the troposphere to the mesopause region. Secondly, three-year OH airglow images (2012-2014) from Qujing (25.6°N, 103.7°E) were used to study how orographic features of the Tibetan Plateau (TP) affect the geographical distributions of gravity wave (GW) sources. We find the orographic forcings have a significant impact on the gravity wave propagation features. Thirdly, ground-based observations of the OH (9-4, 8-3, 6-2, 5-1, 3-0) band airglow over Xinglong (40°2N, 117°4E) in northern China from 2012 to 2014 are used to calculate rotational temperatures. By comparing the ground-based OH rotational temperature with SABER's observations, five Einstein coefficient datasets are evaluated. We find rotational temperatures determined using any of the available Einstein coefficient datasets have systematic errors. We have obtained a set of optimal Einstein coefficients ratios for rotational temperature derivation using three years data from ground-based OH spectra and SABER temperatures. For the OI 630.0 nm airglow observations, we used three-year (2011-2013) observations of thermospheric winds (at 250 km) by Fabry-Perot interferometers at Xinglong to study the climatology of atmospheric planetary wave-type oscillations (PWTOs) with periods of 4-19 days. We found these PWTOs occur more frequently in the months from May to October. They are consistent with the summertime preference of middle-latitude ionospheric electron density oscillations noted in other studies. By using an all-sky airglow imager

Effects of self-reported age at nonsurgical menopause on time to first fracture and bone mineral density in the Women's Health Initiative Observational Study.

PubMed

Sullivan, Shannon D; Lehman, Amy; Thomas, Fridtjof; Johnson, Karen C; Jackson, Rebecca; Wactawski-Wende, Jean; Ko, Marcia; Chen, Zhao; Curb, J David; Howard, Barbara V

2015-10-01

Menopause is a risk factor for fracture; thus, menopause age may affect bone mass and fracture rates. We compared bone mineral density (BMD) and fracture rates among healthy postmenopausal women with varying ages at self-reported nonsurgical menopause. We compared hazard ratios for fractures and differences in BMD among 21,711 postmenopausal women from the Women's Health Initiative Observational Study cohort who had no prior hysterectomy, oophorectomy, or hormone therapy and had varying self-reported ages at menopause (<40, 40-49, or ≥50 y). Before multivariable adjustments, we found no differences in absolute fracture risk among menopause age groups. After multivariable adjustments for known risk factors for fracture, women who underwent menopause before age 40 years had a higher fracture risk at any site compared with women who underwent menopause at age 50 years or older (hazard ratio, 1.21; 95% CI, 1.02 to 1.44; P = 0.03). In a subset with BMD measurements (n = 1,351), whole-body BMD was lower in women who reported menopause before age 40 years than in women who reported menopause at ages 40 to 49 years (estimated difference, -0.034 g/cm; 95% CI, -0.07 to -0.004; P = 0.03) and women who reported menopause at age 50 years or older (estimated difference, -0.05 g/cm; 95% CI, -0.08 to -0.02; P < 0.01). Left hip BMD was lower in women who underwent menopause before age 40 years than in women who underwent menopause at age 50 years or older (estimated difference, -0.05 g/cm; 95% CI, -0.08 to -0.01; P = 0.01), and total spine BMD was lower in women who underwent menopause before age 40 years than in women who underwent menopause at age 50 years or older (estimated difference, -0.11 g/cm; 95% CI, -0.16 to -0.06; P < 0.01) and women who underwent menopause at ages 40 to 49 years (estimated difference, -0.09 g/cm; 95% CI, -0.15 to -0.04; P < 0.01). In the absence of hormone therapy, younger age at menopause may be a risk factor

Poor replication validity of biomedical association studies reported by newspapers

PubMed Central

Smith, Andy; Boraud, Thomas; Gonon, François

2017-01-01

Objective To investigate the replication validity of biomedical association studies covered by newspapers. Methods We used a database of 4723 primary studies included in 306 meta-analysis articles. These studies associated a risk factor with a disease in three biomedical domains, psychiatry, neurology and four somatic diseases. They were classified into a lifestyle category (e.g. smoking) and a non-lifestyle category (e.g. genetic risk). Using the database Dow Jones Factiva, we investigated the newspaper coverage of each study. Their replication validity was assessed using a comparison with their corresponding meta-analyses. Results Among the 5029 articles of our database, 156 primary studies (of which 63 were lifestyle studies) and 5 meta-analysis articles were reported in 1561 newspaper articles. The percentage of covered studies and the number of newspaper articles per study strongly increased with the impact factor of the journal that published each scientific study. Newspapers almost equally covered initial (5/39 12.8%) and subsequent (58/600 9.7%) lifestyle studies. In contrast, initial non-lifestyle studies were covered more often (48/366 13.1%) than subsequent ones (45/3718 1.2%). Newspapers never covered initial studies reporting null findings and rarely reported subsequent null observations. Only 48.7% of the 156 studies reported by newspapers were confirmed by the corresponding meta-analyses. Initial non-lifestyle studies were less often confirmed (16/48) than subsequent ones (29/45) and than lifestyle studies (31/63). Psychiatric studies covered by newspapers were less often confirmed (10/38) than the neurological (26/41) or somatic (40/77) ones. This is correlated to an even larger coverage of initial studies in psychiatry. Whereas 234 newspaper articles covered the 35 initial studies that were later disconfirmed, only four press articles covered a subsequent null finding and mentioned the refutation of an initial claim. Conclusion Journalists

Poor replication validity of biomedical association studies reported by newspapers.

PubMed

Dumas-Mallet, Estelle; Smith, Andy; Boraud, Thomas; Gonon, François

2017-01-01

To investigate the replication validity of biomedical association studies covered by newspapers. We used a database of 4723 primary studies included in 306 meta-analysis articles. These studies associated a risk factor with a disease in three biomedical domains, psychiatry, neurology and four somatic diseases. They were classified into a lifestyle category (e.g. smoking) and a non-lifestyle category (e.g. genetic risk). Using the database Dow Jones Factiva, we investigated the newspaper coverage of each study. Their replication validity was assessed using a comparison with their corresponding meta-analyses. Among the 5029 articles of our database, 156 primary studies (of which 63 were lifestyle studies) and 5 meta-analysis articles were reported in 1561 newspaper articles. The percentage of covered studies and the number of newspaper articles per study strongly increased with the impact factor of the journal that published each scientific study. Newspapers almost equally covered initial (5/39 12.8%) and subsequent (58/600 9.7%) lifestyle studies. In contrast, initial non-lifestyle studies were covered more often (48/366 13.1%) than subsequent ones (45/3718 1.2%). Newspapers never covered initial studies reporting null findings and rarely reported subsequent null observations. Only 48.7% of the 156 studies reported by newspapers were confirmed by the corresponding meta-analyses. Initial non-lifestyle studies were less often confirmed (16/48) than subsequent ones (29/45) and than lifestyle studies (31/63). Psychiatric studies covered by newspapers were less often confirmed (10/38) than the neurological (26/41) or somatic (40/77) ones. This is correlated to an even larger coverage of initial studies in psychiatry. Whereas 234 newspaper articles covered the 35 initial studies that were later disconfirmed, only four press articles covered a subsequent null finding and mentioned the refutation of an initial claim. Journalists preferentially cover initial findings

Impulsivity-hyperactivity and subtypes of aggression in early childhood: an observational and short-term longitudinal study.

PubMed

Ostrov, Jamie M; Godleski, Stephanie A

2009-08-01

This short-term longitudinal study (N = 112) was conducted to explore the concurrent and prospective associations between teacher-reported impulsive-hyperactive behavior and observed relational and physical aggression during early childhood (M = 45.54 months old, SD = 9.07). Multiple informants and methods including observational methods (i.e., 160 min per child) were used to assess aggression and impulsivity-hyperactivity. All measures were found to be valid and reliable. Prospective hierarchical regression analyses revealed that impulsivity-hyperactivity was associated with increases in observed physical aggression across time, controlling for initial relational aggression and gender. These findings add to the growing developmental psychopathology literature that suggests that distinguishing between subtypes of aggression during early childhood may be important for understanding the course of impulsivity-hyperactivity in young children. Implications for practice are discussed.

Torrejon AB, Madrid, Spain. revised uniform summary of surface weather observations (RUSSWO). parts a-f. Final report

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

Not Available

1978-10-03

This report is a six-part statistical summary of surface weather observations for Torrejon AB, Madrid Spain. It contains the following parts: (A) Weather Conditions; Atmospheric Phenomena; (B) Precipitation, Snowfall and Snow Depth (daily amounts and extreme values); (C) Surface winds; (D) Ceiling Versus Visibility; Sky Cover; (E) Psychrometric Summaries (daily maximum and minimum temperatures, extreme maximum and minimum temperatures, psychrometric summary of wet-bulb temperature depression versus dry-bulb temperature, means and standard deviations of dry-bulb, wet-bulb and dew-point temperatures and relative humidity); and (F) Pressure Summary (means, standard, deviations, and observation counts of station pressure and sea-level pressure). Data in thismore » report are presented in tabular form, in most cases in percentage frequency of occurrence or cumulative percentage frequency of occurrence tables.« less

The effect of wind turbine noise on sleep and quality of life: A systematic review and meta-analysis of observational studies.

PubMed

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

2015-09-01

Noise generated by wind turbines has been reported to affect sleep and quality of life (QOL), but the relationship is unclear. Our objective was to explore the association between wind turbine noise, sleep disturbance and quality of life, using data from published observational studies. We searched Medline, Embase, Global Health and Google Scholar databases. No language restrictions were imposed. Hand searches of bibliography of retrieved full texts were also conducted. The reporting quality of included studies was assessed using the STROBE guidelines. Two reviewers independently determined the eligibility of studies, assessed the quality of included studies, and extracted the data. We included eight studies with a total of 2433 participants. All studies were cross-sectional, and the overall reporting quality was moderate. Meta-analysis of six studies (n=2364) revealed that the odds of being annoyed is significantly increased by wind turbine noise (OR: 4.08; 95% CI: 2.37 to 7.04; p<0.00001). The odds of sleep disturbance was also significantly increased with greater exposure to wind turbine noise (OR: 2.94; 95% CI: 1.98 to 4.37; p<0.00001). Four studies reported that wind turbine noise significantly interfered with QOL. Further, visual perception of wind turbine generators was associated with greater frequency of reported negative health effects. In conclusion, there is some evidence that exposure to wind turbine noise is associated with increased odds of annoyance and sleep problems. Individual attitudes could influence the type of response to noise from wind turbines. Experimental and observational studies investigating the relationship between wind turbine noise and health are warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

In-Hospital Recruitment to Observational Studies of Stroke

ERIC Educational Resources Information Center

Pickering, Ruth M.; Kunkel, Dorit; Fitton, Carolyn; Ashburn, Ann; Jenkinson, Damian

2010-01-01

The objective of this study was to examine recruitment in three observational follow-up studies of patients with stroke, focusing on reasons for nonparticipation and the role of potential factors in explaining recruitment rates. It comprised secondary analysis of the three studies. Recruitment rates varied between the studies. Between 10 and 50%…

A cross sectional observational study of research activity of allied health teams: is there a link with self-reported success, motivators and barriers to undertaking research?

PubMed

Wenke, Rachel J; Mickan, Sharon; Bisset, Leanne

2017-02-06

Team-based approaches to research capacity building (RCB) may be an efficient means to promote allied health research participation and activity. In order to tailor such interventions, a clearer understanding of current patterns of research participation within allied health teams is needed. Different self-report measures exist which evaluate a team's research capacity and participation, as well as associated barriers and motivators. However, it remains unclear how such measures are associated with a team's actual research activity (e.g., journal publications, funding received). In response, this observational study aimed to identify the research activity, self-reported success, and motivations and barriers to undertaking research of eight allied health professional (AHP) teams and to explore whether any relationships exist between the self-reported measures and actual research activity within each team. A total of 95 AHPs from eight teams completed the research capacity and culture survey to evaluate team success, barriers and motivators to undertaking research, and an audit of research activity from January 2013 to August 2014 was undertaken within each team. Kendell's correlation coefficients were used to determine the association between research activity (i.e., number of journal publications, ethically approved projects and funding received) and the self-reported measures. Seven out of eight teams rated their teams as having average success in research and demonstrated some form of research activity including at least two ethically approved projects. Research activity varied between teams, with funding received ranging from $0 to over $100,000, and half the teams not producing any journal publications. Team motivators demonstrated a stronger association with research activity compared to barriers, with the motivator "enhancing team credibility" being significantly associated with funding received. No significant association between self-reported research

Resuscitative Hyperkalemia in Noncrush Trauma: A Prospective, Observational Study

DTIC Science & Technology

2006-12-01

Resuscitative Hyperkalemia in Noncrush Trauma: A Prospective, Observational Study Robert M. Perkins,*† Matthew C. Aboudara,* Kevin C. Abbott,*† and...Surgical Research, San Antonio, Texas The trauma patient is exposed to physiologic processes and life-saving interventions that predispose to hyperkalemia ...in the care of the massively traumatized patient may or may not increase the risk for hyperkalemia . This prospective, observational study was

Tire pressure special study : vehicle observation data

DOT National Transportation Integrated Search

2001-08-01

Twenty seven percent of passenger cars with : regular passenger car tires have at least one : tire that is underinflated by 8 psi or more. : Tire Pressure Special Study: Vehicle : Observation Data is the third in a series of : research notes co...

Is safety of childhood growth hormone therapy related to dose? Data from a large observational study.

PubMed

Sävendahl, Lars; Pournara, Effie; Pedersen, Birgitte Tønnes; Blankenstein, Oliver

2016-05-01

Concerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice. NordiNet(®) International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin(®) (somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark). Long-term safety data (1998-2013) were collected on 13 834 growth hormone treated pediatric patients with short stature. Incidence rates (IRs) of adverse events (AEs) defined as adverse drug reactions (ADRs), serious ADRs (SADRs), and serious AEs (SAEs) were calculated by mortality risk group (low/intermediate/high). The effect of growth hormone dose on IRs and the occurrence of cerebrovascular AEs were investigated by the risk group. We found that 61.0% of patients were classified as low-risk, 33.9% intermediate-risk, and 5.1% high-risk. Three hundred and two AEs were reported in 261 (1.9%) patients during a mean (s.d.) treatment duration of 3.9 (2.8) years. IRs were significantly higher in the high- vs the low-risk group (high risk vs low risk-ADR: 9.11 vs 3.14; SAE: 13.66 vs 1.85; SADR: 4.97 vs 0.73 events/1000 patient-years of exposure; P < 0.0001 for all). Except for SAEs in the intermediate-risk group (P = 0.0486) in which an inverse relationship was observed, no association between IRs and growth hormone dose was found. No cerebrovascular events were reported. We conclude that safety data from NordiNet(®) IOS do not reveal any new safety signals and confirm a favorable overall safety profile in accordance with other pediatric observational studies. No association between growth hormone dose and the incidence of AEs during growth hormone treatment in childhood was found. © 2016 European Society of Endocrinology.

Weaknesses in the reporting of cross-sectional studies according to the STROBE statement

PubMed Central

Malaga, German; Miranda, Jaime

2015-01-01

Introduction: The inadequate reporting of cross-sectional studies, as in the case of the prevalence of metabolic syndrome, could cause problems in the synthesis of new evidence and lead to errors in the formulation of public policies. Objective: To evaluate the reporting quality of the articles regarding metabolic syndrome prevalence in Peruvian adults using the STROBE recommendations. Methods: We conducted a thorough literature search with the terms "Metabolic Syndrome", "Sindrome Metabolico" and "Peru" in MEDLINE/PubMed, LILACS, SciELO, LIPECS and BVS-Peru until December 2014. We selected those who were population-based observational studies with randomized sampling that reported prevalence of metabolic syndrome in adults aged 18 or more of both sexes. Information was analysed through the STROBE score per item and recommendation. Results: Seventeen articles were included in this study. All articles met the recommendations related to the report of the study's rationale, design, and provision of summary measures. The recommendations with the lowest scores were those related to the sensitivity analysis (8%, n= 1/17), participant flowchart (18%, n= 3/17), missing data analysis (24%, n= 4/17), and number of participants in each study phase (24%, n= 4/17). Conclusion: Cross-sectional studies regarding the prevalence of metabolic syndrome in peruvian adults have an inadequate reporting on the methods and results sections. We identified a clear need to improve the quality of such studies. PMID:26848197

Separate Medication Preparation Rooms Reduce Interruptions and Medication Errors in the Hospital Setting: A Prospective Observational Study.

PubMed

Huckels-Baumgart, Saskia; Baumgart, André; Buschmann, Ute; Schüpfer, Guido; Manser, Tanja

2016-12-21

Interruptions and errors during the medication process are common, but published literature shows no evidence supporting whether separate medication rooms are an effective single intervention in reducing interruptions and errors during medication preparation in hospitals. We tested the hypothesis that the rate of interruptions and reported medication errors would decrease as a result of the introduction of separate medication rooms. Our aim was to evaluate the effect of separate medication rooms on interruptions during medication preparation and on self-reported medication error rates. We performed a preintervention and postintervention study using direct structured observation of nurses during medication preparation and daily structured medication error self-reporting of nurses by questionnaires in 2 wards at a major teaching hospital in Switzerland. A volunteer sample of 42 nurses was observed preparing 1498 medications for 366 patients over 17 hours preintervention and postintervention on both wards. During 122 days, nurses completed 694 reporting sheets containing 208 medication errors. After the introduction of the separate medication room, the mean interruption rate decreased significantly from 51.8 to 30 interruptions per hour (P < 0.01), and the interruption-free preparation time increased significantly from 1.4 to 2.5 minutes (P < 0.05). Overall, the mean medication error rate per day was also significantly reduced after implementation of the separate medication room from 1.3 to 0.9 errors per day (P < 0.05). The present study showed the positive effect of a hospital-based intervention; after the introduction of the separate medication room, the interruption and medication error rates decreased significantly.

Dietary Micronutrient Intake and Micronutrient Status in Patients With Chronic Stable Heart Failure: An Observational Study.

PubMed

McKeag, Nicholas A; McKinley, Michelle C; Harbinson, Mark T; McGinty, Ann; Neville, Charlotte E; Woodside, Jayne V; McKeown, Pascal P

Observational studies suggest that patients with heart failure have a tendency to a reduced status of a number of micronutrients and that this may be associated with an adverse prognosis. A small number of studies also suggest that patients with heart failure may have reduced dietary intake of micronutrients, a possible mechanism for reduced status. The aims of this study were to assess dietary micronutrient intake and micronutrient status in a group of patients with heart failure. Dietary intake was assessed in 79 outpatients with chronic stable heart failure with a reduced ejection fraction using a validated food frequency questionnaire. Blood concentrations of a number of micronutrients, including vitamin D, were measured in fasting blood samples, drawn at the time of food frequency questionnaire completion. More than 20% of patients reported intakes less than the reference nutrient intake or recommended intake for riboflavin, vitamin D, vitamin A, calcium, magnesium, potassium, zinc, copper, selenium, and iodine. More than 5% of patients reported intakes less than the lower reference nutrient intake or minimum recommended intake for riboflavin, vitamin D, vitamin A, calcium, magnesium, potassium, zinc, selenium, and iodine. Vitamin D deficiency (plasma total 25-hydroxy-vitamin D concentration <50 nmol/L) was observed in 75.6% of patients. Vitamin D deficiency was common in this group of patients with heart failure. Based on self-reported dietary intake, a substantial number of individuals may not have been consuming enough vitamin D and a modest number of individuals may not have been consuming enough riboflavin, vitamin A, calcium, magnesium, potassium, zinc, copper, selenium, or iodine to meet their dietary needs.

Examining the accuracy of students' self-reported academic grades from a correlational and a discrepancy perspective: Evidence from a longitudinal study.

PubMed

Sticca, Fabio; Goetz, Thomas; Bieg, Madeleine; Hall, Nathan C; Eberle, Franz; Haag, Ludwig

2017-01-01

The present longitudinal study examined the reliability of self-reported academic grades across three phases in four subject domains for a sample of 916 high-school students. Self-reported grades were found to be highly positively correlated with actual grades in all academic subjects and across grades 9 to 11 underscoring the reliability of self-reported grades as an achievement indicator. Reliability of self-reported grades was found to differ across subject areas (e.g., mathematics self-reports more reliable than language studies), with a slight yet consistent tendency to over-report achievement levels also observed across grade levels and academic subjects. Overall, the absolute value of over- and underreporting was low and these patterns were not found to differ between mathematics and verbal subjects. In sum, study findings demonstrate the consistent predictive utility of students' self-reported achievement across grade levels and subject areas with the observed tendency to over-report academic grades and slight differences between domains nonetheless warranting consideration in future education research.

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

PubMed

Hohl, Corinne M; Small, Serena S; Peddie, David; Badke, Katherin; Bailey, Chantelle; Balka, Ellen

2018-02-27

Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. ©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR

Active-comparator design and new-user design in observational studies

PubMed Central

Yoshida, Kazuki; Solomon, Daniel H.; Kim, Seoyoung C.

2015-01-01

SUMMARY Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of rheumatoid arthritis treatments. However, unlike randomized controlled trials (RCTs), observational studies of drug effects face methodological challenges including confounding by indication. Two design principles - active comparator design and new user design can help mitigate such challenges in observational studies. To improve validity of study findings, observational studies should be designed in such a way that makes them more closely approximate RCTs. The active comparator design compares the drug of interest to another commonly used agent for the same indication, rather than a ‘non-user’ group. This principle helps select treatment groups similar in treatment indications (both measured and unmeasured characteristics). The new user design includes a cohort of patients from the time of treatment initiation, so that it can assess patients’ pretreatment characteristics and capture all events occurring anytime during follow-up. PMID:25800216

Miltefosine treatment of Leishmania major infection: an observational study involving Dutch military personnel returning from northern Afghanistan.

PubMed

van Thiel, P P A M; Leenstra, T; Kager, P A; de Vries, H J; van Vugt, M; van der Meide, W F; Bart, A; Zeegelaar, J E; van der Sluis, A; Schallig, H D F H; van Gool, T; Faber, W R; de Vries, P J

2010-01-01

In a retrospective, observational study involving 34 patients with Leishmania major infection, 31 of whom had experienced unsuccessful treatment with intralesional antimony (ilSb(v)), miltefosine proved effective. Thirty patients experienced cure after receipt of miltefosine, 3 after receipt of additional ilSb(v), and 1 after 28 daily intravenous injections of antimony. Temporary diminution of ejaculate volume was reported by 21 patients.

The effects of single-session music therapy interventions on the observed and self-reported levels of pain control, physical comfort, and relaxation of hospice patients.

PubMed

Krout, R E

2001-01-01

This article describes the process and results of a three-month music therapy clinical effectiveness study conducted with terminally ill patients. The purpose of this study was to quantify and evaluate the effectiveness of single-session music therapy interventions with hospice patients in three patient problem areas: pain control; physical comfort; and relaxation. Data from a total of 90 sessions conducted with a total of 80 subjects served by Hospice of Palm Beach County, Florida, were included in the study. Music therapy services were provided by five board-certified music therapists and one music therapist eligible for board certification. The subjects in this study were receiving regularly scheduled music therapy services from the hospice organization. The study used both behavioral observation and subject's self-reporting as methods of data reporting and recording. Subjects were observed for, or self-reported, their levels of pain control, physical comfort, and relaxation, both before and after each music therapy session. The subjects were served in the environments where music therapy services would normally be delivered (i.e., home, hospital, nursing home, or inpatient acute-care unit of the hospice organization). Music therapy services included live active and passive music-based experiences. These were designed to build and to establish rapport with patient or family, to facilitate family interaction and patient control, to provide support and comfort, to facilitate relaxation, to enable reminiscence and life review, to provide a frame-work for spiritual exploration and validation, and to encourage the identification and expression of feelings of anticipatory mourning and grief. A total of six hypotheses stated that there would be significant pre- to postsession differences in each of the three variables: pain control, physical comfort, and relaxation, as measured during two different session and data collection scenarios. These scenarios included the

Observing the Communication Behavior of Deaf-Blind Children

ERIC Educational Resources Information Center

Tweedie, David

1974-01-01

Reviewed are observational techniques for rating the communication of deaf-blind multihandicapped children, and reported is an initial study of the diagnostic observational competency of 75 speech pathologists at 5 levels of training and experience. (LC)

Globally Gridded Satellite observations for climate studies

USGS Publications Warehouse

Knapp, K.R.; Ansari, S.; Bain, C.L.; Bourassa, M.A.; Dickinson, M.J.; Funk, Chris; Helms, C.N.; Hennon, C.C.; Holmes, C.D.; Huffman, G.J.; Kossin, J.P.; Lee, H.-T.; Loew, A.; Magnusdottir, G.

2011-01-01

Geostationary satellites have provided routine, high temporal resolution Earth observations since the 1970s. Despite the long period of record, use of these data in climate studies has been limited for numerous reasons, among them that no central archive of geostationary data for all international satellites exists, full temporal and spatial resolution data are voluminous, and diverse calibration and navigation formats encumber the uniform processing needed for multisatellite climate studies. The International Satellite Cloud Climatology Project (ISCCP) set the stage for overcoming these issues by archiving a subset of the full-resolution geostationary data at ~10-km resolution at 3-hourly intervals since 1983. Recent efforts at NOAA's National Climatic Data Center to provide convenient access to these data include remapping the data to a standard map projection, recalibrating the data to optimize temporal homogeneity, extending the record of observations back to 1980, and reformatting the data for broad public distribution. The Gridded Satellite (GridSat) dataset includes observations from the visible, infrared window, and infrared water vapor channels. Data are stored in Network Common Data Format (netCDF) using standards that permit a wide variety of tools and libraries to process the data quickly and easily. A novel data layering approach, together with appropriate satellite and file metadata, allows users to access GridSat data at varying levels of complexity based on their needs. The result is a climate data record already in use by the meteorological community. Examples include reanalysis of tropical cyclones, studies of global precipitation, and detection and tracking of the intertropical convergence zone.

Comparing EQ-5D valuation studies: a systematic review and methodological reporting checklist.

PubMed

Xie, Feng; Gaebel, Kathryn; Perampaladas, Kuhan; Doble, Brett; Pullenayegum, Eleanor

2014-01-01

There has been a growing interest around the world in developing country-specific scoring algorithms for the EQ-5D. This study systematically reviews all existing EQ-5D valuation studies to highlight their strengths and limitations, explores heterogeneity in observed utilities using meta-regression, and proposes a methodological checklist for reporting EQ-5D valuation studies. . We searched Medline, EMBASE, the National Health Service Economic Evaluation Database (NHS EED) via Wiley's Cochrane Library, and Wiley's Health Economic Evaluation Database from inception through November 2012, as well as bibliographies of key papers and the EuroQol Plenary Meeting Proceedings from 1991 to 2012 for English-language reports of EQ-5D valuation studies. Two reviewers independently screened the titles and abstracts for relevance. Three reviewers performed data extraction and compared the characteristics and scoring algorithms developed in the included valuation studies. . Of the 31 studies included in the review, 19 used the time trade-off (TTO) technique, 10 used the visual analogue scale (VAS) technique, and 2 used both TTO and VAS. Most studies included respondents from the general population selected by random or quota sampling and used face-to-face interviews or postal surveys. Studies valued between 7 and 198 total states, with 1-23 states valued per respondent. Different model specifications have been proposed for scoring. Some sample or demographic factors, including gender, education, percentage urban population, and national health care expenditure, were associated with differences in observed utilities for moderate or severe health states. . EQ-5D valuation studies conducted to date have varied widely in their design and in the resulting scoring algorithms. Therefore, we propose the Checklist for Reporting Valuation Studies of the EQ-5D (CREATE) for those conducting valuation studies.

Lacosamide in patients with gliomas and uncontrolled seizures: results from an observational study.

PubMed

Rudà, Roberta; Pellerino, Alessia; Franchino, Federica; Bertolotti, Cinzia; Bruno, Francesco; Mo, Francesca; Migliore, Enrica; Ciccone, Gianni; Soffietti, Riccardo

2018-01-01

To report the efficacy and tolerability of lacosamide as an add-on treatment in patients with gliomas and uncontrolled seizures despite conventional antiepileptic drugs (AEDs). We conducted an observational study on 71 patients to describe patterns of response to lacosamide and the association between clinico-pathological factors and seizure control. We observed at 3, 6 and 9 months a seizure reduction ≥ 50% in 74.6, 76 and 86.2% of patients and a seizure freedom in 42.2, 43 and 50%, respectively. The median number of seizures in the 3 months before treatment was 13, and decreased to 3 between baseline and 6 months, and to 0.5 between 6 and 9 months. The best seizure response was observed at 3 months (62%). Sixty per cent of patients displayed the maximum seizure control with doses of lacosamide of 100-250 mg/day, while 21% needed doses up to 400 mg/day. Seizure reduction ≥ 50% and seizure freedom were higher in patients who received lacosamide as first add-on compared to those who received a later adjunctive therapy. A reduction ≥ 50% of seizures was observed in a proportion of patients with progressive disease on MRI. Age > 45 years (OR 0.11, 95% CI 0.02-0.63, p = 0.013) was a significant predictor of seizure freedom at 9 months on multivariate analysis. The study suggests that lacosamide, when added to any baseline AEDs, is effective in obtaining a high seizure reduction and seizure freedom regardless of the tumor activity and response to antineoplastic therapies.