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Sample records for trial observational study

  1. Challenges in translating end points from trials to observational cohort studies in oncology

    Directory of Open Access Journals (Sweden)

    Ording AG

    2016-06-01

    Full Text Available Anne Gulbech Ording,1 Deirdre Cronin-Fenton,1 Vera Ehrenstein,1 Timothy L Lash,1,2 John Acquavella,1 Mikael Rørth,1 Henrik Toft Sørensen1 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Abstract: 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. Keywords: endpoint determination, medical oncology

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

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    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

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

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    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.

  4. Communication about Children's Clinical Trials as Observed and Experienced: Qualitative Study of Parents and Practitioners

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    Shilling, Valerie; Williamson, Paula R.; Hickey, Helen; Sowden, Emma; Beresford, Michael W.; Smyth, Rosalind L.; Young, Bridget

    2011-01-01

    Background Recruiting children to clinical trials is perceived to be challenging. To identify ways to optimise recruitment and its conduct, we compared how parents and practitioners described their experiences of recruitment to clinical trials. Methods and Findings This qualitative study ran alongside four children's clinical trials in 11 UK research sites. It compared analyses of semi-structured interviews with analyses of audio-recordings of practitioner-family dialogue during trial recruitment discussions. Parents from 59 families were interviewed; 41 had participated in audio-recorded recruitment discussions. 31 practitioners were interviewed. Parents said little in the recruitment discussions contributing a median 16% of the total dialogue and asking a median of one question. Despite this, parents reported a positive experience of the trial approach describing a sense of comfort and safety. Even if they declined or if the discussion took place at a difficult time, parents understood the need to approach them and spoke of the value of research. Some parents viewed participation as an ‘exciting’ opportunity. By contrast, practitioners often worried that approaching families about research burdened families. Some practitioners implied that recruiting to clinical trials was something which they found aversive. Many were also concerned about the amount of information they had to provide and believed this overwhelmed families. Whilst some practitioners thought the trial information leaflets were of little use to families, parents reported that they used and valued the leaflets. However, both parties agreed that the leaflets were too long and wanted them to be more reader-friendly. Conclusions Parents were more positive about being approached to enter their child into a clinical trial than practitioners anticipated. The concerns of some practitioners, that parents would be overburdened, were unfounded. Educating practitioners about how families perceive clinical

  5. Pediatric anesthesia after the anaesthesia practice in children observational trial study: who should do it?

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    Habre, Walid

    2018-02-12

    This review highlights the requirements for harmonization of training, certification and continuous professional development and discusses the implications for anesthesia management of children in Europe. A large prospective cohort study, Anaesthesia PRactice In Children Observational Trial (APRICOT), revealed a high incidence of perioperative severe critical events and a large variability of anesthesia practice across 33 European countries. Relevantly, quality improvement programs have been implemented in North America, which precisely define the requirements to manage anesthesia care for children. These programs, with the introduction of an incident-reporting system at local and national levels, could contribute to the improvement of anesthesia care for children in Europe. The main factors that likely contributed to the APRICOT study results are discussed with the goal of defining clear requirement guidelines for anesthetizing children. Emphasis is placed on the importance of an incident-reporting system that can be used for both competency-based curriculum for postgraduate training as well as for continuous professional development. Variability in training as well as in available resources, equipment and facilities limit the generalization of some of the APRICOT results. Finally, the impact on case outcome of the total number of pediatric cases attended by the anesthesiologist should be taken into consideration along with the level of expertise of the anesthesiologist for complex pediatric anesthesia cases.

  6. Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity.

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    James, Karen; Quirk, Alan; Patterson, Sue; Brennan, Geoff; Stewart, Duncan

    2017-11-17

    Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used. This study aimed to use these methods to explore the quality of implementation of a complex intervention (Safewards) on mental health wards during a cluster randomised controlled trial. Specific aims were firstly to describe the different ways in which the intervention was implemented, and secondly to explore the contextual factors moderating the quality of intervention delivery, in order to inform 'real world' implementation of the intervention. Safewards was implemented on 16 mental health wards in England. We used Research Assistants (RAs) trained in participant observation to record qualitative observational data on the quality of intervention delivery (n = 565 observations). At the end of the trial, two focus groups were conducted with RAs, which were used to develop the coding framework. Data were analysed using thematic analysis. There was substantial variation in intervention delivery between wards. We observed modifications to the intervention which were both fidelity consistent and inconsistent, and could enhance or dilute the intervention effects. We used these data to develop a typology which describes the different ways in which the intervention was delivered. This typology could be used as a tool to collect qualitative observational data about fidelity during trials. Moderators of Safewards implementation included systemic, interpersonal, and individual factors and patient responses to the intervention. Our study

  7. Outcome reporting across randomised trials and observational studies evaluating treatments for Twin-Twin Transfusion Syndrome: a systematic review.

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    Perry, Helen; Duffy, James M N; Umadia, Ogochukwu; Khalil, Asma

    2018-04-01

    Twin-Twin Transfusion syndrome is associated with significant mortality and morbidity. Potential treatments require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomised controlled trials assessing treatments for twin-twin transfusion syndrome (TTTS). Cochrane Central Register of Controlled Trials, EMBASE and Medline were searched from inception to August 2016. Observational studies and randomised controlled trials reporting outcomes following a treatment for TTTS in monochorionic-diamniotic twin pregnancies and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancies were included. We systematically extracted and categorised outcome reporting. Six randomised trials and 94 observational studies, reporting data from 20,071 maternal participants and 3,199 children, were included. Six different treatments were evaluated. Included studies reported sixty-two different outcomes, including 10 fetal, 28 neonatal, 6 early childhood and 18 maternal outcomes. The outcomes were inconsistently reported across trials. For example, when considering offspring mortality, 31 studies (31%) reported live birth, 31 studies (31%) reported intrauterine death, 49 studies (49%) reported neonatal mortality, and 17 studies (17%) reported perinatal mortality. Four studies (4%) reported respiratory distress syndrome. Only 19 (19%) of studies were designed for long-term follow-up and 11 of these studies (11%) reported cerebral palsy. Most studies evaluating treatments for TTTS, have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes. Most studies are not designed for long-term follow-up. The development of a core outcome set could help standardised outcome collection and reporting in Twin-Twin Transfusion syndrome studies. This article is protected by copyright. All rights reserved.

  8. Presentation and analysis of radiographic data in clinical trials and observational studies

    NARCIS (Netherlands)

    Landewé, R.; van der Heijde, D.

    2005-01-01

    Despite the advent of sophisticated imaging systems, plain radiography continues to be a valuable outcome variable in clinical trials of inflammatory disorders for a number of reasons. This paper discusses the pros and cons of the different ways in which radiographic data in trials is presented; the

  9. Using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement to assess reporting of observational trials in hand surgery.

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    Sorensen, Amelia A; Wojahn, Robert D; Manske, Mary Claire; Calfee, Ryan P

    2013-08-01

    To use the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement checklist to critically evaluate the change in quality of observational trial reporting in the Journal of Hand Surgery American between 2005 and 2011. A cross-sectional analysis of observational studies published in the Journal of Hand Surgery American was designed to sample 2 6-month periods of publication (March 2005 to August 2005 and June 2011 to November 2011). Fifty-one items were extracted from the STROBE statement for evaluation. Overall STROBE compliance rates for articles and specific checklist items were determined. Final compliance percentages from each period were compared by Student t-testing. Changes in item compliance over time were quantified. Overall compliance with the STROBE statement was 38% (range, 10%-54%) in 2005 and 58% (range, 39%-85%) for 2011 manuscripts representing a significant improvement. Seventy-five percent or greater of articles (2005/2011) provided the explicit reporting of background (100%/97%), follow-up time (85%/94%), overall interpretation of data (100%/94%), and results of similar studies (95%/89%). Twenty-five percent or less of articles provided the study design in the abstract (10%/20%), a clear description of the study's setting (10%/23%), the handling of missing data (0%/6%), the potential directions of bias (5%/11%), and the use of a power analysis (0%/17%). Eighty-six percent (44/51) of items were more frequently satisfied in 2011 articles than in 2005 publications. Absolute increases in compliance rates of 40% or greater were noted in 10 items (20%) with no worsening in compliance for an individual item over 6%. The overall quality of the reporting of observational trials in the Journal of Hand Surgery American improved from 2005 to 2011. Current observational trials in hand surgery could still benefit from increased reporting of methodological details including the use of power analyses, the handling of missing data

  10. Statin Therapy and Outcome After Ischemic Stroke: Systematic Review and Meta-Analysis of Observational Studies and Randomized Trials.

    LENUS (Irish Health Repository)

    2013-01-03

    Background-Although experimental data suggest that statin therapy may improve neurological outcome after acute cerebral ischemia, the results from clinical studies are conflicting. We performed a systematic review and meta-analysis investigating the relationship between statin therapy and outcome after ischemic stroke. METHODS: The primary analysis investigated statin therapy at stroke onset (prestroke statin use) and good functional outcome (modified Rankin score 0 to 2) and death. Secondary analyses included the following: (1) acute poststroke statin therapy (≤72 hours after stroke), and (2) thrombolysis-treated patients. RESULTS: The primary analysis included 113 148 subjects (27 studies). Among observational studies, statin treatment at stroke onset was associated with good functional outcome at 90 days (pooled odds ratio [OR], 1.41; 95% confidence interval [CI], 1.29-1.56; P<0.001), but not 1 year (OR, 1.12; 95% CI, 0.9-1.4; P=0.31), and with reduced fatality at 90 days (pooled OR, 0.71; 95% CI, 0.62-0.82; P<0.001) and 1 year (OR, 0.80; 95% CI, 0.67-0.95; P=0.01). In the single randomized controlled trial reporting 90-day functional outcome, statin treatment was associated with good outcome (OR, 1.5; 95% CI, 1.0-2.24; P=0.05). No reduction in fatality was observed on meta-analysis of data from 3 randomized controlled trials (P=0.9). In studies of thrombolysis-treated patients, an association between statins and increased fatality at 90 days was observed (pooled OR, 1.25; 95% CI, 1.02-1.52; P=0.03, 3 studies, 4339 patients). However, this association was no longer present after adjusting for age and stroke severity in the largest study (adjusted OR, 1.14; 95% CI, 0.90-1.44; 4012 patients). CONCLUSIONS: In the largest meta-analysis to date, statin therapy at stroke onset was associated with improved outcome, a finding not observed in studies restricted to thrombolysis-treated patients. Randomized trials of statin therapy in acute ischemic stroke are needed.

  11. Protocol-Based Resuscitation for Septic Shock: A Meta-Analysis of Randomized Trials and Observational Studies.

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    Lee, Woo Kyung; Kim, Ha Yeon; Lee, Jinae; Koh, Shin Ok; Kim, Jeong Min; Na, Sungwon

    2016-09-01

    Owing to the recommendations of the Surviving Sepsis Campaign guidelines, protocol-based resuscitation or goal-directed therapy (GDT) is broadly advocated for the treatment of septic shock. However, the most recently published trials showed no survival benefit from protocol-based resuscitation in septic shock patients. Hence, we aimed to assess the effect of GDT on clinical outcomes in such patients. We performed a systematic review that included a meta-analysis. We used electronic search engines including PubMed, Embase, and the Cochrane database to find studies comparing protocol-based GDT to common or standard care in patients with septic shock and severe sepsis. A total of 13269 septic shock patients in 24 studies were included [12 randomized controlled trials (RCTs) and 12 observational studies]. The overall mortality odds ratio (OR) [95% confidence interval (CI)] for GDT versus conventional care was 0.746 (0.631-0.883). In RCTs only, the mortality OR (95% CI) for GDT versus conventional care in the meta-analysis was 0.93 (0.75-1.16). The beneficial effect of GDT decreased as more recent studies were added in an alternative, cumulative meta-analysis. No significant publication bias was found. The result of this meta-analysis suggests that GDT reduces mortality in patients with severe sepsis or septic shock. However, our cumulative meta-analysis revealed that the reduction of mortality risk was diminished as more recent studies were added.

  12. Next-generation sequencing diagnostics of bacteremia in sepsis (Next GeneSiS-Trial): Study protocol of a prospective, observational, noninterventional, multicenter, clinical trial.

    Science.gov (United States)

    Brenner, Thorsten; Decker, Sebastian O; Grumaz, Silke; Stevens, Philip; Bruckner, Thomas; Schmoch, Thomas; Pletz, Mathias W; Bracht, Hendrik; Hofer, Stefan; Marx, Gernot; Weigand, Markus A; Sohn, Kai

    2018-02-01

    Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime. In this context, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care, although they are associated with relevant limitations. Accordingly, culture-independent molecular diagnostic procedures might be of help for the identification of the causative pathogen in infected patients. The concept of an unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) has recently been identified to be a promising diagnostic platform for critically ill patients suffering from bloodstream infections. Although this new approach might be more sensitive and specific than culture-based state-of-the-art technologies, additional clinical trials are needed to exactly define the performance as well as clinical value of a NGS-based approach. Next GeneSiS is a prospective, observational, noninterventional, multicenter study to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in patients with suspected or proven sepsis [according to recent sepsis definitions (sepsis-3)] by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard (culture-based) microbiological diagnostics. The clinical value of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients' management based on NGS results. Further subgroup analyses will focus on the clinical value especially for patients suffering from a failure of empiric treatment within the first 3 days after onset [as assessed by death of the patient or lack of improvement of the patient's clinical condition (in terms of an inadequate decrease of SOFA-score) or

  13. The suitability of caffeinated drinks for children: a systematic review of randomised controlled trials, observational studies and expert panel guidelines.

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    Ruxton, C H S

    2014-08-01

    The increased availability of caffeinated drinks raises questions about the level of caffeine that is appropriate for children, as well as the benefits and risks associated with their consumption. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, this systematic review evaluates evidence from randomised controlled trials investigating the effects of caffeine on cognition, behaviour, mood and exercise performance in children. Observational studies and expert panel guidelines are also discussed. One hundred and nine studies were found, with 11 randomised controlled trials and 13 observational studies meeting the criteria. High caffeine intakes (e.g. >5 mg kg(-1) body weight day(-1)) were associated with an increased risk of anxiety and withdrawal symptoms. However, smaller amounts were not linked with such effects and may benefit cognitive function and sports performance based on adult studies. The evidence suggests that children and adolescents should limit daily caffeine consumption to 2.5 mg kg(-1) body weight day(-1), equating to one or two cups of tea or one small cup of coffee. Lower contributors of caffeine, such as tea, may be more appropriate for children because they contribute to daily fluid intakes and provide flavonoids. By contrast, caffeinated soft drinks may be less suitable options for children as a result of their acidity, higher caffeine content, presence of added sugar (in some cases) and absence of bioactive compounds. More studies are needed to determine the intakes that represent a risk and whether there may be benefits for alertness and sports performance with moderate intakes of caffeine. © 2013 The British Dietetic Association Ltd.

  14. Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Miravitlles M

    2015-03-01

    Full Text Available Marc Miravitlles,1 David Price,2 Klaus F Rabe,3,7 Hendrik Schmidt,4 Norbert Metzdorf,5 Bartolome Celli6 1Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 2Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Department of Medicine, Christian-Albrechts-Universität zu Kiel (CAU, Großhansdorf, Germany; 4Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 6Pulmonary Division, Brigham and Women’s Hospital, Boston, MA, USA; 7LungenClinic Grosshansdorf, Großhansdorf, Germany Background: There is an ongoing debate on whether patients with chronic obstructive pulmonary disease (COPD seen in real-life clinical settings are represented in randomized controlled trials (RCTs of COPD. It is thought that the stringent inclusion and exclusion criteria of RCTs may prevent the participation of patients with specific characteristics or risk factors.Methods: We surveyed a database of patients recruited into 35 placebo-controlled tiotropium RCTs and also conducted a systematic literature review of large-scale observational studies conducted in patients with a documented diagnosis of COPD between 1990 and 2013. Patient demographics and comorbidities with a high prevalence in patients with COPD were compared between the two patient populations at baseline. Using the Medical Dictionary for Regulatory Activities (MedDRA; v 14.0, patient comorbidities in the pooled tiotropium RCTs were classified according to system organ class, pharmacovigilance (PV endpoints, and Standardised MedDRA Queries to enable comparison with the observational studies.Results: We identified 24,555 patients in the pooled tiotropium RCTs and 61,361 patients among the 13 observational studies that met our

  15. Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability study.

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    Gerke, Oke; Vilstrup, Mie H; Halekoh, Ulrich; Hildebrandt, Malene Grubbe; Høilund-Carlsen, Poul Flemming

    2017-09-26

    Group-sequential testing is widely used in pivotal therapeutic, but rarely in diagnostic research, although it may save studies, time, and costs. The purpose of this paper was to demonstrate a group-sequential analysis strategy in an intra-observer study on quantitative FDG-PET/CT measurements, illuminating the possibility of early trial termination which implicates significant potential time and resource savings. Primary lesion maximum standardised uptake value (SUVmax) was determined twice from preoperative FDG-PET/CTs in 45 ovarian cancer patients. Differences in SUVmax were assumed to be normally distributed, and sequential one-sided hypothesis tests on the population standard deviation of the differences against a hypothesised value of 1.5 were performed, employing an alpha spending function. The fixed-sample analysis (N = 45) was compared with the group-sequential analysis strategies comprising one (at N = 23), two (at N = 15, 30), or three interim analyses (at N = 11, 23, 34), respectively, which were defined post hoc. When performing interim analyses with one third and two thirds of patients, sufficient agreement could be concluded after the first interim analysis and the final analysis. Other partitions did not suggest early stopping after adjustment for multiple testing due to one influential outlier and our small sample size. Group-sequential testing may enable early stopping of a trial, allowing for potential time and resource savings. The testing strategy must, though, be defined at the planning stage, and sample sizes must be reasonably large at interim analysis to ensure robustness against single outliers. Group-sequential testing may have a place in accuracy and agreement studies.

  16. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

    Directory of Open Access Journals (Sweden)

    Kardos P

    2016-11-01

    Full Text Available Peter Kardos,1 Sally Worsley,2 Dave Singh,3 Miguel Román-Rodríguez,4 David E Newby,5 Hana Müllerová2 1Group Practice and Respiratory, Allergy and Sleep Unit, Red Cross Maingau Hospital, Frankfurt, Germany; 2GSK, Stockley Park, Middlesex, 3University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK; 4Primary Care Respiratory Research Unit, Instituto de Investigación Sanitaria de Palma IdisPa, Palma de Mallorca, Spain; 5BHF Centre for Cardiovascular Science, University of Edinburgh, The Queen’s Medical Research Institute, Edinburgh, UK Abstract: Long-acting muscarinic antagonist (LAMA or long-acting β2-agonist (LABA bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD. Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs, questions remain regarding their cardiovascular (CV safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and

  17. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries.

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    Hartmann, Markus

    2012-04-29

    Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials. Rates of Clinical Trial Applications (CTA) for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies. Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth). For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P EU-wide trial-phase-specific patterns or trends were observed. The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to the

  18. Peripheral ARtery Atherosclerotic DIsease and SlEep disordered breathing (PARADISE) trial - protocol for an observational cohort study.

    Science.gov (United States)

    Szymański, Filip M; Gałązka, Zbigniew; Płatek, Anna E; Górko, Dariusz; Ostrowski, Tomasz; Adamkiewicz, Karolina; Łęgosz, Paweł; Ryś, Anna; Semczuk-Kaczmarek, Karolina; Celejewski, Krzysztof; Filipiak, Krzysztof J

    2017-01-01

    Peripheral arterial disease (PAD) is in fact a group of disease entities with different symptoms and course but a common underlying cause, i.e. atherosclerosis. Atherosclerosis is known to be aggravated by several cardiovascular risk factors, including obstructive sleep apnoea (OSA). Following paper is a protocol for the Peripheral ARtery Atherosclerotic DIsease and SlEep disordered breathing (PARADISE) trial, which aims to describe the prevalence of OSA in PAD patients scheduled for revascularisation, and to determine the effect of OSA on the procedure outcomes. The PARADISE study is an observational cohort trial. It plans to include 200 consecutive patients hospitalised for revascularisation due to PAD. In every patient an overnight sleep study will be performed to diagnose sleep disorders. Accord¬ing to the results of the test, patients will be divided into two groups: group A - patients with OSA, and group B - patients without OSA (control group). All patients will also be screened for classical and non-classical cardiovascular risk factors. In some of the patients, during surgery, a fragment of atherosclerotic plaque will be collected for further testing. Patients will be followed for one year for adverse events and end-points. Primary end-point of the study will be the failure of revascularisa¬tion defined as recurrence or new onset of the symptoms of ischaemia from the treated region, a need for re-operation or procedure revision, or recurrence of ischaemia signs on the imaging tests. The data obtained will help determine the incidence of OSA in the population of patients with PAD. The au¬thors expect to show that, as with other cardiovascular diseases associated with atherosclerosis, also in patients with PAD the incidence of undiagnosed OSA is high and its presence is associated with elevated cholesterol, inflammatory markers, and higher prevalence of arterial hypertension and poor control of other cardiovascular risk factors. In addition, due to

  19. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries

    Directory of Open Access Journals (Sweden)

    Hartmann Markus

    2012-04-01

    Full Text Available Abstract Background Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials. Methods Rates of Clinical Trial Applications (CTA for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies. Results Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth. For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P Conclusions The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to

  20. Clinical-Genetic Associations in the Prospective Huntington at Risk Observational Study (PHAROS): Implications for Clinical Trials.

    Science.gov (United States)

    Biglan, Kevin Michael; Shoulson, Ira; Kieburtz, Karl; Oakes, David; Kayson, Elise; Shinaman, M Aileen; Zhao, Hongwei; Romer, Megan; Young, Anne; Hersch, Steven; Penney, Jack; Marder, Karen; Paulsen, Jane; Quaid, Kimberly; Siemers, Eric; Tanner, Caroline; Mallonee, William; Suter, Greg; Dubinsky, Richard; Gray, Carolyn; Nance, Martha; Bundlie, Scott; Radtke, Dawn; Kostyk, Sandra; Baic, Corrine; Caress, James; Walker, Francis; Hunt, Victoria; O'Neill, Christine; Chouinard, Sylvain; Factor, Stewart; Greenamyre, Timothy; Wood-Siverio, Cathy; Corey-Bloom, Jody; Song, David; Peavy, Guerry; Moskowitz, Carol; Wesson, Melissa; Samii, Ali; Bird, Thomas; Lipe, Hillary; Blindauer, Karen; Marshall, Frederick; Zimmerman, Carol; Goldstein, Jody; Rosas, Diana; Novak, Peter; Caviness, John; Adler, Charles; Duffy, Amy; Wheelock, Vicki; Tempkin, Teresa; Richman, David; Seeberger, Lauren; Albin, Roger; Chou, Kelvin L; Racette, Brad; Perlmutter, Joel S; Perlman, Susan; Bordelon, Yvette; Martin, Wayne; Wieler, Marguerite; Leavitt, Blair; Raymond, Lynn; Decolongon, Joji; Clarke, Lorne; Jankovic, Joseph; Hunter, Christine; Hauser, Robert A; Sanchez-Ramos, Juan; Furtado, Sarah; Suchowersky, Oksana; Klimek, Mary Lou; Guttman, Mark; Sethna, Rustom; Feigin, Andrew; Cox, Marie; Shannon, Barbara; Percy, Alan; Dure, Leon; Harrison, Madaline; Johnson, William; Higgins, Donald; Molho, Eric; Nickerson, Constance; Evans, Sharon; Hobson, Douglas; Singer, Carlos; Galvez-Jimenez, Nestor; Shannon, Kathleen; Comella, Cynthia; Ross, Christopher; Saint-Hilaire, Marie H; Testa, Claudia; Rosenblatt, Adam; Hogarth, Penelope; Weiner, William; Como, Peter; Kumar, Rajeev; Cotto, Candace; Stout, Julie; Brocht, Alicia; Watts, Arthur; Eberly, Shirley; Weaver, Christine; Foroud, Tatiana; Gusella, James; MacDonald, Marcy; Myers, Richard; Fahn, Stanley; Shults, Clifford

    2016-01-01

    Identifying measures that are associated with the cytosine-adenine-guanine (CAG) expansion in individuals before diagnosis of Huntington disease (HD) has implications for designing clinical trials. To identify the earliest features associated with the motor diagnosis of HD in the Prospective Huntington at Risk Observational Study (PHAROS). A prospective, multicenter, longitudinal cohort study was conducted at 43 US and Canadian Huntington Study Group research sites from July 9, 1999, through December 17, 2009. Participants included 983 unaffected adults at risk for HD who had chosen to remain unaware of their mutation status. Baseline comparability between CAG expansion (≥37 repeats) and nonexpansion (Huntington disease mutation status in individuals with CAG expansion vs without CAG expansion. Unified Huntington's Disease Rating Scale motor (score range, 0-124; higher scores indicate greater impairment), cognitive (symbol digits modality is the total number of correct responses in 90 seconds; lower scores indicate greater impairment), behavioral (score range, 0-176; higher scores indicate greater behavioral symptoms), and functional (Total Functional Capacity score range, 0-13; lower scores indicate reduced functional ability) domains were assessed at baseline and every 9 months up to a maximum of 10 years. Among the 983 research participants at risk for HD in the longitudinal cohort, 345 (35.1%) carried the CAG expansion and 638 (64.9%) did not. The mean (SD) duration of follow-up was 5.8 (3.0) years. At baseline, participants with expansions had more impaired motor (3.0 [4.2] vs 1.9 [2.8]; P < .001), cognitive (P < .05 for all measures except Verbal Fluency, P = .52), and behavioral domain scores (9.4 [11.4] vs 6.5 [8.5]; P < .001) but not significantly different measures of functional capacity (12.9 [0.3] vs 13.0 [0.2]; P = .23). With findings reported as mean slope (95% CI), in the longitudinal analyses, participants with CAG expansions

  1. Report from the OMERACT Hand Osteoarthritis Working Group: Set of Core Domains and Preliminary Set of Instruments for Use in Clinical Trials and Observational Studies

    NARCIS (Netherlands)

    Kloppenburg, Margreet; Bøyesen, Pernille; Visser, A. Willemien; Haugen, Ida K.; Boers, Maarten; Boonen, Annelies; Conaghan, Philip G.; Hawker, Gillian A.; Kvien, Tore K.; Landewé, Robert; Uhlig, Till; Smeets, Wilma; Greibrokk, Elsie; van der Heijde, Désirée M.

    2015-01-01

    During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals were to endorse a core set of contextual factors for these settings, and to define preliminary

  2. People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Khachadourian, Vahe; Truzyan, Nune; Harutyunyan, Arusyak; Thompson, Michael E; Harutyunyan, Tsovinar; Petrosyan, Varduhi

    2015-06-22

    Tuberculosis is a major public health concern resulting in high rates of morbidity and mortality worldwide, particularly in low- and middle-income countries. Tuberculosis requires a long and intensive course of treatment. Thus, various approaches, including patient empowerment, education and counselling sessions, and involvement of family members and community workers, have been suggested for improving treatment adherence and outcome. The current randomized controlled trial aims to evaluate the effectiveness over usual care of an innovative multicomponent people-centered tuberculosis-care strategy in Armenia. Innovative Approach to Tuberculosis care in Armenia is an open-label, stratified cluster randomized controlled trial with two parallel arms. Tuberculosis outpatient centers are the clusters assigned to intervention and control arms. Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members participate in a short educational and counselling session to raise their knowledge, decrease tuberculosis-related stigma, and enhance treatment adherence. Patients receive the required medications for one week during the weekly visits to the tuberculosis outpatient centers. Additionally, patients receive daily Short Message Service (SMS) reminders to take their medications and daily phone calls to assure adherence and monitoring of treatment potential side effects. Control-arm patients follow the World Health Organization--recommended directly observed treatment strategy, including daily visits to tuberculosis outpatient centers for drug-intake. The primary outcome is physician-reported treatment outcome. Patients' knowledge, depression, quality of life, within-family tuberculosis-related stigma, family social support, and self-reported adherence to tuberculosis treatment are secondary outcomes. Improved adherence and tuberculosis treatment outcomes can strengthen tuberculosis control and thereby forestall

  3. Liberal versus restricted fluid resuscitation strategies in trauma patients: a systematic review and meta-analysis of randomized controlled trials and observational studies*.

    Science.gov (United States)

    Wang, Chih-Hung; Hsieh, Wen-Han; Chou, Hao-Chang; Huang, Yu-Sheng; Shen, Jen-Hsiang; Yeo, Yee Hui; Chang, Huai-En; Chen, Shyr-Chyr; Lee, Chien-Chang

    2014-04-01

    Hemorrhage is responsible for most deaths that occur during the first few hours after trauma. Animal models of trauma have shown that restricting fluid administration can reduce the risk of death; however, studies in patients are difficult to conduct due to logistical and ethical problems. To maximize the value of the existing evidence, we performed a meta-analysis to compare liberal versus restricted fluid resuscitation strategies in trauma patients. Medline and Embase were systemically searched from inception to February 2013. We selected randomized controlled trials and observational studies that compared different fluid administration strategies in trauma patients. There were no restrictions for language, population, or publication year. Four randomized controlled trials and seven observational studies were identified from 1,106 references. One of the randomized controlled trials suffered from a high protocol violation rate and was excluded from the final analysis. The quantitative synthesis indicated that liberal fluid resuscitation strategies might be associated with higher mortality than restricted fluid strategies, both in randomized controlled trials (risk ratio, 1.25; 95% CI, 1.01-1.55; three trials; I(2), 0) and observational studies (odds ratio, 1.14; 95% CI, 1.01-1.28; seven studies; I(2), 21.4%). When only adjusted odds ratios were pooled for observational studies, odds for mortality with liberal fluid resuscitation strategies increased (odds ratio, 1.19; 95% CI, 1.02-1.38; six studies; I(2), 26.3%). Current evidence indicates that initial liberal fluid resuscitation strategies may be associated with higher mortality in injured patients. However, available studies are subject to a high risk of selection bias and clinical heterogeneity. This result should be interpreted with great caution.

  4. Vitamin D and multiple health outcomes: umbrella review of systematic reviews and meta-analyses of observational studies and randomised trials.

    Science.gov (United States)

    Theodoratou, Evropi; Tzoulaki, Ioanna; Zgaga, Lina; Ioannidis, John P A

    2014-04-01

    To evaluate the breadth, validity, and presence of biases of the associations of vitamin D with diverse outcomes. Umbrella review of the evidence across systematic reviews and meta-analyses of observational studies of plasma 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D concentrations and randomised controlled trials of vitamin D supplementation. Medline, Embase, and screening of citations and references. Three types of studies were eligible for the umbrella review: systematic reviews and meta-analyses that examined observational associations between circulating vitamin D concentrations and any clinical outcome; and meta-analyses of randomised controlled trials assessing supplementation with vitamin D or active compounds (both established and newer compounds of vitamin D). 107 systematic literature reviews and 74 meta-analyses of observational studies of plasma vitamin D concentrations and 87 meta-analyses of randomised controlled trials of vitamin D supplementation were identified. The relation between vitamin D and 137 outcomes has been explored, covering a wide range of skeletal, malignant, cardiovascular, autoimmune, infectious, metabolic, and other diseases. Ten outcomes were examined by both meta-analyses of observational studies and meta-analyses of randomised controlled trials, but the direction of the effect and level of statistical significance was concordant only for birth weight (maternal vitamin D status or supplementation). On the basis of the available evidence, an association between vitamin D concentrations and birth weight, dental caries in children, maternal vitamin D concentrations at term, and parathyroid hormone concentrations in patients with chronic kidney disease requiring dialysis is probable, but further studies and better designed trials are needed to draw firmer conclusions. In contrast to previous reports, evidence does not support the argument that vitamin D only supplementation increases bone mineral density or reduces the risk of

  5. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Science.gov (United States)

    Scott, Amelia; Rucklidge, Julia J; Mulder, Roger T

    2015-01-01

    To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of

  6. Pre-hospital midazolam for benzodiazepine-treated seizures before and after the Rapid Anticonvulsant Medication Prior to Arrival Trial: A national observational cohort study.

    Science.gov (United States)

    Shtull-Leber, Eytan; Silbergleit, Robert; Meurer, William J

    2017-01-01

    Implementation of evidence-based treatment for pre-hospital status epilepticus can improve outcomes. We hypothesized that publication of a pivotal pre-hospital clinical trial (RAMPART), demonstrating superiority of intramuscular midazolam over intravenous lorazepam, altered the national utilization rates of midazolam for pre-hospital benzodiazepine-treated seizures, while upholding its safety and efficacy outside the trial setting. This is a retrospective, observational cohort study of pre-hospital patient encounters throughout the United States in the National Emergency Medicine Services Information System database, from January 2010 through December 2014. We compared the rates and odds of midazolam use as first-line treatment among all adult and pediatric benzodiazepine-treated seizures before and after RAMPART publication (February 2012). Secondary analyses were conducted for rates of airway interventions and rescue therapy, as proxies for safety and efficacy of seizure termination. 156,539 benzodiazepine-treated seizures were identified. Midazolam use increased from 26.1% in January 2010 to 61.7% in December 2014 (difference +35.6%, 95% CI, 32.7%-38.4%). The annual rate of midazolam adoption increased significantly from 5.9% per year to 8.9% per year after the publication of RAMPART (difference +3.0% per year; 95%CI, 1.6%-4.5% per year; adjusted OR 1.24; 95%CI, 1.17-1.32). Overall frequency of rescue therapy and airway interventions changed little after the publication of RAMPART. These data are consistent with effective, ongoing, but incomplete clinical translation of the RAMPART results. The effects of the trial, however, cannot be isolated. The study was limited by broad inclusion of all benzodiazepine-treated seizures as well as a lack of information on route of drug of administration. The safety and effectiveness of midazolam for benzodiazepine-treated seizures in prehospital clinical practice appear consistent with trial data, which should encourage

  7. A systematic literature review on the efficacy–effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs

    Directory of Open Access Journals (Sweden)

    Ankarfeldt MZ

    2017-01-01

    Full Text Available Mikkel Z Ankarfeldt,1,2 Erpur Adalsteinsson,1 Rolf HH Groenwold,2,3 M Sanni Ali,2,3,4 Olaf H Klungel,2,3 On behalf of GetReal Work Package 2 1Novo Nordisk A/S, 2Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, Utrecht, the Netherlands; 4Nuffield Department of Orthopaedics, Rheumatology, Musculoskeletal Sciences, University of Oxford, Oxford, UK Aim: To identify a potential efficacy–effectiveness gap and possible explanations (drivers of effectiveness for differences between results of randomized controlled trials (RCTs and observational studies investigating glucose-lowering drugs. Methods: A systematic literature review was conducted in English language articles published between 1 January, 2000 and 31 January, 2015 describing either RCTs or observational studies comparing glucagon-like peptide-1 analogs (GLP-1 with insulin or comparing dipeptidyl peptidase-4 inhibitors (DPP-4i with sulfonylurea, all with change in glycated hemoglobin (HbA1c as outcome. Medline, Embase, Current Content, and Biosis were searched. Information on effect estimates, baseline characteristics of the study population, publication year, study duration, and number of patients, and for observational studies, characteristics related to confounding adjustment and selection- and information bias were extracted. Results: From 312 hits, 11 RCTs and 7 observational studies comparing GLP-1 with insulin, and from 474 hits, 16 RCTs and 4 observational studies comparing DPP-4i with sulfonylurea were finally included. No differences were observed in baseline characteristics of the study populations (age, sex, body mass index, time since diagnosis of type 2 diabetes mellitus, and HbA1c or effect sizes across study designs. Mean effect sizes ranged from −0.43 to 0.91 and from −0.80 to 1.13 in RCTs and

  8. A Pilot Study Evaluating the Effectiveness of Platelet-Rich Plasma Therapy for Treating Degenerative Tendinopathies: A Randomized Control Trial with Synchronous Observational Cohort.

    Directory of Open Access Journals (Sweden)

    Marni Wesner

    Full Text Available This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP injection for tendinopathy.Randomized control trial (RCT and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group.The Glen Sather Sport Medicine Clinic, Edmonton, Canada.The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies.Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4 ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program.Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection.For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS, disability (>15 point DASH change, and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed.This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology.Controlled-Trials.com ISRCTN68341698.

  9. Primer: challenges in randomized and observational studies

    NARCIS (Netherlands)

    Landewé, Robert; van der Heijde, Désirée

    2007-01-01

    Randomized controlled trials (RCTs) are considered superior to observational studies, and both clinicians and researchers believe that conclusions that stem from observational research are flawed. RCTs, however, have important methodological and interpretational limitations, and particular clinical

  10. Integrating data from randomized controlled trials and observational studies to predict the response to pregabalin in patients with painful diabetic peripheral neuropathy

    Directory of Open Access Journals (Sweden)

    Joe Alexander

    2017-07-01

    Full Text Available Abstract Background More patient-specific medical care is expected as more is learned about variations in patient responses to medical treatments. Analytical tools enable insights by linking treatment responses from different types of studies, such as randomized controlled trials (RCTs and observational studies. Given the importance of evidence from both types of studies, our goal was to integrate these types of data into a single predictive platform to help predict response to pregabalin in individual patients with painful diabetic peripheral neuropathy (pDPN. Methods We utilized three pivotal RCTs of pregabalin (398 North American patients and the largest observational study of pregabalin (3159 German patients. We implemented a hierarchical cluster analysis to identify patient clusters in the Observational Study to which RCT patients could be matched using the coarsened exact matching (CEM technique, thereby creating a matched dataset. We then developed autoregressive moving average models (ARMAXs to estimate weekly pain scores for pregabalin-treated patients in each cluster in the matched dataset using the maximum likelihood method. Finally, we validated ARMAX models using Observational Study patients who had not matched with RCT patients, using t tests between observed and predicted pain scores. Results Cluster analysis yielded six clusters (287–777 patients each with the following clustering variables: gender, age, pDPN duration, body mass index, depression history, pregabalin monotherapy, prior gabapentin use, baseline pain score, and baseline sleep interference. CEM yielded 1528 unique patients in the matched dataset. The reduction in global imbalance scores for the clusters after adding the RCT patients (ranging from 6 to 63% depending on the cluster demonstrated that the process reduced the bias of covariates in five of the six clusters. ARMAX models of pain score performed well (R 2 : 0.85–0.91; root mean square errors: 0.53–0

  11. Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Heeyoung, E-mail: sselmul@hanmail.net [Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul (Korea, Republic of); Song, Seungyeon, E-mail: tmddus0121@hotmail.com [Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul (Korea, Republic of); Oh, Yun-Kyoung, E-mail: rky221@hanmail.net [Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul (Korea, Republic of); Department of Pharmacy, Konkuk University Medical Center, Seoul (Korea, Republic of); Kang, WonKu, E-mail: wkang@cau.ac.kr [College of Pharmacy, Chung-Ang University, Seoul (Korea, Republic of); Kim, Eunyoung, E-mail: eykimjcb777@cau.ac.kr [Evidence-Based Research Laboratory, Division of Health, Social and Clinical Pharmacotherapy, College of Pharmacy, Chung-Ang University, Seoul (Korea, Republic of); College of Pharmacy, Chung-Ang University, Seoul (Korea, Republic of)

    2017-04-15

    Highlights: • Analyzing RCTs and observational studies shows similar CM-ADR developments between genders. • Gender factor is not related to developing CIN and non-renal CM-ADR. • Gender is not a predisposing factor of CM-ADRs under current evidences. - Abstract: Objective: To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination. Material and methods: We systematically searched three electronic databases for eligible studies. In the studies included (n = 18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used. Results: We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR) = 1.07 (95% confidence interval (CI): 0.79–1.46, P = 0.66) for RCTs, and RR = 0.77 (95% CI: 0.58–1.04, P = 0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females. Conclusions: We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed.

  12. Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies

    International Nuclear Information System (INIS)

    Lee, Heeyoung; Song, Seungyeon; Oh, Yun-Kyoung; Kang, WonKu; Kim, Eunyoung

    2017-01-01

    Highlights: • Analyzing RCTs and observational studies shows similar CM-ADR developments between genders. • Gender factor is not related to developing CIN and non-renal CM-ADR. • Gender is not a predisposing factor of CM-ADRs under current evidences. - Abstract: Objective: To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination. Material and methods: We systematically searched three electronic databases for eligible studies. In the studies included (n = 18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used. Results: We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR) = 1.07 (95% confidence interval (CI): 0.79–1.46, P = 0.66) for RCTs, and RR = 0.77 (95% CI: 0.58–1.04, P = 0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females. Conclusions: We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed.

  13. Low-dose acetylsalicylic acid use and the risk of upper gastrointestinal bleeding: A meta-analysis of randomized clinical trials and observational studies

    Science.gov (United States)

    Valkhoff, Vera E; Sturkenboom, Miriam CJM; Hill, Catherine; Veldhuyzen van Zanten, Sander; Kuipers, Ernst J

    2013-01-01

    BACKGROUND: Low-dose acetylsalicylic acid (LDA, 75 mg/day to 325 mg/day) is recommended for primary and secondary prevention of cardiovascular events, but has been linked to an increased risk of upper gastrointestinal bleeding (UGIB). OBJECTIVE: To analyze the magnitude of effect of LDA use on UGIB risk. METHODS: The PubMed and Embase databases were searched for randomized controlled trials (RCTs) reporting UGIB rates in individuals receiving LDA, and observational studies of LDA use in patients with UGIB. Studies were pooled for analysis of UGIB rates. RESULTS: Eighteen studies were included. Seven RCTs reported UGIB rates in individuals randomly assigned to receive LDA (n=22,901) or placebo (n=22,923). Ten case-control studies analyzed LDA use in patients with UGIB (n=10,816) and controls without UGIB (n=30,519); one cohort study reported 207 UGIB cases treated with LDA only. All studies found LDA use to be associated with an increased risk of UGIB. The mean number of extra UGIB cases associated with LDA use in the RCTs was 1.2 per 1000 patients per year (95% CI 0.7 to 1.8). The number needed to harm was 816 (95% CI 560 to 1500) for RCTs and 819 (95% CI 617 to 1119) for observational studies. Meta-analysis of RCT data showed that LDA use was associated with a 50% increase in UGIB risk (OR 1.5 [95% CI 1.2 to 1.8]). UGIB risk was most pronounced in observational studies (OR 3.1 [95% CI 2.5 to 3.7]). CONCLUSIONS: LDA use was associated with an increased risk of UGIB. PMID:23516680

  14. Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies.

    Science.gov (United States)

    Lee, Heeyoung; Song, Seungyeon; Oh, Yun-Kyoung; Kang, WonKu; Kim, Eunyoung

    2017-04-01

    To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination. We systematically searched three electronic databases for eligible studies. In the studies included (n=18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used. We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR)=1.07 (95% confidence interval (CI): 0.79-1.46, P=0.66) for RCTs, and RR=0.77 (95% CI: 0.58-1.04, P=0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females. We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Intravascular ultrasound-guided drug-eluting stent implantation: An updated meta-analysis of randomized control trials and observational studies.

    Science.gov (United States)

    Steinvil, Arie; Zhang, Yao-Jun; Lee, Sang Yeub; Pang, Si; Waksman, Ron; Chen, Shao-Liang; Garcia-Garcia, Hector M

    2016-08-01

    The use of intravascular ultrasound (IVUS) guidance for drug-eluting stent (DES) optimization is limited by the number of adequately powered randomized control trials (RCTs). We performed an updated meta-analysis, including data from recently published RCTs and observational studies, by reviewing the literature in Medline and the Cochrane Library to identify studies that compared clinical outcomes between IVUS-guided and angiography-guided DES implantation from January 1995 to January 2016. This meta-analysis included 25 eligible studies, including 31,283 patients, of whom 3192 patients were enrolled in 7 RCTs. In an analysis of all 25 studies, the summary results for all the events analyzed were significantly in favor of IVUS-guided DES implantation [major adverse cardiac events (MACE, odds ratio [OR] 0.76, 95% confidence intervals [CI]: 0.70-0.82, PDES implantation was found only for MACE (OR 0.66, 95% CI: 0.52-0.84, P=0.001), TLR (OR 0.61, 95% CI: 0.43-0.87, P=0.006), and TVR (OR 0.61, 95% CI: 0.41-0.90, P=0.013). IVUS-guided percutaneous coronary intervention was associated with better overall clinical outcomes than angiography-guided DES implantation. However, in a solely RCT meta-analysis, this benefit was mainly driven by reduced rates of revascularizations. Copyright © 2016. Published by Elsevier Ireland Ltd.

  16. Assessing the Association between Natural Food Folate Intake and Blood Folate Concentrations: A Systematic Review and Bayesian Meta-Analysis of Trials and Observational Studies

    Directory of Open Access Journals (Sweden)

    Claire M. Marchetta

    2015-04-01

    Full Text Available Folate is found naturally in foods or as synthetic folic acid in dietary supplements and fortified foods. Adequate periconceptional folic acid intake can prevent neural tube defects. Folate intake impacts blood folate concentration; however, the dose-response between natural food folate and blood folate concentrations has not been well described. We estimated this association among healthy females. A systematic literature review identified studies (1 1992–3 2014 with both natural food folate intake alone and blood folate concentration among females aged 12–49 years. Bayesian methods were used to estimate regression model parameters describing the association between natural food folate intake and subsequent blood folate concentration. Seven controlled trials and 29 observational studies met the inclusion criteria. For the six studies using microbiologic assay (MA included in the meta-analysis, we estimate that a 6% (95% Credible Interval (CrI: 4%, 9% increase in red blood cell (RBC folate concentration and a 7% (95% CrI: 1%, 12% increase in serum/plasma folate concentration can occur for every 10% increase in natural food folate intake. Using modeled results, we estimate that a natural food folate intake of ≥450 μg dietary folate equivalents (DFE/day could achieve the lower bound of an RBC folate concentration (~1050 nmol/L associated with the lowest risk of a neural tube defect. Natural food folate intake affects blood folate concentration and adequate intakes could help women achieve a RBC folate concentration associated with a risk of 6 neural tube defects/10,000 live births.

  17. Evaluation of a randomized controlled trial in the management of chronic lower back pain in a French automotive industry: an observational study.

    Science.gov (United States)

    Nassif, Hala; Brosset, Nicolas; Guillaume, Marion; Delore-Milles, Emilie; Tafflet, Muriel; Buchholz, Frédéric; Toussaint, Jean-François

    2011-12-01

    To evaluate a specific workplace intervention for the management of chronic lower back pain among employees working in assembly positions in the automotive industry. Randomized controlled trial. On site at the workplace of a French automotive manufacturer. Subjects (N=75 volunteers) were recruited on site and randomly assigned to either an experimental group (n=37) or a control group (n=38). The experimental group followed a supervised 60-minute session, 3 times per week, of muscle strengthening, flexibility, and endurance training during 2 months. The control group received no direct intervention. Evaluation took place at baseline, 2 months, and 6 months. Pain related parameters were evaluated using validated questionnaires and scales translated into French (Quebec Back Pain Disability Scale, Rolan Morris Disability Questionnaire, Dallas Pain Questionnaire, and the Tampa Scale for Kinesiophobia). Perceived pain intensity was evaluated using the numerical rating scale, and physical outcome measures were evaluated using specific indicators (flexibility, Biering-Sorensen Test, Shirado test). The multivariate analysis of variance, t test, and Wilcoxon signed-rank test were used for statistical analysis. We observed a significant beneficial effect (P<.025) for the experimental group at 2 and 6 months in pain parameters, specific flexibility, and in back functions, and a significant improvement at 6 months in the control group for the perceived pain intensity, anterior flexion, flexibility of quadriceps, and Dallas Pain Questionnaire's work recreational score. An increase in the practice of physical activity outside the workplace was noted in both groups at 2 months but persisted at 6 months for the experimental group. This study reinforces the multiple health benefits of physical activity and physical therapy modalities in the workplace by assisting individuals at risk who have chronic LBP. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by

  18. Designing observer trials for image fusion experiments with Latin Squares

    Science.gov (United States)

    Michaelsen, Eckart; Schwan, Gabriele; Scherer-Negenborn, Norbert

    2017-05-01

    Multisensor image fusion (e.g. IR with visual) is the process of combining relevant information from two or more images into a single image. The aim is to find an objective quality measure, which can be used in automatic applications, that correlates best with subjective observer trials. Not all combinations of image, algorithm, and test observer can be worked out. In this paper R. Fisher's Design of Experiments approach based on Latin Squares is used for thinning out the number of experiments for each observer in such observer trials while preserving exactness and reliability of the result.

  19. Moving a randomized clinical trial into an observational cohort.

    Science.gov (United States)

    Goodman, Phyllis J; Hartline, Jo Ann; Tangen, Catherine M; Crowley, John J; Minasian, Lori M; Klein, Eric A; Cook, Elise D; Darke, Amy K; Arnold, Kathryn B; Anderson, Karen; Yee, Monica; Meyskens, Frank L; Baker, Laurence H

    2013-02-01

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled prostate cancer prevention study funded by the National Cancer Institute (NCI) and conducted by the Southwest Oncology Group (SWOG). A total of 35,533 men were assigned randomly to one of the four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, and placebo + placebo). The independent Data and Safety Monitoring Committee (DSMC) recommended the discontinuation of study supplements because of the lack of efficacy for risk reduction and because futility analyses demonstrated no possibility of benefit of the supplements to the anticipated degree (25% reduction in prostate cancer incidence) with additional follow-up. Study leadership agreed that the randomized trial should be terminated but believed that the cohort should be maintained and followed as the additional follow-up would contribute important information to the understanding of the biologic consequences of the intervention. Since the participants no longer needed to be seen in person to assess acute toxicities or to be given study supplements, it was determined that the most efficient and cost-effective way to follow them was via a central coordinated effort. A number of changes were necessary at the local Study Sites and SELECT Statistical Center to transition to following participants via a Central Coordinating Center. We describe the transition process from a randomized clinical trial to the observational Centralized Follow-Up (CFU) study. The process of transitioning SELECT, implemented at more than 400 Study Sites across the United States, Canada, and Puerto Rico, entailed many critical decisions and actions including updates to online documents such as the SELECT Workbench and Study Manual, a protocol amendment, reorganization of the Statistical Center, creation of a Transition Committee, development of materials for SELECT Study Sites, development of procedures

  20. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

  1. Antihypertensive drugs, prevention of cognitive decline and dementia: a systematic review of observational studies, randomized controlled trials and meta-analyses, with discussion of potential mechanisms.

    Science.gov (United States)

    Rouch, Laure; Cestac, Philippe; Hanon, Olivier; Cool, Charlène; Helmer, Catherine; Bouhanick, Béatrice; Chamontin, Bernard; Dartigues, Jean-Franҫois; Vellas, Bruno; Andrieu, Sandrine

    2015-02-01

    Chronic hypertension, particularly midlife high blood pressure, has been associated with an increased risk for cognitive decline and dementia. In this context, antihypertensive drugs might have a preventive effect, but the association remains poorly understood. The aim of this systematic review was to examine all published findings that investigated this relationship and discuss the mechanisms underlying the potential benefits of antihypertensive medication use. A literature search was conducted using MEDLINE, Embase, and the Cochrane Library for publications from 1990 onwards mentioning hypertension, antihypertensive drugs, cognitive decline, and dementia. A total of 38 relevant publications, corresponding to 18 longitudinal studies, 11 randomized controlled trials, and nine meta-analyses were identified from the 10,251 articles retrieved in the literature search. In total, 1,346,176 subjects were included in these studies; the average age was 74 years. In the seven longitudinal studies assessing the effect of antihypertensive medication on cognitive impairment or cognitive decline, antihypertensive drugs appeared to be beneficial. Of the 11 longitudinal studies that assessed the effect of antihypertensive medication on incidence of dementia, only three did not find a significant protective effect. Antihypertensive medication could decrease the risk of not only vascular dementia but also Alzheimer's disease. Four randomized controlled trials showed a potentially preventive effect of antihypertensive drugs on the incidence of dementia or cognitive decline: SYST-EUR (Systolic Hypertension in Europe Study) I and II, with a 55% reduction in dementia risk (3.3 vs. 7.4 cases per 1,000 patient years; pPrevention Evaluation), with a 41% reduction in cognitive decline associated with stroke (95% confidence interval [CI] 6-63); and PROGRESS (Perindopril Protection against Recurrent Stroke Study), with a 19% reduction in cognitive decline (95% CI 4-32; p=0.01). Meta

  2. The REDUCE Follow-Up Study: low rate of new prostate cancer diagnoses observed during a 2-year, observational, followup study of men who participated in the REDUCE trial.

    Science.gov (United States)

    Grubb, Robert L; Andriole, Gerald L; Somerville, Matthew C; Mahoney, Chrysa; Manyak, Michael J; Castro, Ramiro

    2013-03-01

    The primary objective of the REDUCE (REduction by DUtasteride of prostate Cancer Events) Follow-Up Study was to collect data on the occurrence of newly diagnosed prostate cancers for 2 years beyond the 4-year REDUCE study. The 4-year REDUCE study evaluated prostate cancer risk reduction in men taking dutasteride. This 2-year observational study followed men from REDUCE with a clinic visit shortly after study conclusion and with up to 2 annual telephone calls during which patient reported data were collected regarding prostate cancer events, chronic medication use, prostate specific antigen levels and serious adverse events. No study drug was provided and all biopsies during the 2-year followup were performed for cause. The primary objective was to collect data on the occurrence of new biopsy detectable prostate cancers. Secondary end points included assessment of Gleason score and serious adverse events. A total of 2,751 men enrolled in the followup study with numbers similar to those of the REDUCE former treatment groups (placebo and dutasteride). Few new prostate cancers were detected during the 2-year followup period in either former treatment group. A greater number of cancers were detected in the former dutasteride group than in the former placebo group (14 vs 7 cases). No Gleason score 8-10 prostate cancers were detected in either former treatment group based on central pathology review. No new safety issues were identified during the study. Two years of followup of the REDUCE study cohort demonstrated a low rate of new prostate cancer diagnoses in the former placebo and dutasteride treated groups. No new Gleason 8-10 cancers were detected. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  3. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    with inverse variance random effects meta-analysis and explored reasons for variation in ratios of odds ratios with meta-regression. We also analysed rates of agreement between blinded and non-blinded assessors and calculated the number of patients needed to be reclassified to neutralise any bias. DATA SOURCES......: PubMed, Embase, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press, and Google Scholar. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised clinical trials with blinded and non-blinded assessment of the same binary outcome. RESULTS: We included 21 trials in the main...... patients per trial (1-7%). CONCLUSIONS: On average, non-blinded assessors of subjective binary outcomes generated substantially biased effect estimates in randomised clinical trials, exaggerating odds ratios by 36%. This bias was compatible with a high rate of agreement between blinded and non...

  4. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies

    DEFF Research Database (Denmark)

    Kirtane, Ajay J; Gupta, Anuj; Iyengar, Srinivas

    2009-01-01

    .97), and target vessel revascularization (HR, 0.54; 95% CI, 0.48 to 0.61) compared with BMS. CONCLUSIONS: In RCTs, no significant differences were observed in the long-term rates of death or myocardial infarction after DES or BMS use for either off-label or on-label indications. In real-world nonrandomized...... observational studies with greater numbers of patients but the admitted potential for selection bias and residual confounding, DES use was associated with reduced death and myocardial infarction. Both RCTs and observational studies demonstrated marked and comparable reductions in target vessel revascularization...

  5. Importance of observational studies in clinical practice.

    Science.gov (United States)

    Ligthelm, Robert J; Borzì, Vito; Gumprecht, Janusz; Kawamori, Ryuzo; Wenying, Yang; Valensi, Paul

    2007-06-01

    In this era of evidence-based medicine, clinicians require a comprehensive range of well-designed studies to support prescribing decisions and patient management. In recent years, data from observational studies have become an increasingly important source of evidence because of improvements in observational-study methods and advances in statistical analysis. This article reviews the current literature and reports some of the key studies indicating that observational studies can both complement and build on the evidence base established by randomized controlled trials (RCTs). A literature search using the MEDLINE/PubMed database (years: 1966-present) was carried out using the search terms observational or observational study(ies), historical control, nonrandomized, and postmarketing surveillance. All references comparing observational studies with randomized controlled trials were obtained and reviewed and were also hand-checked for studies not identified in the database searches. Observational studies play an important role in investigating treatment outcomes. Data from large observational studies can clarify the tolerability profile of marketed medicines. In particular, observational studies can be of benefit in the study of large, heterogeneous patient populations with complex, chronic diseases such as diabetes mellitus. Observational studies have played a key role in supporting the results of Phase III studies of insulin analogues for the treatment of patients with type 1 and type 2 diabetes. Future observational studies in the field of diabetes such as PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation) and IMPROVE will further our understanding of this global pandemic. Well-designed observational studies can play a key role in supporting the evidence base for drugs and therapies. Current evidence suggests that observational studies can be conducted using the same

  6. Strategies to Make Ramadan Fasting Safer in Type 2 Diabetics: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials and Observational Studies.

    Science.gov (United States)

    Lee, Shaun Wen Huey; Lee, Jun Yang; Tan, Christina San San; Wong, Chee Piau

    2016-01-01

    Ramadan is the holy month for Muslims whereby they fast from predawn to after sunset and is observed by all healthy Muslim adults as well as a large population of type 2 diabetic Muslims.To determine the comparative effectiveness of various strategies that have been used for type 2 diabetic Muslim who fast during Ramadan.A systematic review and network meta-analysis of randomized controlled studies (RCT) as well as observational studies for patients with type 2 diabetes who fasted during Ramadan was conducted. Eight databases were searched from January 1980 through October 2015 for relevant studies. Two reviewers independently screened and assessed study for eligibility, assessed the risk of bias, and extracted relevant data. A network meta-analysis for each outcome was fitted separately, combining direct and indirect evidence for each comparison.Twenty-nine studies, 16 RCTs and 13 observational studies each met the inclusion criteria. The most common strategy used was drug changes during the Ramadan period, which found that the use of DPP-4 (Dipeptidyl peptidase inhibitor -4) inhibitors were associated with a reduction in incidence of experiencing hypoglycemia during Ramadan in both RCTs (pooled relative risk: 0.56; 95% confidence interval: 0.44-0.72) as well as in observational studies (pooled relative risk: 0.27; 0.09-0.75). Ramadan-focused education was shown to be beneficial in reducing hypoglycemia in observational studies but not RCTs (0.25 versus 1.00). Network meta-analyses suggest that incretin mimetics can reduce the risk of hypoglycemia by nearly 1.5 times.The newer antidiabetic agents appear to lower the risk of hypoglycemia and improved glycemic control when compared with sulfonylureas. Ramadan-focused education shows to be a promising strategy but more rigorous examination from RCTs are required.

  7. Variation of growth in the production of the BCG vaccine and the association with the immune response. An observational study within a randomised trial

    DEFF Research Database (Denmark)

    Biering-Sørensen, Sofie; Jensen, Kristoffer Jarlov; Aamand, Susanne Havn

    2015-01-01

    INTRODUCTION: Bacille Calmette-Guérin (BCG) vaccine has beneficial non-specific effects on overall survival. After BCG vaccination, positive PPD response and scar formation are associated with increased survival. During a trial randomising low-birth-weight neonates to BCG at birth or the usual de...... in the production of BCG vaccine may influence important immunological effects of the vaccine. TRIAL REGISTRATION: clinicaltrials.gov (NCT00625482).......INTRODUCTION: Bacille Calmette-Guérin (BCG) vaccine has beneficial non-specific effects on overall survival. After BCG vaccination, positive PPD response and scar formation are associated with increased survival. During a trial randomising low-birth-weight neonates to BCG at birth or the usual...

  8. Significant improvement of olfactory performance in sleep apnea patients after three months of nasal CPAP therapy - Observational study and randomized trial.

    Science.gov (United States)

    Boerner, Bettina; Tini, Gabrielo M; Fachinger, Patrick; Graber, Sereina M; Irani, Sarosh

    2017-01-01

    The olfactory function highly impacts quality of life (QoL). Continuous positive airway pressure is an effective treatment for obstructive sleep apnea (OSA) and is often applied by nasal masks (nCPAP). The influence of nCPAP on the olfactory performance of OSA patients is unknown. The aim of this study was to assess the sense of smell before initiation of nCPAP and after three months treatment, in moderate and severe OSA patients. The sense of smell was assessed in 35 patients suffering from daytime sleepiness and moderate to severe OSA (apnea/hypopnea index ≥ 15/h), with the aid of a validated test battery (Sniffin' Sticks) before initiation of nCPAP therapy and after three months of treatment. Additionally, adherent subjects were included in a double-blind randomized three weeks CPAP-withdrawal trial (sub-therapeutic CPAP pressure). Twenty five of the 35 patients used the nCPAP therapy for more than four hours per night, and for more than 70% of nights (adherent group). The olfactory performance of these patients improved significantly (p = 0.007) after three months of nCPAP therapy. When considering the entire group of patients, olfaction also improved significantly (p = 0.001). In the randomized phase the sense of smell of six patients deteriorated under sub-therapeutic CPAP pressure (p = 0.046) whereas five patients in the maintenance CPAP group showed no significant difference (p = 0.501). Olfactory performance improved significantly after three months of nCPAP therapy in patients suffering from moderate and severe OSA. It seems that this effect of nCPAP is reversible under sub-therapeutic CPAP pressure. ISRCTN11128866.

  9. Significant improvement of olfactory performance in sleep apnea patients after three months of nasal CPAP therapy - Observational study and randomized trial.

    Directory of Open Access Journals (Sweden)

    Bettina Boerner

    Full Text Available The olfactory function highly impacts quality of life (QoL. Continuous positive airway pressure is an effective treatment for obstructive sleep apnea (OSA and is often applied by nasal masks (nCPAP. The influence of nCPAP on the olfactory performance of OSA patients is unknown. The aim of this study was to assess the sense of smell before initiation of nCPAP and after three months treatment, in moderate and severe OSA patients.The sense of smell was assessed in 35 patients suffering from daytime sleepiness and moderate to severe OSA (apnea/hypopnea index ≥ 15/h, with the aid of a validated test battery (Sniffin' Sticks before initiation of nCPAP therapy and after three months of treatment. Additionally, adherent subjects were included in a double-blind randomized three weeks CPAP-withdrawal trial (sub-therapeutic CPAP pressure.Twenty five of the 35 patients used the nCPAP therapy for more than four hours per night, and for more than 70% of nights (adherent group. The olfactory performance of these patients improved significantly (p = 0.007 after three months of nCPAP therapy. When considering the entire group of patients, olfaction also improved significantly (p = 0.001. In the randomized phase the sense of smell of six patients deteriorated under sub-therapeutic CPAP pressure (p = 0.046 whereas five patients in the maintenance CPAP group showed no significant difference (p = 0.501.Olfactory performance improved significantly after three months of nCPAP therapy in patients suffering from moderate and severe OSA. It seems that this effect of nCPAP is reversible under sub-therapeutic CPAP pressure.ISRCTN11128866.

  10. Impact of study design on outcome after endovascular abdominal aortic aneurysm repair. A comparison between the randomized controlled DREAM-trial and the observational EUROSTAR-registry.

    NARCIS (Netherlands)

    Leurs, L.J.; Buth, J.; Harris, P.L.; Blankensteijn, J.D.

    2007-01-01

    BACKGROUND: Patients with abdominal aortic aneurysm (AAA) can be treated by transfemoral endovascular intervention and by conventional open surgery. Level-one evidence of the safety and efficacy of one treatment mode over the other is only provided by a randomised controlled trial (RCT). Results

  11. Variation of growth in the production of the BCG vaccine and the association with the immune response. An observational study within a randomised trial

    NARCIS (Netherlands)

    Biering-Sorensen, S.; Jensen, K.J.; Aamand, S.H.; Blok, B.; Andersen, A.; Monteiro, I.; Netea, M.G.; Aaby, P.; Benn, C.S.; Haslov, K.R.

    2015-01-01

    INTRODUCTION: Bacille Calmette-Guerin (BCG) vaccine has beneficial non-specific effects on overall survival. After BCG vaccination, positive PPD response and scar formation are associated with increased survival. During a trial randomising low-birth-weight neonates to BCG at birth or the usual

  12. Radiation-induced emesis: a prospective observational multicenter Italian trial

    International Nuclear Information System (INIS)

    1999-01-01

    Purpose: A prospective observational multicenter trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and evaluate the use of antiemetic drugs in radiation oncology clinical practice. Methods and Materials: Fifty-one Italian radiation oncology centers took part in this trial. The accrual lasted 2 consecutive weeks, only patients starting radiotherapy in this period were enrolled. Exclusion criteria were age under 18 years, and concomitant chemotherapy. Evaluation was based on diary cards filled in daily by patients during radiotherapy and 1 week after stopping it. Diary cards recorded the intensity of nausea and any episode of vomiting and retching. Prophylactic and symptomatic antiemetic drug prescriptions were also registered. Results: Nine hundred thirty-four patients entered the trial, and 914 were evaluable. Irradiated sites were: breast in 211 patients, pelvis in 210 patients, head and neck in 136 patients, thorax in 129 patients, brain in 52 patients, upper abdomen in 42 patients, skin and/or extremities in 37 patients, and other sites in 97 patients. Vomiting and nausea occurred in 17.1% and 37.3% of patients, respectively, and 38.7% patients had both vomiting and nausea. At multifactorial analysis, the only patient-related risk factor that was statistically significant was represented by previous experience with cancer chemotherapy. Moreover, two radiotherapy (RT)-related factors were significant risk factors for RIE, the irradiated site and field size. In fact, a statistically significant higher percentage of RIE was registered in upper abdomen RT and RT fields > 400 cm 2 . Although nonstatistically significant, patients receiving RT to the thorax and head and neck presented a higher incidence of RIE. Only a minority (14%) of patients receiving RT were given an antiemetic drug, and the prescriptions were more often symptomatic than prophylactic (9% vs. 5%, respectively). Different compounds and

  13. Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania

    Directory of Open Access Journals (Sweden)

    Abel Makubi

    2016-10-01

    Full Text Available Abstract Background Hydroxyurea (HU has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA but poor adherence is a barrier. Directly Observed Therapy (DOT has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA. Methods and design To examine the effect of mobile-directly observed therapy (mDOT on adherence to HU (mDOT-HuA in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged ≥18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher’s exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods. Discussion Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA. Trial registration ClinicalTrials.gov Identifier: NCT02844673 , registered on 25tht July 2016 (retrospectively registered.

  14. Hip fracture risk in relation to vitamin D supplementation and serum 25-hydroxyvitamin D levels: a systematic review and meta-analysis of randomised controlled trials and observational studies

    Directory of Open Access Journals (Sweden)

    Roddam Andrew W

    2010-06-01

    Full Text Available Abstract Background Vitamin D supplementation for fracture prevention is widespread despite conflicting interpretation of relevant randomised controlled trial (RCT evidence. This study summarises quantitatively the current evidence from RCTs and observational studies regarding vitamin D, parathyroid hormone (PTH and hip fracture risk. Methods We undertook separate meta-analyses of RCTs examining vitamin D supplementation and hip fracture, and observational studies of serum vitamin D status (25-hydroxyvitamin D (25(OHD level, PTH and hip fracture. Results from RCTs were combined using the reported hazard ratios/relative risks (RR. Results from case-control studies were combined using the ratio of 25(OHD and PTH measurements of hip fracture cases compared with controls. Original published studies of vitamin D, PTH and hip fracture were identified through PubMed and Web of Science databases, searches of reference lists and forward citations of key papers. Results The seven eligible RCTs identified showed no significant difference in hip fracture risk in those randomised to cholecalciferol or ergocalciferol supplementation versus placebo/control (RR = 1.13[95%CI 0.98-1.29]; 801 cases, with no significant difference between trials of 21 (heterogeneity = 51.02, p 216 (heterogeneity = 137.9, p 29 (heterogeneity = 149.68, p Conclusions Neither higher nor lower dose vitamin D supplementation prevented hip fracture. Randomised and observational data on vitamin D and hip fracture appear to differ. The reason for this is unclear; one possible explanation is uncontrolled confounding in observational studies. Post-fracture PTH levels are unrelated to hip fracture risk.

  15. After the FLUSH trial: a prospective observational study of lipiodol flushing as an innovative treatment for unexplained and endometriosis-related infertility.

    Science.gov (United States)

    Brent, Kira; Hadden, Wendy E; Weston-Webb, Marianne; Johnson, Neil P

    2006-08-01

    To assess the demographics, efficacy and safety of lipiodol flushing fertility treatment. Prospective observational study. Secondary level care infertility clinic and radiology centre based in Auckland, New Zealand. The first cohort of 100 New Zealand women with infertility to undergo lipiodol flushing as an innovative fertility treatment. Women received lipiodol flushing performed by a hysterosalpingogram technique and were followed up at 6 months. Clinical pregnancy at 6 months post-treatment; and live birth or ongoing pregnancy. The overall pregnancy rate was 30% and the live birth or ongoing pregnancy rate 27%. For women under 40 years old, a 32% pregnancy rate and a 25% live birth or ongoing pregnancy rate were seen in women with unexplained infertility, and a 50% pregnancy rate and a 47% live birth or ongoing pregnancy rate were seen in women with endometriosis. Of women aged 40 years and older, the pregnancy rate was 13% and the live birth or ongoing pregnancy rate was 13%. The pregnancy rates included those occurring after additional interventions, such as intrauterine insemination and in vitro fertilisation, accounting for 12 of the 30 pregnancies. There were no treatment complications. This study provides further evidence of the efficacy and safety of lipiodol flushing fertility treatment.

  16. A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events.

    Science.gov (United States)

    Faillie, Jean-Luc; Ferrer, Pili; Gouverneur, Amandine; Driot, Damien; Berkemeyer, Shoma; Vidal, Xavier; Martínez-Zapata, Maria José; Huerta, Consuelo; Castells, Xavier; Rottenkolber, Marietta; Schmiedl, Sven; Sabaté, Mònica; Ballarín, Elena; Ibáñez, Luisa

    2017-06-01

    The objective of the study was to develop and validate an adequate tool to evaluate the risk of bias of randomized controlled trials, observational studies, and systematic reviews assessing drug adverse events. We developed a structured risk of bias checklist applicable to randomized trials, cohort, case-control and nested case-control studies, and systematic reviews focusing on drug safety. Face and content validity was judged by three experienced reviewers. Interrater and intrarater reliability were determined using 20 randomly selected studies, assessed by three other independent reviewers including one performing a 3-week retest. The developed checklist examines eight domains: study design and objectives, selection bias, attrition, adverse events information bias, other information bias, statistical methods to control confounding, other statistical methods, and conflicts of interest. The total number of questions varied from 10 to 32 depending on the study design. Interrater and intrarater agreements were fair with Kendall's W of 0.70 and 0.74, respectively. Median time to complete the checklist was 8.5 minutes. The developed checklist showed face and content validity and acceptable reliability to assess the risk of bias for studies analyzing drug adverse events. Hence, it might be considered as a novel useful tool for systematic reviews and meta-analyses focusing on drug safety. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Change in organizational justice as a predictor of insomnia symptoms: longitudinal study analysing observational data as a non-randomized pseudo-trial.

    Science.gov (United States)

    Lallukka, Tea; Halonen, Jaana I; Sivertsen, Børge; Pentti, Jaana; Stenholm, Sari; Virtanen, Marianna; Salo, Paula; Oksanen, Tuula; Elovainio, Marko; Vahtera, Jussi; Kivimäki, Mika

    2017-08-01

    Despite injustice at the workplace being a potential source of sleep problems, longitudinal evidence remains scarce. We examined whether changes in perceived organizational justice predicted changes in insomnia symptoms. Data on 24 287 Finnish public sector employees (82% women), from three consecutive survey waves between 2000 and 2012, were treated as 'pseudo-trials'. Thus, the analysis of unfavourable changes in organizational justice included participants without insomnia symptoms in Waves 1 and 2, with high organizational justice in Wave 1 and high or low justice in Wave 2 (N = 6307). In the analyses of favourable changes in justice, participants had insomnia symptoms in Waves 1 and 2, low justice in Wave 1 and high or low justice in Wave 2 (N = 2903). In both analyses, the outcome was insomnia symptoms in Wave 3. We used generalized estimating equation models to analyse the data. After adjusting for social and health-related covariates in Wave 1, unfavourable changes in relational organizational justice (i.e. fairness of managerial behaviours) were associated with increased odds of developing insomnia symptoms [odds ratio = 1.15; 95% confidence interval (CI) 1.02-1.30]. A favourable change in relational organizational justice was associated with lower odds of persistent insomnia symptoms (odds ratio = 0.83; 95% CI 0.71-0.96). Changes in procedural justice (i.e. the fairness of decision-making procedures) were not associated with insomnia symptoms. These data suggest that changes in perceived relational justice may affect employees' sleep quality. Decreases in the fairness of managerial behaviours were linked to increases in insomnia symptoms, whereas rises in fairness were associated with reduced insomnia symptoms. © The Author 2017. Published by Oxford University Press on behalf of the International Epidemiological Association.

  18. Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania.

    Science.gov (United States)

    Makubi, Abel; Sasi, Philip; Ngaeje, Mariam; Novelli, Enrico M; Mmbando, Bruno P; Gladwin, Mark T; Makani, Julie

    2016-10-18

    Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA) but poor adherence is a barrier. Directly Observed Therapy (DOT) has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA. To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged ≥18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM) arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher's exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods. Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA. ClinicalTrials.gov Identifier: NCT02844673 , registered on 25 th t July 2016 (retrospectively registered).

  19. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  20. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

    Directory of Open Access Journals (Sweden)

    Hengwei Jin

    2017-09-01

    Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

  1. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  2. Publication bias in oral and maxillofacial surgery journals: an observation on published controlled trials.

    Science.gov (United States)

    Pitak-Arnnop, Poramate; Sader, Robert; Rapidis, Alexander D; Dhanuthai, Kittipong; Bauer, Ute; Herve, Chistian; Hemprich, Alexander

    2010-01-01

    Publication bias (PB) diminishes the full distribution of research, distorts and discredits the scientific record, and thus compromises evidence-based practice. The objective of this study was to analyse published controlled trials with regard to PB in leading oral and maxillofacial surgery (OMS) journals. All controlled trials published in the International Journal of Oral and Maxillofacial Surgery, Journal of Cranio-Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, and British Journal of Oral and Maxillofacial Surgery in 2008 were analysed for a primary outcome, country of authors, sample size, gender of the first author, funding source and location of the study. Of 952 published articles, 53 controlled trials (5.7%) were identified. The OMS journals preferentially published controlled trials with a positive outcome (77.4%) and from high-income countries (73.6%). Single-centred trials (86.8%) with low sample size (njournals should establish measures to eliminate PB to uphold scientific integrity. However, this study was an observation based on the published articles. An analysis of all submitted manuscripts would provide more accurate estimates of PB. Ethical considerations on PB are also discussed.

  3. The effects of observation of walking in a living room environment, on physical, cognitive, and quality of life related outcomes in older adults with dementia: a study protocol of a randomized controlled trial.

    Science.gov (United States)

    Douma, Johanna G; Volkers, Karin M; Vuijk, Jelle Pieter; Sonneveld, Marieke H; Goossens, Richard H M; Scherder, Erik J A

    2015-03-18

    The number of older adults with dementia is expected to increase. Dementia is not only characterized by a decline in cognition, also other functions, for example, physical functioning change. A possible means to decrease the decline in these functions, or even improve them, could be increasing the amount of physical activity. A feasible way hereto may be activation of the mirror neuron system through action observation. This method has already been shown beneficial for the performance of actions in, for example, stroke patients. The primary aim of this study is to examine the effect of observing videos of walking people on physical activity and physical performance, in older adults with dementia. Secondary, effects on cognition and quality of life related factors will be examined. A cluster randomized controlled trial is being performed, in which videos are shown to older adults with dementia (also additional eligibility criteria apply) in shared living rooms of residential care facilities. Due to the study design, living rooms instead of individual participants are randomly assigned to the experimental (videos of walking people) or control (videos of nature) condition, by means of drawing pieces of paper. The intervention has a duration of three months, and takes place on weekdays, during the day. There are four measurement occasions, in which physical activity, physical functioning, activities of daily living, cognition, the rest-activity rhythm, quality of life, and depression are assessed. Tests for participants are administered by a test administrator who is blind to the group the participant is in. This study examines the effect of the observation of walking people on multiple daily life functions and quality of life related factors in older adults with dementia. A strength of this study is that the intervention does not require much time and attention from caregivers or researchers. A challenge of the study is therefore to get to know for how long residents

  4. The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders.

    Science.gov (United States)

    Jakubovski, Ewgeni; Reichert, Cornelia; Karch, Annika; Buddensiek, Nadine; Breuer, Daniel; Müller-Vahl, Kirsten

    2016-01-01

    In recent years, behavioral therapy with comprehensive behavioral intervention for tics (CBIT) has been recognized as an effective and safe treatment in patients with Gilles de la Tourette syndrome. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated Internet-delivered CBIT (iCBIT) program. With this study, we want to demonstrate that iCBIT is superior to Internet-delivered psychoeducation and comparable to face-to-face CBIT. This is a multicenter, prospective, randomized, controlled, observer-blind clinical trial, which will be conducted at five sites in Germany (ONLINE-TICS). Over the course of 2 years, 160 adult patients with chronic tic disorders will be assigned to one of three treatment arms: iCBIT (n = 72), online psychoeducation (n = 72), or face-to-face CBIT (n = 16). All treatments will consist of eighty therapy sessions over a period of 10 weeks and will follow the well-established CBIT manual by Woods and colleagues. The primary outcome measure will be the change in Yale Global Tic Severity Scale (YGTSS) at 1-week posttreatment. Secondary outcome measures include YGTSS change at 3 and 6 months, video- and self-ratings of tics as well as scales for psychiatric comorbidities assessed at each visit. The primary analysis will compare iCBIT to online psychoeducation using a mixed linear model with the YGTSS change as dependent variable. Secondary analyses will look at the comparison between iCBIT and face-to-face CBIT in a non-inferiority analysis. If iCBIT proves to be effective, it would be a considerable contribution to close the wide gap in treatment providers for tic disorders not only in Germany but also in several other countries, since this Internet-delivered therapy does not require the supervision of a therapist. In addition, iCBIT would be a cost-effective and readily available

  5. Safety of live vaccinations on immunosuppressive therapy in patients with immune-mediated inflammatory diseases, solid organ transplantation or after bone-marrow transplantation - A systematic review of randomized trials, observational studies and case reports.

    Science.gov (United States)

    Croce, Evelina; Hatz, Christoph; Jonker, Emile F; Visser, L G; Jaeger, Veronika K; Bühler, Silja

    2017-03-01

    Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice. To estimate the safety of live vaccinations in patients with immune-mediated inflammatory diseases (IMID) or solid organ transplantation (SOT) on immunosuppressive treatment and in patients after bone-marrow transplantation (BMT). A search was conducted in electronic databases (Cochrane, Pubmed, Embase) and additional literature was identified by targeted searches. Randomized trials, observational studies and case reports. Patients with IMID or SOT on immunosuppressive treatment and BMT patients vaccinations: mumps, measles, rubella (MMR), yellow fever (YF), varicella vaccine (VV), herpes zoster (HZ), oral typhoid, oral polio, rotavirus, Bacillus Calmette-Guérin (BCG), smallpox. One author performed the data extraction using predefined data fields. It was cross-checked by two other authors. 7305 articles were identified and 64 articles were included: 40 on IMID, 16 on SOT and 8 on BMT patients. In most studies, the administration of live vaccines was safe. However, some serious vaccine-related adverse events occurred. 32 participants developed an infection with the vaccine strain; in most cases the infection was mild. However, in two patients fatal infections were reported: a patient with RA/SLE overlap who started MTX/dexamethasone treatment four days after the YFV developed a yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and died. The particular vaccine lot was found to be associated with a more than 20 times risk of YEL-AVD. One infant whose mother was under infliximab treatment during pregnancy received the BCG vaccine at the age of three months and developed disseminated BCG infection and died. An immunogenicity assessment was performed in 43 studies. In most cases the patients developed satisfactory seroprotection rates. In the IMID group, YFV and VV demonstrated high seroconversion rates

  6. The valuable contribution of observational studies to nephrology

    NARCIS (Netherlands)

    Jager, K. J.; Stel, V. S.; Wanner, C.; Zoccali, C.; Dekker, F. W.

    2007-01-01

    In studies on the effects of therapy (or other interventions), the randomized controlled trial (RCT) is an almost unbeatable standard in clinical research. The value of RCTs leaves unabated the valuable contributions of observational studies to medicine. This paper discusses some limitations of RCTs

  7. Marketing and clinical trials: a case study.

    Science.gov (United States)

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

    2007-11-20

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

  8. Poor nutritional status on admission predicts poor outcomes after stroke: observational data from the FOOD trial.

    Science.gov (United States)

    2003-06-01

    Previous studies suggest that undernourished patients with acute stroke do badly. The data, however, are not robust. We aimed to reliably assess the importance of baseline nutritional status as an independent predictor of long-term outcome after stroke in a large prospective cohort enrolled in the Feed Or Ordinary Diet (FOOD) trial, a multicenter randomized trial evaluating various feeding policies. Patients admitted to hospital with a recent stroke were enrolled in the FOOD trial. Data on nutritional status and other clinical predictors of outcome were collected at trial entry. At 6 months, the coordinating center collected data on survival and functional status (modified Rankin Scale). Outcome assessment was done by researchers blinded to baseline assessments and treatment allocation. Between November 1996 and November 2001, 3012 patients were enrolled, and 2955 (98%) were followed up. Of the 275 undernourished patients, 102 (37%) were dead by final follow-up compared with only 445 (20%) of 2194 patients of normal nutritional status (odds ratio [OR], 2.32; 95% CI, 1.78 to 3.02). After adjustment for age, prestroke functional state, and stroke severity, this relationship, although weakened, still held (OR, 1.82; 95% CI, 1.34 to 2.47). Undernourished patients were more likely to develop pneumonia, other infections, and gastrointestinal bleeding during their hospital admission than other patients. These data provide reliable evidence that nutritional status early after stroke is independently associated with long-term outcome. It supports the rationale for the FOOD trial, which continues to recruit and aims to estimate the effect of different feeding regimes on outcome after stroke and thus determine whether the association observed in this study is likely to be causal.

  9. PHEDRE trial protocol - observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population.

    Science.gov (United States)

    Gérardin, Marie; Couec, Marie-Laure; Grall-Bronnec, Marie; Feuillet, Fanny; Wainstein, Laura; Rousselet, Morgane; Pinot, Marie-Lyne; Perrouin, Fanny; Bonnot, Olivier; Drouineau, Marie-Hélène; Jolliet, Pascale; Victorri-Vigneau, Caroline

    2015-11-14

    The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to differentiate the symptoms occurring only in a context of pain, in the aim of managing the pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no pain, and more in favour of true addiction. Currently there is no data available in France on this problem, and no studies have been carried out in children or adolescents with sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a population of subjects with severe sickle-cell disease in France. PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an observational, descriptive and transversal study. Patients under the age of 26 with sickle-cell disease are included in the study by the doctors looking after them in sickle-cell disease centres. The patients are then contacted by a trained researcher for a telephone interview, including an evaluation of the Diagnostic and Statistical Manual of Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also completed using the subject's medical record. This study will make it possible to provide an initial quantitative and qualitative evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic drugs in the sickle-cell disease population. The results will be used firstly to provide additional data essential

  10. Observational Study of Travelers' Diarrhea.

    Science.gov (United States)

    Meuris

    1995-03-01

    Background: European air travelers returning from Algeria, Egypt, Mexico, Morocco, and Tunisia were interviewed about their experience of travelers' diseases upon arrival in Brussels. Diarrhea was mentioned by 37% of the adults and 27% of the children. These subjects were questioned about the types of measures taken, type and duration of drug treatment (if any), and about duration of diarrhea and side effects experienced. Methods: Final analysis was performed based on 2160 interviews. The largest proportion of diarrhea was reported in the age group 15-24 years (46%). Results: The majority of the 2160 subjects had opted for drug treatment (81%): 927 subjects for loperamide alone, 235 for loperamide in combination with nifuroxazide, and 178 for nifuroxazide alone. Other drugs had been used less frequently. The median time to recovery was 2.4 days with loperamide compared to 3.2 days with nifuroxazide and to 3.4 days for the no-treatment group. Conclusions: A stratification of the results by severity of the diarrhea suggests a rank of antidiarrheal potency as follows: loperamide > nifuroxazide > no-drug treatment. The side effect with the highest incidence was constipation (2.4% with loperamide). (J Travel Med 2:11-15, 1995) Travelers' diarrhea is usually defined as the passage of at least three unformed stools per day or any number of such stools when accompanied by fever, abdominal cramping, or vomiting. The definition may be broadened to include more trivial bowel disturbance.1,2 The duration of this self-limited disease generally is 3 to 5 days. Medical intervention aims at shortening the duration of disease, thus allowing the sufferer to resume his or her usual activities at an early stage. A shortened period of recovery to physical well-being has obvious favorable economic implications if the traveler is on business and may help the maintenance of a desired level of quality of life while a traveler is on holiday. An observational study of various medical

  11. Evaluation of the Quality of Reporting of Observational Studies in Otorhinolaryngology - Based on the STROBE Statement

    NARCIS (Netherlands)

    Hendriksma, Martine; Joosten, Michiel H M A; Peters, Jeroen P M; Grolman, Wilko; Stegeman, Inge

    2017-01-01

    BACKGROUND: Observational studies are the most frequently published studies in literature. When randomized controlled trials cannot be conducted because of ethical or practical considerations, an observational study design is the first choice. The STROBE Statement (STrengthening the Reporting of

  12. Bridging case-control studies and randomized trials

    Directory of Open Access Journals (Sweden)

    Rosendaal Frits R

    2001-05-01

    Full Text Available Abstract Randomized trials and observational studies, such as case-control studies, are often seen as opposing approaches. However, in many instances results obtained by different designs may complement each other. For instance, case-control studies on aetiology of disease may help to give the direction of future trials. In this commentary, the author discusses the purpose of randomization and observation, and under which conditions one design may be preferred to another. Randomization is useful to combat 'confounding by indication', and is therefore the design of choice for most therapeutic trials. When this confounding is not an issue, as in studies of genetic risk factors or side-effects, then case-control studies are preferred.

  13. UFOs: Observations, Studies and Extrapolations

    CERN Document Server

    Baer, T; Barnes, M J; Bartmann, W; Bracco, C; Carlier, E; Cerutti, F; Dehning, B; Ducimetière, L; Ferrari, A; Ferro-Luzzi, M; Garrel, N; Gerardin, A; Goddard, B; Holzer, E B; Jackson, S; Jimenez, J M; Kain, V; Zimmermann, F; Lechner, A; Mertens, V; Misiowiec, M; Nebot Del Busto, E; Morón Ballester, R; Norderhaug Drosdal, L; Nordt, A; Papotti, G; Redaelli, S; Uythoven, J; Velghe, B; Vlachoudis, V; Wenninger, J; Zamantzas, C; Zerlauth, M; Fuster Martinez, N

    2012-01-01

    UFOs (“ Unidentified Falling Objects”) could be one of the major performance limitations for nominal LHC operation. Therefore, in 2011, the diagnostics for UFO events were significantly improved, dedicated experiments and measurements in the LHC and in the laboratory were made and complemented by FLUKA simulations and theoretical studies. The state of knowledge is summarized and extrapolations for LHC operation in 2012 and beyond are presented. Mitigation strategies are proposed and related tests and measures for 2012 are specified.

  14. Using the STROBE Statement to Assess Reporting of Observational Trials in Hand Surgery

    Science.gov (United States)

    Sorensen, Amelia A.; Wojahn, Robert D.; Manske, Mary Claire; Calfee, Ryan P.

    2014-01-01

    Purpose To use the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement checklist to critically evaluate the change in quality of observational trial reporting in the Journal of Hand Surgery American between 2005 and 2011. Methods A cross-sectional analysis of observational studies published in Journal of Hand Surgery American was designed to sample 2 6-month periods of publication (March 2005 - August 2005 and June 2011 - November 2011). Fifty-one items were extracted from the STROBE statement for evaluation. Overall STROBE compliance rates for articles and specific checklist items were determined. Final compliance percentages from each period were compared by Student t-testing. Changes in item compliance over time were quantified. Results Overall compliance with the STROBE statement was 38% (range, 10-54%) in 2005 and 58% (range, 39%-85%) for 2011 manuscripts representing a significant improvement. Seventy-five percent or greater of articles (2005/2011) provided the explicit reporting of background (100%/97%), follow-up time (85%/94%), overall interpretation of data (100%/94%), and results of similar studies (95%/89%). Twenty-five percent or less of articles provided the study design in the abstract (10%/20%), a clear description of the study's setting (10%/23%), the handling of missing data (0%/6%), the potential directions of bias (5%/11%) and use of a power analysis (0%/17%). Eighty-six percent (44/51) of items were more frequently satisfied in 2011 articles compared to 2005 publications. Absolute increases in compliance rates of ≥40% were noted in 10 items (20%) with no worsening in compliance for an individual item over 6%. Discussion The overall quality of the reporting of observational trials in Journal of Hand Surgery American improved from 2005 to 2011. Current observational trials in hand surgery could still benefit from increased reporting of methodologic details including the use of power analyses, the handling of

  15. Massage has no observable effect on distress in children with burns: A randomized, observer-blinded trial.

    Science.gov (United States)

    van Dijk, Monique; O'Flaherty, Linda Anne; Hoedemaker, Tessa; van Rosmalen, Joost; Rode, Heinz

    2018-02-01

    In a previous observational study we found that massage therapy reduced anxiety and stress in pediatric burn patients. We aimed to test this effect in a randomized controlled trial. To determine whether (1) aromatherapy massage can provide relaxation to hospitalized children with burns; (2) massage with aromatherapy oil is more effective than without; and (3) massage sessions are more effective when repeated. Randomized controlled clinical trial with 3 arms conducted in a burns unit from April 2013 to December 2014 in Cape Town, South Africa. Massage with carrier oil, massage with aromatherapy oil, and standard nursing care only. Scores on the Muscle Tension Inventory (MTI) and Behavioral Relaxation Scale (BRS) to assess level of relaxation. Scores on the COMFORT behaviour scale and Numeric Rating Scale Distress to assess level of distress. Secondary outcomes were heart rate and oxygen saturation levels. Linear mixed models were used to determine the effect of condition and session number (1 to a maximum of 5 sessions per child) correcting for baseline outcomes of COMFORT behaviour scores and heart rates after sessions. Secondary analyses included the addition of sex, age, and total body surface area (TBSA) burned as covariates. We included 284 children aged 5 weeks to 13 years with TBSA burned between 10 and 45%. Two-thirds (65.5%) were under the age of 3 years. Mixed model analyses revealed no significant difference in reduction of COMFORT behavior scores (p=0.18), or heart rates (p=0.18) between the three study arms. These outcomes were also not associated with the session number (p=0.92 and p=0.13, respectively). Level of relaxation could not be reliably assessed with the MTI and BRS because 119 patients (41.9%) had bandages covering the larger part of the face, and in 40.1% of cases the child was not in the required position. Massage therapy with or without essential oil was not effective in reducing distress behavior or heart rate in hospitalized children

  16. Risk of bias and brand explain the observed inconsistency in trials on glucosamine for symptomatic relief of osteoarthritis

    DEFF Research Database (Denmark)

    Eriksen, Patrick; Bartels, Else M; Altman, Roy D

    2014-01-01

    OBJECTIVE: To determine whether study sponsor, chemical formulation, brand of glucosamine, and/or risk of bias explain observed inconsistencies in trials of glucosamine's efficacy for treating pain in osteoarthritis (OA). METHODS: A systematic review and stratified meta-analysis of randomized...... placebo-controlled trials was performed, and random-effects models were applied with inconsistency (I(2) ) and heterogeneity (tau(2) ) estimated using Review Manager and SAS, respectively. The major outcome was reduction of pain; the standardized mean difference (SMD [95% confidence interval (95% CI......) was brand, reducing heterogeneity by 41% (P = 0.00032). Twelve trials (1,437 patients) using the Rottapharm/Madaus product resulted in significant pain reduction (SMD -1.07 [95% CI -1.47, -0.67]), although a sensitivity analysis of 3 low risk of bias trials using the Rottapharm/Madaus product showed less...

  17. Transfusion practice and complications after laparotomy - an observational analysis of a randomized clinical trial

    DEFF Research Database (Denmark)

    Nielsen, Kamilla; Meyhoff, C S; Johansson, P I

    2012-01-01

    Background  Transfusion of allogeneic red blood cells (RBC) may be associated with side effects. This study aimed to assess whether an association could be detected between transfusion practice and the occurrence of complications after laparotomy. Study design and methods  This study...... is an observational analysis of data from a randomized trial in 1400 patients who underwent laparotomy. A subgroup of 224 transfused patients with an intraoperative blood loss ≥200 ml were included in the analysis. Logistic regression analysis was used to investigate risk factors for postoperative complications....... The ratio of intraoperative RBC transfusion to blood loss was computed, and patients grouped by the median into a liberal transfusion practice (ratio equal to or above the median) and a restrictive transfusion practice group (ratio below the median). Results  Surgical site infection occurred in 27...

  18. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  19. Effectiveness of electric toothbrushing in patients with neuromuscular disability: A randomized observer-blind crossover trial.

    Science.gov (United States)

    Ikeda, Tokuhei; Yoshizawa, Kunio; Takahashi, Kazuya; Ishida, Chiho; Komai, Kiyonobu; Kobayashi, Kazuhiko; Sugiura, Shirou

    2016-01-01

    To evaluate the effectiveness of an electric toothbrush for oral care in patients with neuromuscular disability. In this randomized observer-blind crossover trial, 30 patients with neuromuscular disease performed either electric or manual toothbrushing each for 4 weeks. Plaque status (plaque control record), periodontal pocket depth, oral status (oral assessment guide), salivary bacterial count, and toothbrushing time were assessed after each period and compared between the two groups by Wilcoxon signed-rank test. Twenty-eight patients completed the study, including 18 communicative patients. Periodontal pockets were significantly shallower and toothbrushing time was significantly shorter with electric toothbrush use than with manual toothbrush use. No significant differences in oral status and salivary bacterial counts were noted between the approaches, but plaque status significantly improved after electric toothbrushing in communicative patients. Electric toothbrushing is beneficial for maintaining oral health in patients with neuromuscular disability and reducing the caregivers' oral care burden. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

  20. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    Science.gov (United States)

    Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

    2015-01-01

    Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively). Conclusion Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations. PMID:26016754

  1. Confounding in publications of observational intervention studies

    NARCIS (Netherlands)

    Groenwold, Rolf H. H.; Hoes, Arno W.; Hak, Eelko

    We conducted a systematic literature search in Medline to assess the proportion of observational intervention studies appreciating confounding bias in peer-reviewed medical literature from 1985 through 2005. This study shows only 9% of all papers on observational intervention studies published in

  2. STROBE initiative: guidelines on reporting observational studies.

    Science.gov (United States)

    Malta, Monica; Cardoso, Leticia Oliveira; Bastos, Francisco Inacio; Magnanini, Monica Maria Ferreira; Silva, Cosme Marcelo Furtado Passos da

    2010-06-01

    Reporting of observational studies is often inadequate, hampering the assessment of their strengths and weaknesses and, consequently, the generalization of study results. The initiative named Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) developed a checklist of 22 items, the STROBE Statement, with recommendations about what should be included in a more accurate and complete description of observational studies. Between June and December 2008, a group of Brazilian researchers was dedicated to the translation and adaptation of the STROBE Statement into Portuguese. The present study aimed to show the translation into Portuguese, introduce the discussion on the context of use, the potential and limitations of the STROBE initiative.

  3. AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff.

    Science.gov (United States)

    Bernhardt, Julie; Lindley, Richard I; Lalor, Erin; Ellery, Fiona; Chamberlain, Jan; Van Holsteyn, John; Collier, Janice M; Dewey, Helen M; Parsons, Brooke; Moodie, Marjory; Lennon, Sheila; Donnan, Geoffrey A; Thrift, Amanda G; Churilov, Leonid; Langhorne, Peter

    2015-12-11

    To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences. Retrospective observational analysis. 56 acute stroke hospitals in eight countries. 1074 trial physiotherapists, nurses, and other clinicians. Number of babies born during trial recruitment per trial participant recruited. With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average. The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group. Australian New Zealand Clinical Trials Registry no 12606000185561. Participation in a rehabilitation trial does not guarantee successful reproductive activity. 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.

  4. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

    2016-03-07

    A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity

  5. Comparison of intravascular ultrasound versus angiography-guided drug-eluting stent implantation: A meta-analysis of one randomised trial and ten observational studies involving 19,619 patients

    NARCIS (Netherlands)

    Y. Zhang (Yaojun); V. Farooq (Vasim); H.M. Garcia-Garcia (Hector); C.V. Bourantas (Christos); N.-L. Tian (Nai-Liang); S.-J. Dong (Sheng-Jie); M. Li (Minghui); S. Yang (Shengyun); P.W.J.C. Serruys (Patrick); S.-L. Chen (Shao-Liang)

    2012-01-01

    textabstractAims: The impact of intravascular ultrasound (IVUS) guided coronary drug-eluting stent (DES) implantation on clinical outcomes remains controversial. A meta-analysis of the currently available clinical trials investi-gating IVUS-guided DES implantation was undertaken. Methods and

  6. Design of a randomized controlled trial to compare debridement to observation of chondral lesions encountered during partial meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial.

    Science.gov (United States)

    Bisson, Leslie J; Kluczynski, Melissa A; Wind, William M; Fineberg, Marc S; Bernas, Geoffrey A; Rauh, Michael A; Marzo, John M; Smolinski, Robert J

    2015-11-01

    Few studies have examined whether chondral lesions encountered in patients undergoing meniscectomy should be surgically treated. The primary aim of the ChAMP (Chondral Lesions And Meniscus Procedures) Trial is to determine whether there is a difference in knee pain between patients undergoing debridement versus observation of chondral lesions encountered during arthroscopic meniscectomy. This paper describes the rationale and study design for the ChAMP Trial. The ChAMP Trial is a randomized controlled trial of patients aged 30 and older undergoing partial meniscectomy and randomly allocated to debridement (CL-Deb, N=98) or observation (CL-Obs, N=92) of chondral lesions identified during surgery and deemed to be significant (Outerbridge Grade II-IV). Patients and data collectors were unaware of treatment allocation until completion of the study. Patients with surgically insignificant (Outerbridge Grade I) chondral lesions or no chondral lesions were included as a third non-randomized comparison group (NoCL, N=76). The primary outcome is the difference in knee pain assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) between the CL-Deb and CL-Obs groups at 1-year after surgery. Secondary outcomes include 1-year differences in additional measures of knee pain, function, symptoms, activity, and quality of life assessed by the WOMAC, KOOS (Knee Injury and Osteoarthritis Outcome Score), visual analog pain scale, and physical exam; as well as general health assessed with the SF-36 (Short-form Health Survey). Increased intraoperative costs associated with the addition of chondral debridement will also be assessed. This study will add to the scant literature regarding management of chondral lesions in patients undergoing meniscectomy and might provide treatment guidance for clinicians and their patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Observing Protein & Energy Nutrition (OPEN) Study

    Science.gov (United States)

    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.

  8. STRengthening analytical thinking for observational studies

    DEFF Research Database (Denmark)

    Sauerbrei, Willi; Abrahamowicz, Michal; Altman, Douglas G.

    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...

  9. Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study.

    Science.gov (United States)

    Roseman, Michelle; Turner, Erick H; Lexchin, Joel; Coyne, James C; Bero, Lisa A; Thombs, Brett D

    2012-08-16

    To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Cross sectional study. Cochrane Database of Systematic Reviews. Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews.

  10. Nonparametric estimation for censored mixture data with application to the Cooperative Huntington's Observational Research Trial.

    Science.gov (United States)

    Wang, Yuanjia; Garcia, Tanya P; Ma, Yanyuan

    2012-01-01

    This work presents methods for estimating genotype-specific distributions from genetic epidemiology studies where the event times are subject to right censoring, the genotypes are not directly observed, and the data arise from a mixture of scientifically meaningful subpopulations. Examples of such studies include kin-cohort studies and quantitative trait locus (QTL) studies. Current methods for analyzing censored mixture data include two types of nonparametric maximum likelihood estimators (NPMLEs) which do not make parametric assumptions on the genotype-specific density functions. Although both NPMLEs are commonly used, we show that one is inefficient and the other inconsistent. To overcome these deficiencies, we propose three classes of consistent nonparametric estimators which do not assume parametric density models and are easy to implement. They are based on the inverse probability weighting (IPW), augmented IPW (AIPW), and nonparametric imputation (IMP). The AIPW achieves the efficiency bound without additional modeling assumptions. Extensive simulation experiments demonstrate satisfactory performance of these estimators even when the data are heavily censored. We apply these estimators to the Cooperative Huntington's Observational Research Trial (COHORT), and provide age-specific estimates of the effect of mutation in the Huntington gene on mortality using a sample of family members. The close approximation of the estimated non-carrier survival rates to that of the U.S. population indicates small ascertainment bias in the COHORT family sample. Our analyses underscore an elevated risk of death in Huntington gene mutation carriers compared to non-carriers for a wide age range, and suggest that the mutation equally affects survival rates in both genders. The estimated survival rates are useful in genetic counseling for providing guidelines on interpreting the risk of death associated with a positive genetic testing, and in facilitating future subjects at risk

  11. The Alberta smoke plume observation study

    Science.gov (United States)

    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 datamart" target="_blank">http://cwfis.cfs.nrcan.gc.ca/datamart.

  12. The Alberta smoke plume observation study

    Directory of Open Access Journals (Sweden)

    K. Anderson

    2018-02-01

    Full Text Available 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.

  13. [The Strengthening the Reporting of Observational Studies in Epidemiology [STROBE] statement: guidelines for reporting observational studies

    DEFF Research Database (Denmark)

    Elm, E. von; Altman, D.G.; Egger, M.

    2008-01-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed rec...

  14. Exploring reasons for the observed inconsistent trial reports on intra-articular injections with hyaluronic acid in the treatment of osteoarthritis: Meta-regression analyses of randomized trials.

    Science.gov (United States)

    Johansen, Mette; Bahrt, Henriette; Altman, Roy D; Bartels, Else M; Juhl, Carsten B; Bliddal, Henning; Lund, Hans; Christensen, Robin

    2016-08-01

    The aim was to identify factors explaining inconsistent observations concerning the efficacy of intra-articular hyaluronic acid compared to intra-articular sham/control, or non-intervention control, in patients with symptomatic osteoarthritis, based on randomized clinical trials (RCTs). A systematic review and meta-regression analyses of available randomized trials were conducted. The outcome, pain, was assessed according to a pre-specified hierarchy of potentially available outcomes. Hedges׳s standardized mean difference [SMD (95% CI)] served as effect size. REstricted Maximum Likelihood (REML) mixed-effects models were used to combine study results, and heterogeneity was calculated and interpreted as Tau-squared and I-squared, respectively. Overall, 99 studies (14,804 patients) met the inclusion criteria: Of these, only 71 studies (72%), including 85 comparisons (11,216 patients), had adequate data available for inclusion in the primary meta-analysis. Overall, compared with placebo, intra-articular hyaluronic acid reduced pain with an effect size of -0.39 [-0.47 to -0.31; P hyaluronic acid. Based on available trial data, intra-articular hyaluronic acid showed a better effect than intra-articular saline on pain reduction in osteoarthritis. Publication bias and the risk of selective outcome reporting suggest only small clinical effect compared to saline. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Statistical challenges in observational cohort studies

    NARCIS (Netherlands)

    Hof, M.H.P.

    2015-01-01

    For over a century observational cohort studies have been used to study determinants of health and disease. Within a sample from the population, we can determine the relation between health outcomes (e.g. death) and a broad range of factors as genetic markers, environmental exposures, and lifestyle

  16. Physical fitness and mental health impact of a sport-for-development intervention in a post-conflict setting: randomised controlled trial nested within an observational study of adolescents in Gulu, Uganda.

    Science.gov (United States)

    Richards, Justin; Foster, Charlie; Townsend, Nick; Bauman, Adrian

    2014-06-18

    Physical inactivity contributes to poor fitness and mental health disorders. This is of concern in post-conflict low-income settings where non-communicable diseases are emerging and there is limited evidence for physical activity interventions. We examined the effects of a sport-for-development programme on adolescent physical fitness and mental health in Gulu, Uganda. We conducted a single-blinded RCT nested within an observational study with three unbalanced parallel groups. Participants were able-bodied adolescents aged 11-14 years. The intervention comprised an 11-week voluntary competitive sport-for-development football league. Participants who did not subscribe for the intervention formed a non-registered comparison group. Boys who registered for the sport-for-development programme were randomly allocated to the intervention or wait-listed. The girls programme subscription was insufficient to form a wait-list and all registrants received the intervention. Physical fitness was assessed by cardiorespiratory fitness (multi-stage fitness test), muscular power (standing broad jump) and body composition (BMI-for-age). Mental health was measured using the Acholi Psychosocial Assessment Instrument for local depression-like (DLS) and anxiety-like (ALS) syndromes. All randomisation was computer generated and assessors were masked to group allocation. An intention-to-treat analysis of adjusted effect size (ES) was applied. There were 1,462 adolescents in the study (intervention: boys = 74, girls = 81; wait-list: boys = 72; comparison: boys = 472, girls = 763). At four months follow-up there was no significant effect on the boys fitness when comparing intervention vs wait-listed and intervention vs non-registered groups. However, there was a negative effect on DLS when comparing boys intervention vs wait-listed (ES = 0.67 [0.33 to 1.00]) and intervention vs non-registered (ES = 0.25 [0.00 to 0.49]). Similar results were observed for ALS for boys intervention vs wait

  17. Upper limb children action-observation training (UP-CAT: a randomised controlled trial in Hemiplegic Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    Biagi Laura

    2011-06-01

    Full Text Available Abstract Background Rehabilitation for children with hemiplegic cerebral palsy (HCP aimed to improve function of the impaired upper limb (UL uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP. Methods/Design The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment, T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively. A further assessment will be performed at T3 (24 weeks after T1, to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2. Discussion The paper aims to

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

    Science.gov (United States)

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

    2014-01-01

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

  19. New analysis tools for observational studies

    NARCIS (Netherlands)

    Landewé, R. B. M.

    2015-01-01

    Observational studies, which are very common in rheumatology, usually follow a selected group of patients for a predetermined period of time, or infinitely, with regard to a certain outcome. Such an outcome could be a "score" reflecting an important aspect of the disease (e.g., a disease activity

  20. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  1. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies

    OpenAIRE

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2014-01-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study’s generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-contro...

  2. Ozone Lidar Observations for Air Quality Studies

    Science.gov (United States)

    Wang, Lihua; Newchurch, Mike; Kuang, Shi; Burris, John F.; Huang, Guanyu; Pour-Biazar, Arastoo; Koshak, William; Follette-Cook, Melanie B.; Pickering, Kenneth E.; McGee, Thomas J.; hide

    2015-01-01

    Tropospheric ozone lidars are well suited to measuring the high spatio-temporal variability of this important trace gas. Furthermore, lidar measurements in conjunction with balloon soundings, aircraft, and satellite observations provide substantial information about a variety of atmospheric chemical and physical processes. Examples of processes elucidated by ozone-lidar measurements are presented, and modeling studies using WRF-Chem, RAQMS, and DALES/LES models illustrate our current understanding and shortcomings of these processes.

  3. Disagreements in meta-analyses using outcomes measured on continuous or rating scales: observer agreement study

    DEFF Research Database (Denmark)

    Tendal, Britta; Higgins, Julian P T; Jüni, Peter

    2009-01-01

    OBJECTIVE: To study the inter-observer variation related to extraction of continuous and numerical rating scale data from trial reports for use in meta-analyses. DESIGN: Observer agreement study. DATA SOURCES: A random sample of 10 Cochrane reviews that presented a result as a standardised mean...

  4. A prospective observational trial on emesis in radiotherapy: Analysis of 1020 patients recruited in 45 Italian radiation oncology centres

    International Nuclear Information System (INIS)

    Maranzano, Ernesto; De Angelis, Verena; Pergolizzi, Stefano; Lupattelli, Marco; Frata, Paolo; Spagnesi, Stefano; Frisio, Maria Luisa; Mandoliti, Giovanni; Malinverni, Giuseppe; Trippa, Fabio; Fabbietti, Letizia; Parisi, Salvatore; Di Palma, Annamaria; De Vecchi, Pietro; De Renzis, Costantino; Giorgetti, Celestino; Bergami, Tiziano; Orecchia, Roberto; Portaluri, Maurizio; Signor, Marco

    2010-01-01

    Purpose: A prospective observational multicentre trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and to evaluate the use of antiemetic drugs in patients treated with radiotherapy or concomitant radio-chemotherapy. The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied. Materials and methods: Forty-five Italian radiation oncology centres took part in this trial. The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled. Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it. Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions. Results: A total of 1020 patients entered into the trial, and 1004 were evaluable. Vomiting and nausea occurred in 11.0% and 27.1% of patients, respectively, and 27.9% patients had both vomiting and nausea. In multifactorial analysis, the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy. Moreover, two radiotherapy-related factors were significant risk factors for RIE, the irradiated site (upper abdomen) and field size (>400 cm 2 ). An antiemetic drug was given only to a minority (17%) of patients receiving RT, and the prescriptions were prophylactic in 12.4% and symptomatic in 4.6%. Different compounds and a wide range of doses and schedules were used. Conclusions: These data were similar to those registered in our previous observational trial, and the radiation oncologists' attitude in underestimating RIE and under prescribing antiemetics was confirmed.

  5. The NOAA Satellite Observing System Architecture Study

    Science.gov (United States)

    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.

  6. Folic Acid Supplementation and Preterm Birth: Results from Observational Studies

    Directory of Open Access Journals (Sweden)

    Elena Mantovani

    2014-01-01

    Full Text Available Introduction. Folic acid (FA supplementation is recommended worldwide in the periconceptional period for the prevention of neural tube defects. Due to its involvement in a number of cellular processes, its role in other pregnancy outcomes such as miscarriage, recurrent miscarriage, low birth weight, preterm birth (PTB, preeclampsia, abruptio placentae, and stillbirth has been investigated. PTB is a leading cause of perinatal mortality and morbidity; therefore its association with FA supplementation is of major interest. The analysis of a small number of randomized clinical trials (RCTs has not found a beneficial role of FA in reducing the rate of PTBs. Aim of the Study. The aim of this review was to examine the results from recent observational studies about the effect of FA supplementation on PTB. Materials and Methods. We carried out a search on Medline and by manual search of the observational studies from 2009 onwards that analyzed the rate of PTB in patients who received supplementation with FA before and/or throughout pregnancy. Results. The results from recent observational studies suggest a slight reduction of PTBs that is not consistent with the results from RCTs. Further research is needed to better understand the role of FA supplementation before and during pregnancy in PTB.

  7. The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders

    OpenAIRE

    Jakubovski, Ewgeni; Reichert, Cornelia; Karch, Annika; Buddensiek, Nadine; Breuer, Daniel; M?ller-Vahl, Kirsten

    2016-01-01

    Background In recent years, behavioral therapy with comprehensive behavioral intervention for tics (CBIT) has been recognized as an effective and safe treatment in patients with Gilles de la Tourette syndrome. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated Internet-delivered CBIT (iCBIT) program. With this study, we want to demonstrate th...

  8. Recruitment barriers for prophylactic vaccine trials: A study in Belgium.

    Science.gov (United States)

    Harrington, Lauriane; Van Damme, Pierre; Vandermeulen, Corinne; Mali, Stéphanie

    2017-12-04

    Recruitment of volunteers is one of the main challenges in clinical trial management, and there is little information about recruitment barriers for preventative vaccine trials. We investigated both the recruitment barriers and recruitment strategies for preventive vaccine trials in Belgium. A 10 min survey was used as well as interviews of staff at all clinical trial sites in Belgium that regularly perform vaccine trials. We observed that there are successful recruitment strategies and few recruitment issues for trials involving healthy adults and those over 65 years old. However, challenges face the recruitment of paediatric populations, pregnant women, patients and the very elderly (over 85 years old). From these results, we identified three priority areas to increase recruitment for prophylactic vaccine trials in Belgium. These are: the lack of public knowledge about infectious diseases; the lack of resources of healthcare professionals to take part in clinical trials; and the burden to potential volunteers to take part in a trial. These were discussed with stakeholders and solutions were proposed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn

    2008-01-01

    Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT...... essentially unchanged and in the case of all cause mortality, the risk reduction of 15% now achieved borderline statistical significance (P = 0.02). Conclusion Carry-over benefits from those originally assigned atorvastatin but no longer taking the drug may account for unchanged relative risk reductions...

  10. Folic acid supplementation and preterm birth: results from observational studies.

    Science.gov (United States)

    Mantovani, Elena; Filippini, Francesca; Bortolus, Renata; Franchi, Massimo

    2014-01-01

    Folic acid (FA) supplementation is recommended worldwide in the periconceptional period for the prevention of neural tube defects. Due to its involvement in a number of cellular processes, its role in other pregnancy outcomes such as miscarriage, recurrent miscarriage, low birth weight, preterm birth (PTB), preeclampsia, abruptio placentae, and stillbirth has been investigated. PTB is a leading cause of perinatal mortality and morbidity; therefore its association with FA supplementation is of major interest. The analysis of a small number of randomized clinical trials (RCTs) has not found a beneficial role of FA in reducing the rate of PTBs. The aim of this review was to examine the results from recent observational studies about the effect of FA supplementation on PTB. We carried out a search on Medline and by manual search of the observational studies from 2009 onwards that analyzed the rate of PTB in patients who received supplementation with FA before and/or throughout pregnancy. The results from recent observational studies suggest a slight reduction of PTBs that is not consistent with the results from RCTs. Further research is needed to better understand the role of FA supplementation before and during pregnancy in PTB.

  11. Sequence analysis to assess labour market participation following vocational rehabilitation: an observational study among patients sick-listed with low back pain from a randomised clinical trial in Denmark.

    Science.gov (United States)

    Lindholdt, Louise; Labriola, Merete; Nielsen, Claus Vinther; Horsbøl, Trine Allerslev; Lund, Thomas

    2017-07-20

    The return-to-work (RTW) process after long-term sickness absence is often complex and long and implies multiple shifts between different labour market states for the absentee. Standard methods for examining RTW research typically rely on the analysis of one outcome measure at a time, which will not capture the many possible states and transitions the absentee can go through. The purpose of this study was to explore the potential added value of sequence analysis in supplement to standard regression analysis of a multidisciplinary RTW intervention among patients with low back pain (LBP). The study population consisted of 160 patients randomly allocated to either a hospital-based brief or a multidisciplinary intervention. Data on labour market participation following intervention were obtained from a national register and analysed in two ways: as a binary outcome expressed as active or passive relief at a 1-year follow-up and as four different categories for labour market participation. Logistic regression and sequence analysis were performed. The logistic regression analysis showed no difference in labour market participation for patients in the two groups after 1 year. Applying sequence analysis showed differences in subsequent labour market participation after 2 years after baseline in favour of the brief intervention group versus the multidisciplinary intervention group. The study indicated that sequence analysis could provide added analytical value as a supplement to traditional regression analysis in prospective studies of RTW among patients with LBP. © 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.

  12. What is the appropriate duration of a therapeutic trial in cutaneous tuberculosis? Further observations

    Directory of Open Access Journals (Sweden)

    Ramam M

    2007-01-01

    Full Text Available Background: Laboratory tests for the diagnosis of cutaneous tuberculosis lack adequate sensitivity and specificity and a trial of therapy is often used as a diagnostic test in difficult cases. However, the duration for which the trial should be undertaken is not clearly defined. Our previous study indicated that one month of therapy was adequate to detect a clinical response to treatment. However, about half the patients first reported after one month of treatment, some much later. Method: We therefore analysed the treatment records of 107 patients who received four-drug, short course, antitubercular therapy for a diagnosis of cutaneous tuberculosis in our hospital and who were asked to return for follow-up at biweekly intervals in the first month of treatment. Result: Twenty-one patients did not return for any follow-up visit, nine patients did not respond to treatment and treatment was stopped in one patient. Of the remaining 76 patients, 72 patients were recorded to have distinct clinical improvement within five weeks of starting treatment while only four patients showed improvement after 60-123 (8-17 weeks days of therapy. Conclusion: These findings indicate that five weeks appears to be an adequate duration of a therapeutic trial in patients suspected to have cutaneous tuberculosis, with the exception of tuberculids and patients showing minimal clinical activity before treatment. Patients who have not responded by this time are unlikely to do so with further treatment and should have their diagnosis reviewed.

  13. Globular Cluster Tidal Streams: An Observational Study

    Science.gov (United States)

    Powell, William L.; Lauchner, A.; Wilhelm, R.; McWilliam, A.

    2006-12-01

    Globular cluster tidal streams are of interest for what they can tell us of the dynamical evolution of the clusters and of our Galaxy. Recent studies have used photometric and statistical subtraction methods to attempt to separate potential streams from the field stars that contaminate the samples. We chose instead as our primary method to use photometry to select blue stars that match the horizontal branch of the clusters. We then make spectroscopic observations of these candidates to determine their metallicity and radial velocities. Combining these results with the photometric data offers a better picture of the structure and validity of tidal streams. We present photometric and spectroscopic results for several globular clusters and their surrounding fields. Data were obtained at McDonald Observatory, Kitt Peak, and Las Campanas Observatory. SDSS data were also used. WLP acknowledges the support of a Sigma Xi Grant-In-Aid of research. RW acknowledges the support of a AAS Small Research Grant.

  14. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies

    OpenAIRE

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2007-01-01

    Poor reporting of research hampers assessment and makes it less useful. An international group of methodologists, researchers, and journal editors sets out guidelines to improve reports of observational studies

  15. Atrial fibrillation: an observational study with outpatients.

    Science.gov (United States)

    Albina, Gastón; De Luca, Julián; Conde, Diego; Giniger, Alberto

    2014-11-01

    Atrial fibrillation (AF) is the most common sustained arrhythmia with serious clinical consequences in the absence of treatment. However, there are limited data on the treatment of these patients in Argentina. The objective was to describe the therapeutic management of patients with nonacute AF by Argentinean cardiologists and to determine the incidence of clinical events after 12 months follow-up. The Atrial Fibrillation study in Argentina (FARAON) was an observational, descriptive, prospective, national, and multicentric study that included outpatients with AF, followed for 12 months. The study included 38 sites in Argentina. Each researcher included the first 10 patients who met the inclusion criteria of being over 21 and also being an AF carrier documented by electrocardiogram or Holter within 12 months prior to or at the time of enrollment. A total of 373 patients were included, mean age 70 ± 11.5 years, 40% women; 65% had AF rhythm at the time of inclusion, 57% had permanent AF, and 56% were asymptomatic. At the time of enrollment, 40% of physicians opted for rhythm control strategy. β-blockers and amiodarone were the most used drugs. Patients with rhythm control drugs had higher success rate than those with frequency control drug therapy (80% vs 57%). Cardiologists in Argentina receive patients with AF that are mostly permanent AF. More than half of the patients are asymptomatic. They opt primarily by controlling the pace. When choosing antiarrhythmic drugs, nearly half of them indicated amiodarone. © 2014 Wiley Periodicals, Inc.

  16. Early diphtheria-tetanus-pertussis vaccination associated with higher female mortality and no difference in male mortality in a cohort of low birthweight children: an observational study within a randomised trial.

    Science.gov (United States)

    Aaby, Peter; Ravn, Henrik; Roth, Adam; Rodrigues, Amabelia; Lisse, Ida Maria; Diness, Birgitte Rode; Lausch, Karen Rokkedal; Lund, Najaaraq; Rasmussen, Julie; Biering-Sørensen, Sofie; Whittle, Hilton; Benn, Christine Stabell

    2012-08-01

    Studies from low-income countries have suggested that diphtheria-tetanus-pertussis (DTP) vaccine provided after Bacille Calmette-Guerin (BCG) vaccination may have a negative effect on female survival. The authors examined the effect of DTP in a cohort of low birthweight (LBW) infants. 2320 LBW newborns were visited at 2, 6 and 12 months of age to assess nutritional and vaccination status. The authors examined survival until the 6-month visit for children who were DTP vaccinated and DTP unvaccinated at the 2-month visit. Two-thirds of the children had received DTP at 2 months and 50 deaths occurred between the 2-month and 6-month visits. DTP vaccinated children had a better anthropometric status for all indices than DTP unvaccinated children. Small mid-upper arm circumference (MUAC) was the strongest predictor of mortality. The death rate ratio (DRR) for DTP vaccinated versus DTP unvaccinated children differed significantly for girls (DRR 2.45; 95% CI 0.93 to 6.45) and boys (DRR 0.53; 95% CI 0.23 to 1.20) (p=0.018, homogeneity test). Adjusting for MUAC, the overall effect for DTP vaccinated children was 2.62 (95% CI 1.34 to 5.09); DRR was 5.68 (95% CI 1.83 to 17.7) for girls and 1.29 (95% CI 0.56 to 2.97) for boys (p=0.023, homogeneity test). While anthropometric indices were a strong predictor of mortality among boys, there was little or no association for girls. Surprisingly, even though the children with the best nutritional status were vaccinated early, early DTP vaccination was associated with increased mortality for girls.

  17. Low-Density Lipoprotein Cholesterol Lowering for the Primary Prevention of Cardiovascular Disease Among Men With Primary Elevations of Low-Density Lipoprotein Cholesterol Levels of 190 mg/dL or Above: Analyses From the WOSCOPS (West of Scotland Coronary Prevention Study) 5-Year Randomized Trial and 20-Year Observational Follow-Up.

    Science.gov (United States)

    Vallejo-Vaz, Antonio J; Robertson, Michele; Catapano, Alberico L; Watts, Gerald F; Kastelein, John J; Packard, Chris J; Ford, Ian; Ray, Kausik K

    2017-11-14

    Patients with primary elevations of low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL are at a higher risk of atherosclerotic cardiovascular disease as a result of long-term exposure to markedly elevated LDL-C levels. Therefore, initiation of statin therapy is recommended for these individuals. However, there is a lack of randomized trial evidence supporting these recommendations in primary prevention. In the present analysis, we provide hitherto unpublished data on the cardiovascular effects of LDL-C lowering among a primary prevention population with LDL-C ≥190 mg/dL. We aimed to assess the benefits of LDL-C lowering on cardiovascular outcomes among individuals with primary elevations of LDL-C ≥190 mg/dL without preexisting vascular disease at baseline. We performed post hoc analyses from the WOSCOPS (West of Scotland Coronary Prevention Study) randomized, placebo-controlled trial, and observational posttrial long-term follow-up, after excluding individuals with evidence of vascular disease at baseline. WOSCOPS enrolled 6595 men aged 45 to 64 years, who were randomly assigned to pravastatin 40 mg/d or placebo. In the present analyses, 5529 participants without evidence of vascular disease were included, stratified by LDL-C levels into those with LDL-C coronary heart disease and major adverse cardiovascular events were assessed over the 4.9-year randomized controlled trial phase and on mortality outcomes over a total of 20 years of follow-up. Among 5529 individuals without vascular disease, pravastatin reduced the risk of coronary heart disease by 27% ( P =0.002) and major adverse cardiovascular events by 25% ( P =0.004) consistently among those with and without LDL-C ≥190 mg/dL ( P -interaction >0.9). Among individuals with LDL-C ≥190 mg/dL, pravastatin reduced the risk of coronary heart disease by 27% ( P =0.033) and major adverse cardiovascular events by 25% ( P =0.037) during the initial trial phase and the risk of coronary heart disease death

  18. Fasting with diabetes: a prospective observational study

    Science.gov (United States)

    Noon, Muhammad Jawad; Khawaja, Haseeb Ahmad; Ishtiaq, Osama; Khawaja, Quratulain; Minhas, Sana; Niazi, Asfandyar Khan; Minhas, Abdul Mannan Khan; Malhi, Umar Rasool

    2016-01-01

    Objectives To determine the proportion of diabetic patients who develop adverse glycaemic events when fasting regularly. Design Prospective observational study conducted at a tertiary care hospital in South Asia. Five hundred and twenty-three patients were assessed for eligibility, and 150 were included in the final analysis. Diabetic patients over 18 years of age who were willing to fast regularly and make a chart of their daily blood sugar levels were included in the study. The main outcome measures were hypoglycaemic and hyperglycaemic events. Frequencies and percentages were calculated for quantitative variables, while mean±SD were documented for qualitative variables. Relative risk was calculated as a measure of association. Results Of a total of 150 individuals, 10% experienced hypoglycaemia, while 3.3% reported hyperglycaemic episodes. Only 8.7% of the participants discontinued one or more fasts; however, none of them required hospitalisation. There is a negative association between a visit to a physician by diabetic patients before they begin to fast regularly and the risk of developing hypoglycaemia (relative risk 0.73). Conclusions Many diabetic patients who fast regularly are at high risk of adverse glycaemic events. Most diabetics do not consult their physicians before fasting to adjust medications and lifestyle. Various strategies should be planned and implemented for the awareness and education of such patients to avoid adverse glycaemic events and subsequent complications. PMID:28588932

  19. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    BACKGROUND: A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. OBJECTIVES......: The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...... of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. TRIAL REGISTRATION: ClinicalTrials.gov NCT00484302....

  20. [The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies].

    Science.gov (United States)

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2008-01-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies.

  1. [The Strengthening the Reporting of Observational Studies in Epidemiology [STROBE] statement: guidelines for reporting observational studies].

    Science.gov (United States)

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2008-01-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a che-cklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies.

  2. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

    Science.gov (United States)

    von Elm, Erik; Altman, Douglas G; Egger, Matthias; Pocock, Stuart J; Gøtzsche, Peter C; Vandenbroucke, Jan P

    2014-12-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE statement: guidelines for reporting observational studies.

    Directory of Open Access Journals (Sweden)

    Erik von Elm

    2007-10-01

    Full Text Available Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

  4. Observed and predicted reduction of ischemic cardiovascular events in the Simvastatin and Ezetimibe in Aortic Stenosis trial

    DEFF Research Database (Denmark)

    Holme, Ingar; Boman, Kurt; Brudi, Philippe

    2010-01-01

    In the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, combined ezetimibe (10 mg) and simvastatin (40 mg) decreased low-density lipoprotein cholesterol levels by 50% and ischemic cardiovascular event (ICE) risk by 22% compared to placebo. A larger decrease in ICE risk might have been...... expected for the degree of lipid-lowering observed. This analysis investigated relations between changes in lipoprotein components (LCs), and ICE risk decrease in the SEAS trial in all patients, by severity of aortic stenosis (AS), and compared to results of other clinical trials. A total of 1,570 patients...

  5. Multicenter observational prehospital resuscitation on helicopter study.

    Science.gov (United States)

    Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

    2017-07-01

    Earlier use of in-hospital plasma, platelets, and red blood cells (RBCs) has improved survival in trauma patients with severe hemorrhage. Retrospective studies have associated improved early survival with prehospital blood product transfusion (PHT). We hypothesized that PHT of plasma and/or RBCs would result in improved survival after injury in patients transported by helicopter. Adult trauma patients transported by helicopter from the scene to nine Level 1 trauma centers were prospectively observed from January to November 2015. Five helicopter systems had plasma and/or RBCs, whereas the other four helicopter systems used only crystalloid resuscitation. All patients meeting predetermined high-risk criteria were analyzed. Patients receiving PHT were compared with patients not receiving PHT. Our primary analysis compared mortality at 3 hours, 24 hours, and 30 days, using logistic regression to adjust for confounders and site heterogeneity to model patients who were matched on propensity scores. Twenty-five thousand one hundred eighteen trauma patients were admitted, 2,341 (9%) were transported by helicopter, of which 1,058 (45%) met the highest-risk criteria. Five hundred eighty-five of 1,058 patients were flown on helicopters carrying blood products. In the systems with blood available, prehospital median systolic blood pressure (125 vs 128) and Glasgow Coma Scale (7 vs 14) was significantly lower, whereas median Injury Severity Score was significantly higher (21 vs 14). Unadjusted mortality was significantly higher in the systems with blood products available, at 3 hours (8.4% vs 3.6%), 24 hours (12.6% vs 8.9%), and 30 days (19.3% vs 13.3%). Twenty-four percent of eligible patients received a PHT. A median of 1 unit of RBCs and plasma were transfused prehospital. Of patients receiving PHT, 24% received only plasma, 7% received only RBCs, and 69% received both. In the propensity score matching analysis (n = 109), PHT was not significantly associated with mortality

  6. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  7. Century Scale Evaporation Trend: An Observational Study

    Science.gov (United States)

    Bounoui, Lahouari

    2012-01-01

    Several climate models with different complexity indicate that under increased CO2 forcing, runoff would increase faster than precipitation overland. However, observations over large U.S watersheds indicate otherwise. This inconsistency between models and observations suggests that there may be important feedbacks between climate and land surface unaccounted for in the present generation of models. We have analyzed century-scale observed annual runoff and precipitation time-series over several United States Geological Survey hydrological units covering large forested regions of the Eastern United States not affected by irrigation. Both time-series exhibit a positive long-term trend; however, in contrast to model results, these historic data records show that the rate of precipitation increases at roughly double the rate of runoff increase. We considered several hydrological processes to close the water budget and found that none of these processes acting alone could account for the total water excess generated by the observed difference between precipitation and runoff. We conclude that evaporation has increased over the period of observations and show that the increasing trend in precipitation minus runoff is correlated to observed increase in vegetation density based on the longest available global satellite record. The increase in vegetation density has important implications for climate; it slows but does not alleviate the projected warming associated with greenhouse gases emission.

  8. Acyclovir in pityriasis rosea: An observer-blind, randomized controlled trial of effectiveness, safety and tolerability

    Directory of Open Access Journals (Sweden)

    Anupam Das

    2015-01-01

    Full Text Available Background: Pityriasis rosea (PR is an acute inflammatory dermatosis. The association of human herpes virus 6 and 7 suggests the utility of use of antiviral agents in this disease. Aims and Objectives: To evaluate the effectiveness and safety of acyclovir in the treatment of PR. Methods: An observer-blind, randomized (1:1, parallel group, add-on trial was conducted on 24 adult patients with PR. Subjects of both Group A and B received the standard of care in the form of cetirizine 10 mg OD and calamine. Group A in addition received acyclovir 400 mg tablets thrice daily for 7 days. Both groups were followed up for four consecutive weeks for assessment of effectiveness and adverse events. Results: Group A complained of significantly fewer new lesions than Group B (P = 0.046. A complete response was obtained in all patients of Group A and 83% patients of Group B at the end of the follow up period. There was significant reduction in both lesional score and pruritus at second week follow-up in Group A and third week follow-up in Group B (P < 0.05. Minor adverse effects were observed in both treatment arms. Conclusion: Acyclovir offered rapid resolution of clinical severity of PR from second week onwards without significantly increased adverse events as compared to supportive therapy alone.

  9. Mirror therapy in children with hemiparesis: a randomized observer-blinded trial.

    Science.gov (United States)

    Bruchez, Roselyn; Jequier Gygax, Marine; Roches, Sylvie; Fluss, Joel; Jacquier, David; Ballabeni, Pierluigi; Grunt, Sebastian; Newman, Christopher J

    2016-09-01

    To determine the efficacy of mirror therapy in children with hemiparesis. The design was an observer-blinded parallel-group randomized controlled trial (International Standard Randomised Controlled Trial Number 48748291). Randomization was computer-generated, 1:1 allocation to mirror therapy or comparison groups. The settings were home-based intervention and tertiary centre assessments. Participants were 90 children with hemiparesis aged 7 to 17 years. Intervention was 15 minutes per day of simultaneous arm training, 5 days a week, for 5 weeks. The mirror therapy group used a mirror; those in the comparison group looked at their paretic limb. Assessments comprised measures of upper limb strength, function (Melbourne Assessment 2), daily performance (ABILHAND-Kids), and sensory function at weeks 0 (T0 ), 5 (T1 ), and 10 (T2 ). There were no significant differences in outcomes and their progression over time between the mirror therapy and comparison groups. Post-hoc intention-to-treat analyses showed significant improvements in both groups for grasp strength (T0 -T1 +12.6%), pinch strength (T0 -T2 +9.1%), upper limb function in terms of accuracy (T0 -T2 +2.7%) and fluency (T0 -T2 +5.0%), as well as daily performance (T0 -T2 +16.6%). Per protocol analyses showed additional improvements in dexterity (T0 -T2 +4.0%). The use of the mirror illusion during therapy had no significant effect on treatment outcomes. However, 5 weeks of daily simultaneous arm training significantly improved paretic upper limb strength, function, and daily use. © 2016 Mac Keith Press.

  10. Sensitivity of dose-finding studies to observation errors.

    Science.gov (United States)

    Zohar, Sarah; O'Quigley, John

    2009-11-01

    The purpose of Phase I designs is to estimate the MTD (maximum tolerated dose, in practice a dose with some given acceptable rate of toxicity) while, at the same time, minimizing the number of patients treated at doses too far removed from the MTD. Our purpose here is to investigate the sensitivity of conclusions from dose-finding designs to recording or observation errors. Certain toxicities may go undetected and, conversely, certain non-toxicities may be incorrectly recorded as dose-limiting toxicities. Recording inaccuracies would be expected to have an influence on final and within trial recommendations and, in this paper, we study in greater depth this question. We focus, in particular on three designs used currently; the standard '3+3' design, the grouped up-and-down design [M. Gezmu, N. Flournoy, Group up-and-down designs for dose finding. Journal of Statistical Planning and Inference 2006; 136 (6): 1749-1764.] and the continual reassessment method (CRM, [J. O'Quigley, M. Pepe, L. Fisher, Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990; 46 (1): 33-48.]). A non-toxicity incorrectly recorded as a toxicity (error of first kind) has a greater influence in general than the converse (error of second kind). These results are illustrated via figures which suggest that the standard '3+3' design in particular is sensitive to errors of the second kind. Such errors can have a very important impact on drug development in that, if carried through to the Phase 2 and Phase 3 studies, we can significantly increase the probability of failure to detect efficacy as a result of having delivered an inadequate dose.

  11. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  12. Comparing CISNET Breast Cancer Incidence and Mortality Predictions to Observed Clinical Trial Results of Mammography Screening from Ages 40 to 49.

    Science.gov (United States)

    van den Broek, Jeroen J; van Ravesteyn, Nicolien T; Mandelblatt, Jeanne S; Huang, Hui; Ergun, Mehmet Ali; Burnside, Elizabeth S; Xu, Cong; Li, Yisheng; Alagoz, Oguzhan; Lee, Sandra J; Stout, Natasha K; Song, Juhee; Trentham-Dietz, Amy; Plevritis, Sylvia K; Moss, Sue M; de Koning, Harry J

    2018-04-01

    The UK Age trial compared annual mammography screening of women ages 40 to 49 years with no screening and found a statistically significant breast cancer mortality reduction at the 10-year follow-up but not at the 17-year follow-up. The objective of this study was to compare the observed Age trial results with the Cancer Intervention and Surveillance Modeling Network (CISNET) breast cancer model predicted results. Five established CISNET breast cancer models used data on population demographics, screening attendance, and mammography performance from the Age trial together with extant natural history parameters to project breast cancer incidence and mortality in the control and intervention arm of the trial. The models closely reproduced the effect of annual screening from ages 40 to 49 years on breast cancer incidence. Restricted to breast cancer deaths originating from cancers diagnosed during the intervention phase, the models estimated an average 15% (range across models, 13% to 17%) breast cancer mortality reduction at the 10-year follow-up compared with 25% (95% CI, 3% to 42%) observed in the trial. At the 17-year follow-up, the models predicted 13% (range, 10% to 17%) reduction in breast cancer mortality compared with the non-significant 12% (95% CI, -4% to 26%) in the trial. The models underestimated the effect of screening on breast cancer mortality at the 10-year follow-up. Overall, the models captured the observed long-term effect of screening from age 40 to 49 years on breast cancer incidence and mortality in the UK Age trial, suggesting that the model structures, input parameters, and assumptions about breast cancer natural history are reasonable for estimating the impact of screening on mortality in this age group.

  13. Yogurt and Diabetes: Overview of Recent Observational Studies.

    Science.gov (United States)

    Salas-Salvadó, Jordi; Guasch-Ferré, Marta; Díaz-López, Andrés; Babio, Nancy

    2017-07-01

    The effects of dairy consumption on the prevention of type 2 diabetes remain controversial and depend on the dairy subtype. Yogurt intake has received special attention because its association with health benefits is more consistent than that of other types of dairy products. In the present article, we review those observational studies that evaluated the association between yogurt consumption and type 2 diabetes. We also discuss the possible mechanisms involved in these associations. We found that 13 prospective studies evaluated the association between yogurt intake and type 2 diabetes, most of which showed an inverse association between the frequency of yogurt consumption and the risk of diabetes. In addition to the scientific evidence accumulated from individual prospective studies, several meta-analyses have shown that yogurt consumption has a potential role in diabetes prevention. The most recent analysis shows a 14% lower risk of type 2 diabetes when yogurt consumption was 80-125 g/d compared with no yogurt consumption. The intake of fermented dairy products, especially yogurt, has been inversely associated with variables of glucose metabolism. Yogurt may have probiotic effects that could modulate glucose metabolism. We conclude that yogurt consumption, in the context of a healthy dietary pattern, may reduce the risk of type 2 diabetes in healthy and older adults at high cardiovascular risk. Large-scale intervention studies and randomized clinical trials are warranted to determine if yogurt consumption has beneficial effects on insulin sensitivity and reduces the risk of type 2 diabetes. © 2017 American Society for Nutrition.

  14. [The Strengthening the Reporting of Observational Studies in Epidemiology [STROBE] statement: guidelines for reporting observational studies

    DEFF Research Database (Denmark)

    Elm, E. von; Altman, D.G.; Egger, M.

    2008-01-01

    Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed......, researchers, and journal editors to draft a che-cklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop...... and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case...

  15. Geomagnetic Observations for Main Field Studies

    DEFF Research Database (Denmark)

    Matzka, Jürgen; Chulliat, A.; Mandea, M.

    2010-01-01

    and the beginning of geomagnetic repeat stations surveys in the 19th century. In the second half of the 20th century, true global coverage with geomagnetic field measurements was accomplished by magnetometer payloads on low-Earth-orbiting satellites. This article describes the procedures and instruments...... for magnetic field measurements on ground and in space and covers geomagnetic observatories, repeat stations, automatic observatories, satellites and historic observations. Special emphasis is laid on the global network of geomagnetic observatories....

  16. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.

    Science.gov (United States)

    Ivers, N M; Taljaard, M; Dixon, S; Bennett, C; McRae, A; Taleban, J; Skea, Z; Brehaut, J C; Boruch, R F; Eccles, M P; Grimshaw, J M; Weijer, C; Zwarenstein, M; Donner, A

    2011-09-26

    To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are

  17. Measurement Error Correction Formula for Cluster-Level Group Differences in Cluster Randomized and Observational Studies

    Science.gov (United States)

    Cho, Sun-Joo; Preacher, Kristopher J.

    2016-01-01

    Multilevel modeling (MLM) is frequently used to detect cluster-level group differences in cluster randomized trial and observational studies. Group differences on the outcomes (posttest scores) are detected by controlling for the covariate (pretest scores) as a proxy variable for unobserved factors that predict future attributes. The pretest and…

  18. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  19. 'Beyond Milestones': a randomised controlled trial evaluating an innovative digital resource teaching quality observation of normal child development.

    Science.gov (United States)

    Connolly, Anne M; Cunningham, Clare; Sinclair, Adriane J; Rao, Arjun; Lonergan, Amy; Bye, Ann M E

    2014-05-01

    The study aimed to create and evaluate the educational effectiveness of a digital resource instructing paediatric trainees in a systematic approach to critical and quality observation of normal child development. A digital educational resource was developed utilising the skills of an expert developmental paediatrician who was videoed assessing normal early child development at a series of critical stages. Videos illustrated aspects of language, sophistication of play and socialisation, cognition, and motor progress. Expert commentary, teaching text and summaries were used. A randomised controlled trial evaluated the resource. Paediatric trainees were recruited from The Sydney Children's Hospitals Network. Outcome measures were repeated at three time points (pre-teaching, immediate-post and 1 month) and included self-rated attitudes, knowledge of markers of development and observational expertise. Qualitative data on teaching usefulness were obtained through open-ended questions. Fifty-six paediatric trainees (registrar 79%, women 82%; mean age 31 years) completed the pre-assessment, 46 the immediate-post and 45 the 1-month follow-up (20% attrition). Compared with the Control group, the Teaching group scored higher over time on markers of development (P = 0.006), observational expertise (P improves knowledge, increases confidence and is useful, providing a structured approach to developmental assessment. The techniques taught can be applied to every paediatric consultation. © 2013 The Authors. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  20. Fibrin glue versus sutures for attaching the conjunctival autograft in pterygium surgery: a prospective observer masked clinical trial.

    Science.gov (United States)

    Srinivasan, S; Dollin, M; McAllum, P; Berger, Y; Rootman, D S; Slomovic, A R

    2009-02-01

    To compare the degree of conjunctival autograft inflammation, subconjunctival haemorrhage (SCH) and graft stability following the use of sutures or fibrin glue (FG) during pterygium surgery. Prospective, observer masked, clinical trial. 40 eyes of 40 patients undergoing primary pterygium surgery with conjunctival autograft were allocated into two groups. Group 1 (n = 20) had FG (Tisseel) for attaching the conjunctival autograft, whereas group 2 (n = 20) had sutures. Standardised digital slit-lamp photographs were taken at 1 week, 1 month and 3 months postoperatively. Sutures were masked using commercially available photo-editing software. Two masked observers objectively graded the digital photographs for degree of inflammation, SCH and graft stability. 34 of the 40 patients completed the study. When using FG, the degree of inflammation was significantly less than with sutures at 1 month (p = 0.019) and 3 months (p = 0.001) postoperatively. No significant difference was found for inflammation at 1 week postoperatively (p = 0.518). Conjunctival grafts secured with FG were as stable as those secured with sutures (p = 0.258, p = 0.076 and p = 0.624, at 1 week, 1 month and 3 months, respectively). No significant difference was found in degree of postoperative SCH between the groups (p = 0.417, p = 1 and p = 1, at 1 week, 1 month and 3 months, respectively). This is the first prospective clinical trial confirming that conjunctival grafts secured with FG during pterygium surgery not only are as stable as those secured with sutures, but also produce significantly less inflammation.

  1. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 4: observational studies.

    Science.gov (United States)

    Manchikanti, Laxmaiah; Singh, Vijay; Smith, Howard S; Hirsch, Joshua A

    2009-01-01

    Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigms, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. There is competition, contrast, and a feeling of inferiority and uselessness for observational studies, created by a lack of understanding of medical research. However, observational studies and randomized clinical trials (RCTs) can be viewed as the steps of observation and experimentation that form the basis of the scientific methodology. Further, rational healthcare practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis, and treatment of disorders. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, design, implementation, and reporting of observational studies is crucial. The biased interpretation of results from observational studies, either in favor of or opposed to a treatment, and lack of proper understanding of observational studies, leads to a poor appraisal of the quality. Similar to the Consolidated Standards of Reporting Trials (CONSORT) statement for the reporting of randomized trials, the Strengthening of the Reporting of Observational Studies in Epidemiology (STROBE) statement was developed with recommendations to improve the quality of reporting observational studies. The STROBE statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Multiple types of observational studies are conducted; however, 3 types have been highlighted in the

  2. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2014-01-01

    . Eleven trials (1969 patients) with subjective outcomes provided hazard ratios, RHR 0.88 (0.69 to 1.12), (I2=44%, P=0.06), but unconditional pooling was problematic because of qualitative heterogeneity. Four atypical cytomegalovirus retinitis trials compared experimental oral administration with control...... intravenous administration of the same drug, resulting in bias favouring the control intervention, RHR 1.33 (0.98 to 1.82). Seven trials of cytomegalovirus retinitis, tibial fracture and multiple sclerosis compared experimental interventions with standard control interventions, e.g. placebo, no...

  3. Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial

    International Nuclear Information System (INIS)

    Geraghty, John P; Grogan, Garry; Ebert, Martin A

    2013-01-01

    This study investigates the variation in segmentation of several pelvic anatomical structures on computed tomography (CT) between multiple observers and a commercial automatic segmentation method, in the context of quality assurance and evaluation during a multicentre clinical trial. CT scans of two prostate cancer patients (‘benchmarking cases’), one high risk (HR) and one intermediate risk (IR), were sent to multiple radiotherapy centres for segmentation of prostate, rectum and bladder structures according to the TROG 03.04 “RADAR” trial protocol definitions. The same structures were automatically segmented using iPlan software for the same two patients, allowing structures defined by automatic segmentation to be quantitatively compared with those defined by multiple observers. A sample of twenty trial patient datasets were also used to automatically generate anatomical structures for quantitative comparison with structures defined by individual observers for the same datasets. There was considerable agreement amongst all observers and automatic segmentation of the benchmarking cases for bladder (mean spatial variations < 0.4 cm across the majority of image slices). Although there was some variation in interpretation of the superior-inferior (cranio-caudal) extent of rectum, human-observer contours were typically within a mean 0.6 cm of automatically-defined contours. Prostate structures were more consistent for the HR case than the IR case with all human observers segmenting a prostate with considerably more volume (mean +113.3%) than that automatically segmented. Similar results were seen across the twenty sample datasets, with disagreement between iPlan and observers dominant at the prostatic apex and superior part of the rectum, which is consistent with observations made during quality assurance reviews during the trial. This study has demonstrated quantitative analysis for comparison of multi-observer segmentation studies. For automatic segmentation

  4. Recent clinical trials in idiopathic pulmonary fibrosis and the BUILD-1 study

    Directory of Open Access Journals (Sweden)

    K. K. Brown

    2008-12-01

    Full Text Available Idiopathic pulmonary fibrosis (IPF, the most common of the interstitial pneumonias, is a progressive, life-limiting disease for which there are no truly effective therapies. In patients with biopsy-confirmed IPF, median survival is still <3 yrs. Although potent immunosuppressive therapy has underpinned the treatment of IPF in recent years and remains the standard of care, there is little quality evidence to support the efficacy and safety of traditional therapeutic strategies. This has spurred the search for new treatments for IPF and has led to a series of clinical trials of new therapies, seven of which are reviewed herein. They include the Bosentan Use in Interstitial Lung Disease (BUILD-1 trial, the results of which are discussed in detail, the European Idiopathic Pulmonary Fibrosis International Group Exploring N-acetylcysteine 1 Annual (IFIGENIA trial, the interferon gamma (GIPF-001 trial and the INSPIRE trial, as well as trials of anticoagulant therapy, pirfenidone and etanercept. Treatment trials in IPF are hindered by difficulties in achieving a secure diagnosis of IPF and the lack of validated outcome measures that represent either improvement or progression of disease. These and other limitations are discussed in the present article, as well as how some of these problems might be addressed in future trials. Although few of the seven studies met their primary end-points, marginal trends either on primary end-points or statistically significant trends on exploratory end-points were a recurrent theme in most trials. In the BUILD-1 trial, for example, a trend in favour of bosentan was observed on time-to-disease progression or death.

  5. TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Gillian; O'Hara, James; Carding, Paul; Lecouturier, Jan; Stocken, Deborah; Fouweather, Tony; Wilson, Janet

    2016-04-01

    Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main trial sites. Further trial sites may be opened, as necessary. The main trial will continue for a further 18 months. Participants will be followed up for 12 months from randomisation, throughout which both primary and secondary outcome data will be collected. The primary outcome is change in Reflux Symptom Index (RSI) score, the 'area standard' for this type of assessment, after 16 weeks (four months) of treatment. Secondary outcomes are RSI changes at 12 months after randomisation, Quality of Life assessment at four and 12 months, laryngeal mucosal changes, assessments of compliance and side effects, and patient-reported satisfaction. TOPPITS is designed to evaluate the relative effectiveness of treatment with a proton pump inhibitor versus placebo in patients with persistent throat symptoms. This will provide valuable information to clinicians and GPs regarding the treatment and management of care for these patients, on changes in symptoms, and in Quality of Life, over time. ISRCTN

  6. Complicated Intra-Abdominal Infections Observational European study (CIAO Study

    Directory of Open Access Journals (Sweden)

    Sartelli Massimo

    2011-12-01

    Full Text Available Abstract Complicated intra-abdominal infections are frequently associated with poor prognoses and high morbidity and mortality rates. Despite advances in diagnosis, surgery, and antimicrobial therapy, mortality rates associated with complicated intra-abdominal infections remain exceedingly high. In order to describe the clinical, microbiological, and management-related profiles of both community-acquired and healthcare-acquired complicated intra-abdominal infections (IAIs, the World Society of Emergency Surgery (WSES, in collaboration with the Surgical Infections Society of Europe (SIS-E and other prominent European surgical societies, has designed the CIAO study. The CIAO study is a multicenter, observational study and will be carried out in various surgical departments throughout Europe. The study will include patients undergoing surgery or interventional drainage for complicated IAI.

  7. Management of rheumatic chorea: an observational study

    Directory of Open Access Journals (Sweden)

    Araújo Alexandra Prufer de Queiroz Campos

    2002-01-01

    Full Text Available BACKGROUND: Rheumatic chorea (RC has recently been linked to an antibody-mediated immune mechanism. OBJECTIVE/METHOD: To verify if this knowledge reflected in management changes we conceived a descriptive study. RESULTS: The medical charts of 20 children (13 females aged 6 to 12 years (mean 8 years, diagnosed as RC from June 1996 to June 1999, were reviewed. All patients received some medical treatment. Haloperidol was the most prescribed medication (15 patients - 75 %. Sulpiride, diazepam and valproate were also used as symptomatic treatment. Imune-modulating therapy with prednisone was prescribed for seven children. The shortest course of chorea (16 days occurred in a patient treated with prednisone. CONCLUSION: Prednisone has been prescribed for rheumatic chorea besides the traditional symptomatic approach. A great variety of antichoreic drugs are being employed.

  8. Extension Trial of Qigong for Fibromyalgia: A Quantitative and Qualitative Study

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2013-01-01

    Full Text Available This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60 min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to baselines, CFQ practice led to significant improvements in pain, impact, sleep, and physical function in the 13 subjects (65% who completed the trial; changes were present at 8 weeks and were maintained for the 6-month trial duration. A highly motivated subgroup of N=5, who practiced the most, had the best outcomes in terms of end symptomology, and qualitative comments indicated health benefits in other domains as well. Qualitative comments by the remaining N=8 trial completers and N=7 withdrawals indicate different experiences with the practice. This extension trial indicates that diligent CFQ practice over time produces significant health gains in fibromyalgia in a subset of individuals. Future studies will need to address factors that might predispose to favourable outcomes.

  9. Extension trial of qigong for fibromyalgia: a quantitative and qualitative study.

    Science.gov (United States)

    Sawynok, Jana; Lynch, Mary; Marcon, Dana

    2013-01-01

    This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ) training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60 min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to baselines, CFQ practice led to significant improvements in pain, impact, sleep, and physical function in the 13 subjects (65%) who completed the trial; changes were present at 8 weeks and were maintained for the 6-month trial duration. A highly motivated subgroup of N = 5, who practiced the most, had the best outcomes in terms of end symptomology, and qualitative comments indicated health benefits in other domains as well. Qualitative comments by the remaining N = 8 trial completers and N = 7 withdrawals indicate different experiences with the practice. This extension trial indicates that diligent CFQ practice over time produces significant health gains in fibromyalgia in a subset of individuals. Future studies will need to address factors that might predispose to favourable outcomes.

  10. [Difficult laryngoscopy and tracheal intubation: observational study].

    Science.gov (United States)

    Andrade, Rebeca Gonelli Albanez da Cunha; Lima, Bruno Luís Soares; Lopes, Douglas Kaíque de Oliveira; Couceiro Filho, Roberto Oliveira; Lima, Luciana Cavalcanti; Couceiro, Tania Cursino de Menezes

    Since anesthesia complications associated with unexpected difficult airway are potentially catastrophic, they should be avoided. The modified Mallampati test and jaw-thrust maneuver enable the identification of difficult airway. The aim of this study was to associate the modified Mallampati test and the jaw-thrust maneuver with laryngoscopy (Cormack-Lehane) in an attempt to identify a better predictor of difficult airway in an adult population undergoing elective surgery. A cross-sectional study in which 133 adult patients undergoing elective surgery requiring tracheal intubation were analyzed. The accuracy and specificity of the modified Mallampati test and jaw-thrust maneuver were assessed by correlating them with difficult laryngoscopy (Cormack-Lehane Degrees 3 and 4). In the 133 patients evaluated the difficult intubation rate found was 0.8%; there was association between the two predictive tests proposed (p=0.012). The values of 94.5% for specificity and 95.4% for accuracy were found for the jaw-thrust maneuver and for the modified Mallampati test, the values found were 81.1% and 81.2%, respectively. Kappa agreement identified a result of 0.240 between jaw-thrust maneuver and Cormarck-Lehane, which was considered reasonable. On the other hand, a poor agreement (κ=0.06) was seen between modified Mallampati test and Cormarck-Lehane test. The jaw-thrust maneuver presented superior accuracy and agreement than the modified Mallampati test, showing the ability to identify a difficult airway. It is necessary to emphasize the association of tests in the evaluation of patients, emphasizing their complementarity to minimize the negative consequences of repeated laryngoscopies. Copyright © 2017 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  11. Published intimate partner violence studies often differ from their trial registration records.

    Science.gov (United States)

    Madden, Kim; Tai, Kerry; Ali, Zak; Schneider, Patricia; Singh, Mahip; Ghert, Michelle; Bhandari, Mohit

    2017-12-27

    Registering study protocols in a trial registry is important for methodologic transparency and reducing selective reporting bias. The objective of this investigation was to determine whether published studies of intimate partner violence (IPV) that had been registered matched the registration record on key study design elements. We systematically searched three trial registries to identify registered IPV studies and the published literature for the associated publication. Two authors independently determined for each study whether key study elements in the registry matched those in the published paper. We included 66 studies published between 2006 and 2017. Nearly half (29/66, 44%) were registered after study completion. Many (26/66, 39%) had discrepancies regarding the primary outcome, and nearly two-thirds (42/66, 64%) had discrepancies in secondary outcomes. Discrepancies in study design were less frequent (13/66, 20%). However, large changes in sample size (26/66, 39%) and discrepancies in funding source (28/66, 42%) were frequently observed. Trial registries are important tools for research transparency and identifying and preventing outcome switching and selective outcome reporting bias. Published IPV studies often differ from their records in trial registries. Researchers should pay close attention to the accuracy of trial registry records.

  12. TORCH screening in polyhydramnios: an observational study.

    Science.gov (United States)

    Fayyaz, Humera; Rafi, Junaid

    2012-07-01

    The aim of this study was to understand the TORCH test and to evaluate its significance in women with polyhydramnios in singleton pregnancies. Retrospective analysis of indications and results of TORCH referrals made from November 2007 to 2009 with detailed review of case notes of women with polyhydramnios who had TORCH test. The total number of deliveries during specimen time was 3004, out of which 110(3.6%) had serum TORCH screening. The main indication for this test was polyhydramnios 62 (56.36%) followed by obstetric cholestasis 20 (18.18%), Intra-uterine fetal demise 6 (5.45%), fetal anomalies 5(4.54%), and deranged liver function tests (LFTs) 2 (1.8%). 15 (13.6%) women had TORCH screening for other indications such as clinical polyhydramnios, increased nuchal translucency (>2.5 mm). cytomegalovirus (CMV) and toxoplasmosis antibodies were tested in all cases whereas, parvovirus and herpes simplex virus screen were carried out in 4 (12.7%) and 2 (1.8%) patients, respectively. One woman (0.09%) had infection with CMV who had TORCH screening carried out for deranged LFTs. None of these women had positive TORCH screening giving the p value of TORCH test in polyhydramnios, the statistical evaluation shows that this test is not beneficial in women in whom polyhydramnios is an isolated ultrasound finding, especially when it is diagnosed in third trimester.

  13. Observational studies often make clinical practice recommendations: an empirical evaluation of authors' attitudes.

    Science.gov (United States)

    Prasad, Vinay; Jorgenson, Joel; Ioannidis, John P A; Cifu, Adam

    2013-04-01

    Although observational studies provide useful descriptive and correlative information, their role in the evaluation of medical interventions remains contentious. There has been no systematic evaluation of authors' attitudes toward their own nonrandomized studies and how often they recommend specific medical practices. We reviewed all original articles of nonrandomized studies published in 2010 in New England Journal of Medicine, Lancet, Journal of the American Medical Association, and Annals of Internal Medicine. We classified articles based on whether authors recommend a medical practice and whether they state that a randomized trial is needed to support their recommendation. We also examined the types of logical extrapolations used by authors who did advance recommendations. Of the 631 original articles published in 2010, 298 (47%) articles were eligible observational studies. In 167 (56%) of 298 studies, authors recommended a medical practice based on their results. Only 24 (14%) of 167 studies stated that a randomized controlled trial (RCT) should be done to validate the recommendation, whereas the other 143 articles made a total of 149 logical extrapolations to recommend specific medical practices. Recommendations without a call for a randomized trial were most common in studies of modifiable factors (59%), but they were also common in studies reporting incidence or prevalence (51%), studies examining novel tests (41%), and association studies of nonmodifiable factors (32%). The authors of observational studies often extrapolate their results to make recommendations concerning a medical practice, typically without first calling for a RCT. Published by Elsevier Inc.

  14. Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    Directory of Open Access Journals (Sweden)

    Gluud Christian

    2008-07-01

    Full Text Available Abstract Background A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. Objectives The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. Design The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1 specialized addiction treatment plus treatment as usual or 2 treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient. The primary outcome measure will be changes in amount of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. Trial registration ClinicalTrials.gov NCT00484302.

  15. [Therapeutic failure in scabies: An observational study].

    Science.gov (United States)

    De Sainte Marie, B; Mallet, S; Gaudy-Marqueste, C; Baumstarck, K; Bentaleb, N; Loundou, A; Hesse, S; Monestier, S; Grob, J-J; Richard, M-A

    2016-01-01

    Several sources suggest an escalation of scabies in France. To describe a population of patients continuing to present with scabies despite multiple treatments in order to identify factors associated with persistence of infection. A descriptive cross-sectional study in adults and children consulting for persistent scabies despite at least one previous treatment. A standardized questionnaire explored potential sources of treatment failure. Thirty-one patients were analyzed. Initial symptoms were noted to have started between two and 52 weeks earlier (mean: 19 weeks). The mean number of prior consultations with a general practitioner was 3.1 (0-10) and 1.7 with a dermatologist (0-7). The mean number of patients per household was 3.5 (1-9). At least one dose of oral ivermectin (maximum of 6 doses per household) was prescribed for 84 % of patients (29 % of whom were not fasted at the time). Further, 74 % of patients received at least one local application of esdepallethrin and piperonyl butoxide (maximum: 5 courses), four received benzyl benzoate and two received permethrin; however, 58 % did not reapply the substance after hand washing. All households bought the prescribed treatments despite the costs. Close contacts of patients were treated in 58 % of households. Decontamination of bedding and clothing was carried out properly in 90 % of households. Persistence of infection appears to be linked to: (1) insufficient treatment of close contacts; (2) absence of a second treatment between days 7 and 14; (3) insufficient efficacy of the available treatments, doubtless due to multiple factors (intrinsic resistance of Sarcoptes, failure to repeat treatment, poor explanation of methods for dosing and application, and oral intake of treatments). Access to non-reimbursed treatments was not identified as a problem and decontamination of bedding and clothing was correctly performed in most cases. Though certain fundamental aspects of scabies treatment must be better

  16. Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial.

    Directory of Open Access Journals (Sweden)

    Kim S Thomas

    2017-04-01

    , respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects.Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.Current Controlled Trials ISRCTN77261365.

  17. Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

    Science.gov (United States)

    Thomas, Kim S; Bradshaw, Lucy E; Sach, Tracey H; Batchelor, Jonathan M; Lawton, Sandra; Harrison, Eleanor F; Haines, Rachel H; Ahmed, Amina; Williams, Hywel C; Dean, Taraneh; Burrows, Nigel P; Pollock, Ian; Llewellyn, Joanne; Crang, Clare; Grundy, Jane D; Guiness, Juliet; Gribbin, Andrew; Mitchell, Eleanor J; Cowdell, Fiona; Brown, Sara J; Montgomery, Alan A

    2017-04-01

    , respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects. Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. Current Controlled Trials ISRCTN77261365.

  18. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

    Science.gov (United States)

    O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

    2014-06-01

    Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews

  19. Serial plasma choline measurements after cardiac arrest in patients undergoing mild therapeutic hypothermia: a prospective observational pilot trial.

    Directory of Open Access Journals (Sweden)

    Christian Storm

    Full Text Available OBJECTIVE: Choline is related to phospholipid metabolism and is a marker for global ischaemia with a small reference range in healthy volunteers. The aim of our study was to characterize the early kinetics of plasma free choline in patients after cardiac arrest. Additionally, we investigated the potential of plasma free choline to predict neurological outcome. METHODS: Twenty patients admitted to our medical intensive care unit were included in this prospective, observational trial. All patients were enrolled between May 2010 and May 2011. They received post cardiac arrest treatment including mild therapeutic hypothermia which was initiated with a combination of cold fluid and a feedback surface cooling device according to current guidelines. Sixteen blood samples per patient were analysed for plasma free choline levels within the first week after resuscitation. Choline was detected by liquid chromatography-tandem mass spectrometry. RESULTS: Most patients showed elevated choline levels on admission (median 14.8 µmol/L; interquartile range; IQR 9.9-20.1 which subsequently decreased. 48 hours after cardiac arrest choline levels in all patients reached subnormal levels at a median of 4.0 µmol/L (IQR 3-4.9; p = 0.001. Subsequently, choline levels normalized within seven days. There was no significant difference in choline levels when groups were analyzed in relation to neurological outcome. CONCLUSIONS: Our data indicate a choline deficiency in the early postresucitation phase. This could potentially result in impaired cell membrane recovery. The detailed characterization of the early choline time course may aid in planning of choline supplementation trials. In a limited number of patients, choline was not promising as a biomarker for outcome prediction.

  20. The COLOFOL trial: study design and comparison of the study population with the source cancer population

    Directory of Open Access Journals (Sweden)

    Hansdotter Andersson P

    2016-01-01

    Full Text Available Pernilla Hansdotter Andersson,1 Peer Wille-Jørgensen,2 Erzsébet Horváth-Puhó,3 Sune Høirup Petersen,2 Anna Martling,4 Henrik Toft Sørensen,3 Ingvar Syk1 On behalf of the COLOFOL Study Group 1Department of Surgery, Skåne University Hospital, Malmö, Sweden; 2Abdominal Disease Center K, Bispebjerg University Hospital, Copenhagen, Denmark; 3Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 4Department of Molecular Medicine and Surgery, Karolinska Institutet, Solna, Sweden Introduction: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. Materials and methods: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24 participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. Results: Of a total of 4,445 eligible patients, 2,509 patients were randomized (56.4% inclusion rate. A total of 1,221 eligible patients were identified in the scrutinized hospitals, of which 684 (56% were randomized. No difference in age or sex distribution was observed between randomized and nonrandomized

  1. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  2. A trial studying approach to predict college achievement

    NARCIS (Netherlands)

    Meijer, Rob R.; Niessen, A. Susan M.

    2015-01-01

    We argue that using trial studying is a reliable and valid way to select students for higher education. This method is based on a work sample approach often used in personnel selection contexts. We discuss that this method has predictive validity for study success, has high acceptance by

  3. Nonparametric estimation for censored mixture data with application to the Cooperative Huntington’s Observational Research Trial

    Science.gov (United States)

    Wang, Yuanjia; Garcia, Tanya P.; Ma, Yanyuan

    2012-01-01

    This work presents methods for estimating genotype-specific distributions from genetic epidemiology studies where the event times are subject to right censoring, the genotypes are not directly observed, and the data arise from a mixture of scientifically meaningful subpopulations. Examples of such studies include kin-cohort studies and quantitative trait locus (QTL) studies. Current methods for analyzing censored mixture data include two types of nonparametric maximum likelihood estimators (NPMLEs) which do not make parametric assumptions on the genotype-specific density functions. Although both NPMLEs are commonly used, we show that one is inefficient and the other inconsistent. To overcome these deficiencies, we propose three classes of consistent nonparametric estimators which do not assume parametric density models and are easy to implement. They are based on the inverse probability weighting (IPW), augmented IPW (AIPW), and nonparametric imputation (IMP). The AIPW achieves the efficiency bound without additional modeling assumptions. Extensive simulation experiments demonstrate satisfactory performance of these estimators even when the data are heavily censored. We apply these estimators to the Cooperative Huntington’s Observational Research Trial (COHORT), and provide age-specific estimates of the effect of mutation in the Huntington gene on mortality using a sample of family members. The close approximation of the estimated non-carrier survival rates to that of the U.S. population indicates small ascertainment bias in the COHORT family sample. Our analyses underscore an elevated risk of death in Huntington gene mutation carriers compared to non-carriers for a wide age range, and suggest that the mutation equally affects survival rates in both genders. The estimated survival rates are useful in genetic counseling for providing guidelines on interpreting the risk of death associated with a positive genetic testing, and in facilitating future subjects at risk

  4. HOW TO DESCRIBE THE RESULTS OF OBSERVATIONAL EPIDEMIOLOGICAL STUDIES

    Directory of Open Access Journals (Sweden)

    S. A. Shal'nova

    2016-01-01

    Full Text Available Principles and fundamentals of proper presentation of observational epidemiological study results are focused. Principles of observational study publication developed by expert epidemiologists (STROBE statement are explained in detail.

  5. A single center analysis of factors influencing study start-up timeline in clinical trials.

    Science.gov (United States)

    Krafcik, Brianna M; Doros, Gheorghe; Malikova, Marina A

    2017-11-01

    Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. The start-up milestones were assessed for 38 studies and analyzed. Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

  6. The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Tappin, David M; Bauld, Linda; Tannahill, Carol; de Caestecker, Linda; Radley, Andrew; McConnachie, Alex; Boyd, Kathleen; Briggs, Andrew; Grant, Liz; Cameron, Alan; Macaskill, Susan; Sinclair, Lesley; Friel, Brenda; Coleman, Tim

    2012-07-20

    Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: 'How to stop smoking in pregnancy and following childbirth' (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy.Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can

  7. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  8. The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial.

    Science.gov (United States)

    Vickers, Madge R; Martin, Jeannett; Meade, Tom W

    2007-02-26

    At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Randomised, placebo, controlled, trial. The trial was set in general practices in the UK (384), Australia (94), and New Zealand (24). In these practices 284175 women aged 50-69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 - 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. The trial was prematurely closed during recruitment following

  9. Observational study of outpatients with schizophrenia in the Middle ...

    African Journals Online (AJOL)

    Observational study of outpatients with schizophrenia in the Middle East and Africa — 3- and 6-month efficacy and safety results. The Intercontinental Schizophrenia Outpatient Health Outcomes Study.

  10. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke

    2014-01-01

    an important role in informing guideline developers and policy makers. Our aim was to investigate how far the nuclear medicine community has come on its way from accuracy studies to RCTs and which issues we have to take into account in planning future studies. METHODS: We conducted a systematic review...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome......, sufficient sample size, and current standard as comparator. RESULTS: Fourteen published and 15 planned studies were identified. Five of the published studies and 12 of the planned studies did not use a patient-important outcome. Sample sizes were often so small that a significant result could be expected...

  11. [Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].

    Science.gov (United States)

    Dal-Ré, Rafael; Delgado, Miguel; Bolumar, Francisco

    2015-01-01

    Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

  12. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

    2018-01-18

    Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a

  13. Effectiveness of psychotherapeutic consultation in the workplace: a controlled observational trial

    Directory of Open Access Journals (Sweden)

    Eva Rothermund

    2016-08-01

    Full Text Available Abstract Background This study compares the effectiveness of psychotherapeutic consultation in the workplace (PSIW with psychotherapeutic outpatient care (PSOC in Germany. Methods Work ability (WAI, quality of life (SF-12, clinical symptoms (PHQ and work-related stress (MBI, IS were assessed in 367 patients seeking mental health care via two routes (PSIW n = 174; PSOC n = 193 before consultation and 12 weeks later. Changes in outcome variables were assessed using covariance analysis with repeated measures (ANCOVA with sociodemographic variables (propensity score method, therapy dose, setting and symptom severity as covariates. Results The PSIW and PSOC groups included 122 and 66 men respectively. There were 102 first-time users of mental healthcare in the PSIW group and 83 in the PSOC group. There were group differences in outcome variables at baseline (p < 0.05; PSIW patients were less impaired overall. There were no group difference in sociodemographic variables, number of sessions within the offer or symptom severity. There was no main effect of group on outcome variables and no group*time interaction. Work-related stress indicators did not change during the intervention, but work ability improved in both groups (F = 10.149, p = 0.002; baseline M = 27.2, SD = 8.85; follow-up M = 28.6, SD = 9.02, as did perceived mental health (SF-12 MCS, depression (PHQ-9 and anxiety (PHQ-7. Effect sizes were between η2 = 0.028 and η2 = 0.040. Conclusions Psychotherapeutic consultation is similarly effective in improving patients’ functional and clinical status whether delivered in the workplace or in an outpatient clinic. Offering mental health services in the workplace makes it easier to reach patients at an earlier stage in their illness and thus enables provision of early and effective mental health care. Trial registration DRKS00003184 , retrospectively registered 13 January 2012.

  14. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  15. A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE).

    Science.gov (United States)

    Radwan, Noura; Phillips, Ryan; Ross, Ashley; Rowe, Steven P; Gorin, Michael A; Antonarakis, Emmanuel S; Deville, Curtiland; Greco, Stephen; Denmeade, Samuel; Paller, Channing; Song, Daniel Y; Diehn, Maximilian; Wang, Hao; Carducci, Michael; Pienta, Kenneth J; Pomper, Martin G; DeWeese, Theodore L; Dicker, Adam; Eisenberger, Mario; Tran, Phuoc T

    2017-06-29

    We describe a randomized, non-blinded Phase II interventional study to assess the safety and efficacy of stereotactic ablative radiotherapy (SABR) for hormone-sensitive oligometastatic prostate adenocarcinoma, and to describe the biology of the oligometastatic state using immunologic, cellular, molecular, and functional imaging correlates. 54 men with oligometastatic prostate adenocarcinoma will be accrued. The primary clinical endpoint will be progression at 6 months from randomization with the hypothesis that SABR to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints will include local control at 6 months post-SABR, toxicity and quality of life, and androgen deprivation therapy (ADT)-free survival (ADT-FS). Further fundamental analysis of the oligometastatic state with be achieved through correlation with investigational 18 F-DCFPyL PET/CT imaging and measurement of circulating tumor cells, circulating tumor DNA, and circulating T-cell receptor repertoires, facilitating an unprecedented opportunity to characterize, in isolation, the effects of SABR on the dynamics of and immunologic response to oligometastatic disease. Patients will be randomized 2:1 to SABR or observation with minimization to balance assignment by primary intervention, prior hormonal therapy, and PSA doubling time. Progression after 6 months will be compared using Fisher's exact test. Hazard ratios and Kaplan-Meier estimates of progression free survival (PFS), ADT free survival (ADT-FS), time to locoregional progression (TTLP) and time to distant progression (TTDP) will be calculated based on an intention-to-treat. Local control will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Withdrawal from the study prior to 6 months will be counted as progression. Adverse events will be summarized by type and grade. Quality of life pre- and post- SABR will be measured by Brief Pain Inventory. The ORIOLE

  16. Phase change material for thermotherapy of Buruli ulcer: a prospective observational single centre proof-of-principle trial.

    Directory of Open Access Journals (Sweden)

    Thomas Junghanss

    Full Text Available BACKGROUND: Buruli ulcer (BU is an infection of the subcutaneous tissue leading to chronic necrotizing skin ulcers. The causative pathogen, Mycobacterium ulcerans, grows best at 30 degrees C-33 degrees C and not above 37 degrees C. We explored the safety, tolerability and efficacy of phase change material (PCM, a novel heat application system for thermotherapy of BU. METHODOLOGY/PRINCIPAL FINDINGS: In a prospective observational single centre proof-of-principle trial in Ayos/Cameroon, six laboratory reconfirmed patients with ulcerative Buruli lesions received 28-31 (ulcers 2 cm days of thermotherapy with the PCM sodium acetate trihydrate as heat application system. This PCM is widely used in commercial pocket heat pads, it is easy to apply, rechargeable in hot water, non-toxic and non-hazardous to the environment. All patients enrolled in the trial completed treatment. Being completely mobile during the well-tolerated heat application, acceptability of the PCM bandages was very high. In patients with smaller ulcers, wounds healed completely without further intervention. Patients with large defects had skin grafting after successful heat treatment. Heat treatment was not associated with marked increases in local inflammation or the development of ectopic lymphoid tissue. One and a half years after completion of treatment, all patients are relapse-free. CONCLUSIONS/SIGNIFICANCE: Our reusable PCM-based heat application device appears perfectly suited to treat BU in endemic countries with limited resources and infrastructure. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88392614.

  17. Gender, Madness, Religion, and Iranian-American Identity: Observations on a 2006 Murder Trial in Williamsport, Pennsylvania

    Directory of Open Access Journals (Sweden)

    Camron Michael Amin

    2017-08-01

    Full Text Available Using participant observation, oral history interviews, and a study of court transcripts, Internet chats, and press coverage of a 2006 murder trial of an Iranian-American man in Williamsport, Pennsylvania, we can better appreciate the dynamic intersection of ethnicity, religion, and gender in constructing the social identity of Iranian-Americans. Brian Hosayn Yasipour, who immigrated to the United States in 1969, was convicted of murder in the third degree for killing his four-year-old daughter in 2001 during a custody dispute with his estranged, Iranian-born wife. He managed to avoid the death penalty. Debates about his guilt in America hinged on assessments of his mental state at the time of the crime and this, in turn, hinged on debates about how normative his actions would have been in Iran. Until his arrest, Brian had led a highly mobile life—moving back and forth between America, where he lived as a Christian, and Iran, where he visited as a Muslim. Was he a calculating Iranian-Islamic patriarch, outraged at the defiance of his wife and the attitudes of American courts toward his paternal rights? Or was he, per the court transcripts, a “white Christian” and survivor of childhood rape back in Iran, who lapsed into madness under the strain of his second divorce? Brian actively blurred these issues in court appearances before and after the murder—often expressing his agency in terms of preserving his imaginary and physical mobility.

  18. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    Science.gov (United States)

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally

  19. Ventilation strategies in burn intensive care: A retrospective observational study

    Directory of Open Access Journals (Sweden)

    Stefano Palazzo

    2014-01-01

    Full Text Available Consensus regarding optimal burns intensive care (BICU patient management is lacking. This study aimed to assess whether ventilation strategies, cardiovascular support and sedation in BICU patients have changed over time, and whether this affects outcome. A retrospective observational study comparing two 12-patient BICU cohorts (2005/06 and 2010/11 was undertaken. Demographic and admission characteristics, ventilation parameters, sedation, fluid resuscitation, cardiovascular support and outcome (length of stay, mortality data were collected from patient notes. Data was analysed using T-tests, Fisher's exact and Mann-Whitney U tests. In our study cohort groups were equivalent in demographic and admission parameters. There were equal ventilator-free days in the two cohorts 10 ± 12.7 vs. 13.3 ± 12.2 ventilator free days; P = 0.447. The 2005/06 cohort were mechanically ventilated more often than in 2010/11 cohort (568 ventilator days/1000 patient BICU days vs. 206 ventilator days/1000 patient BICU days; P = 0.001. The 2005/06 cohort were ventilated less commonly in tracheostomy group/endotracheal tube spontaneous (17.8% vs. 26%; P = 0.001 and volume-controlled modes (34.4% vs. 40.8%; P = 0.001. Patients in 2010/11 cohort were more heavily sedated (P = 0.001 with more long-acting sedative drug use (P = 0.001 than the 2005/06 cohort, fluid administration was equivalent. Patient outcome did not vary. Inhalational injury patients were ventilated in volume-controlled (44.5% vs. 28.1%; P = 0.001 and pressure-controlled modes (18.2% vs. 9.5%; P = 0.001 more frequently than those without. Outcome did not vary. This study showed there has been shift away from mechanical ventilation, with increased use of tracheostomy/tracheal tube airway spontaneous ventilation. Inhalation injury patients require more ventilatory support though patient outcomes do not differ. Prospective trials are required to establish which strategies confer benefit.

  20. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials

    DEFF Research Database (Denmark)

    Savović, Jelena; Jones, Hayley E; Altman, Douglas G

    2012-01-01

    bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes, with little evidence of bias in trials with objective and mortality outcomes. This study is limited by incomplete trial reporting, and findings may be confounded by other study design...

  1. Rates of cognitive change in Alzheimer disease: Observations across a decade of placebo-controlled clinical trials with donepezil

    DEFF Research Database (Denmark)

    Jones, Roy W; Schwam, Elias; Wilkinson, David

    2009-01-01

    Treatment success in Alzheimer disease (AD) trials is generally based on benefits over placebo-treated controls. Consequently, variation in rates of decline among placebo-treated patients could impact outcomes from AD trials. In the present analyses, individual patient data [baseline Mini......-Mental State Examination (MMSE): 10 to 26] were pooled from randomized, placebo-controlled studies of donepezil for AD conducted during the 1990s, and grouped by initiation year-group 1: 1990 to 1994; group 2: 1996 to 1999. Changes in MMSE and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS...

  2. Learning to observe mathematical learning in lesson studies

    DEFF Research Database (Denmark)

    Rasmussen, Klaus; Østergaard, Camilla Hellsten; Foss, Kristian Kildemoes

    2016-01-01

    This poster deals with lesson study (LS) in pre-service teacher education. In particular how to prepare for, carry out, and reflect upon, observations of pupil learning. Observation is of crucial importance to the lesson study process, and here we present a study of observation features which ena...... enable or hinder fruitful lesson study. While substantial research has been carried out in the general field of bserving pupils’ learning processes and teachers’ pedagogical practice, little is known about this in the particular setting of lesson study.......This poster deals with lesson study (LS) in pre-service teacher education. In particular how to prepare for, carry out, and reflect upon, observations of pupil learning. Observation is of crucial importance to the lesson study process, and here we present a study of observation features which...

  3. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  4. Comparison of study designs for acute otitis media trials.

    Science.gov (United States)

    Pichichero, Michael E; Casey, Janet R

    2008-06-01

    A framework for evaluating the efficacy of antibiotics in development as well as those currently approved for acute otitis media (AOM) is needed. Review strengths and limitations of various antibiotic trial designs and their outcome measures. A review of 157 published trials involving 36,710 subjects for the treatment of AOM. AOM trials have three designs: (1) clinical, clinical diagnosis and assessment of outcomes; (2) single tympanocentesis, microbiologic diagnosis (by middle ear fluid culture) and clinical assessment of outcomes; and (3) double tympanocentesis, microbiologic diagnosis and microbiologic outcome assessment. Identifiable strengths and limitations of each design are reviewed. Case definitions for entry of children in trials of AOM vary widely. The lack of stringent diagnostic criteria in a clinical design allows for inclusion of a significant proportion of children with a non-bacterial etiology (i.e., viral AOM or otitis media with effusion). Tympanocentesis increases diagnostic accuracy at study entry; however, the procedure is confounding because of its potentially therapeutic benefit and the procedure is not performed in a uniform manner. A second tympanocentesis allows a high sensitivity to detect microbiologic eradication, but it does not correlate with clinical outcomes in half of the cases. The timing of outcome assessment also varies widely among trials. Improved clinical diagnosis criteria for AOM are needed to enhance specificity; emphasis on a bulging tympanic membrane has the best evidence base. Tympanocentesis within study designs has merits. At study entry it assures diagnostic accuracy but may alter outcomes and it is useful to document microbiologic outcomes but lacks specificity for clinical outcomes. For all designs, test of cure assessment 2-7 days after completion of therapy seems most appropriate.

  5. Does the integration of personalized ultrasound change patient management in critical care medicine? Observational trials.

    Science.gov (United States)

    Breitkreutz, Raoul; Campo Delľ Orto, Marco; Hamm, Christian; Cuca, Colleen; Zechner, Peter M; Stenger, Tanja; Walcher, Felix; Seeger, Florian H

    2013-01-01

    Objective. To test the influence of personalized ultrasound (PersUS) on patient management in critical care. Design of the Study. Prospective, observational, and critical care setting. Four substudies compared PersUS and mobile ultrasound, work distribution, and diagnostic and procedural quality. Patients and Interventions. 640 patient ultrasound exams including 548 focused diagnostic exams and 92 interventional procedures. Main Outcome Measures. Number of studies, physician's judgement of feasibility, time of usage per patient, and referrals to echo lab. Results. Randomized availability of PersUS increased its application in ICU work shifts more than twofold from 33 to 68 exams mainly for detection and therapy of effusions. Diagnostic and procedural quality was rated as excellent/very good in PersUS-guided puncture in 95% of cases. Integrating PersUS within an initial physical examination of 48 randomized cases in an emergency department, PersUS extended the examination time by 100 seconds. Interestingly, PersUS integration into 53 randomized regular ward rounds of 1007 patients significantly reduced average contact time per patient by 103 seconds from 8.9 to 7.2 minutes. Moreover, it lowered the patient referral rate to an echo lab from 20% to 2% within the study population. Conclusions. We propose the development of novel ultrasound-based clinical pathways by integration of PersUS.

  6. Does the Integration of Personalized Ultrasound Change Patient Management in Critical Care Medicine? Observational Trials

    Directory of Open Access Journals (Sweden)

    Raoul Breitkreutz

    2013-01-01

    Full Text Available Objective. To test the influence of personalized ultrasound (PersUS on patient management in critical care. Design of the Study. Prospective, observational, and critical care setting. Four substudies compared PersUS and mobile ultrasound, work distribution, and diagnostic and procedural quality. Patients and Interventions. 640 patient ultrasound exams including 548 focused diagnostic exams and 92 interventional procedures. Main Outcome Measures. Number of studies, physician’s judgement of feasibility, time of usage per patient, and referrals to echo lab. Results. Randomized availability of PersUS increased its application in ICU work shifts more than twofold from 33 to 68 exams mainly for detection and therapy of effusions. Diagnostic and procedural quality was rated as excellent/very good in PersUS-guided puncture in 95% of cases. Integrating PersUS within an initial physical examination of 48 randomized cases in an emergency department, PersUS extended the examination time by 100 seconds. Interestingly, PersUS integration into 53 randomized regular ward rounds of 1007 patients significantly reduced average contact time per patient by 103 seconds from 8.9 to 7.2 minutes. Moreover, it lowered the patient referral rate to an echo lab from 20% to 2% within the study population. Conclusions. We propose the development of novel ultrasound-based clinical pathways by integration of PersUS.

  7. Does the Integration of Personalized Ultrasound Change Patient Management in Critical Care Medicine? Observational Trials

    Science.gov (United States)

    Breitkreutz, Raoul; Campo delľ Orto, Marco; Hamm, Christian; Cuca, Colleen; Zechner, Peter M.; Stenger, Tanja; Walcher, Felix; Seeger, Florian H.

    2013-01-01

    Objective. To test the influence of personalized ultrasound (PersUS) on patient management in critical care. Design of the Study. Prospective, observational, and critical care setting. Four substudies compared PersUS and mobile ultrasound, work distribution, and diagnostic and procedural quality. Patients and Interventions. 640 patient ultrasound exams including 548 focused diagnostic exams and 92 interventional procedures. Main Outcome Measures. Number of studies, physician's judgement of feasibility, time of usage per patient, and referrals to echo lab. Results. Randomized availability of PersUS increased its application in ICU work shifts more than twofold from 33 to 68 exams mainly for detection and therapy of effusions. Diagnostic and procedural quality was rated as excellent/very good in PersUS-guided puncture in 95% of cases. Integrating PersUS within an initial physical examination of 48 randomized cases in an emergency department, PersUS extended the examination time by 100 seconds. Interestingly, PersUS integration into 53 randomized regular ward rounds of 1007 patients significantly reduced average contact time per patient by 103 seconds from 8.9 to 7.2 minutes. Moreover, it lowered the patient referral rate to an echo lab from 20% to 2% within the study population. Conclusions. We propose the development of novel ultrasound-based clinical pathways by integration of PersUS. PMID:24455272

  8. Visual mismatch and predictive coding: A computational single-trial ERP study.

    Science.gov (United States)

    Stefanics, Gabor; Heinzle, Jakob; Attila Horváth, András; Enno Stephan, Klaas

    2018-03-26

    Predictive coding (PC) posits that the brain employs a generative model to infer the environmental causes of its sensory data and uses precision-weighted prediction errors (pwPE) to continuously update this model. While supported by much circumstantial evidence, experimental tests grounded in formal trial-by-trial predictions are rare. One partial exception are event-related potential (ERP) studies of the auditory mismatch negativity (MMN), where computational models have found signatures of pwPEs and related model-updating processes.Here, we tested this hypothesis in the visual domain, examining possible links between visual mismatch responses and pwPEs. We used a novel visual 'roving standard' paradigm to elicit mismatch responses in humans (of both sexes) by unexpected changes in either color or emotional expression of faces. Using a hierarchical Bayesian model, we simulated pwPE trajectories of a Bayes-optimal observer and used these to conduct a comprehensive trial-by-trial analysis across the time×sensor space. We found significant modulation of brain activity by both color and emotion pwPEs. The scalp distribution and timing of these single-trial pwPE responses were in agreement with visual mismatch responses obtained by traditional averaging and subtraction (deviant-minus-standard) approaches. Finally, we compared the Bayesian model to a more classical change detection (CD) model of MMN. Model comparison revealed that trial-wise pwPEs explained the observed mismatch responses better than categorical change detection.Our results suggest that visual mismatch responses reflect trial-wise pwPEs, as postulated by PC. These findings go beyond classical ERP analyses of visual mismatch and illustrate the utility of computational analyses for studying automatic perceptual processes. SIGNIFICANCE STATEMENT Human perception is thought to rely on a predictive model of the environment which is updated via precision-weighted prediction errors (pwPE) when events violate

  9. Early warning scoring systems versus standard observations charts for wards in South Africa: a cluster randomized controlled trial.

    Science.gov (United States)

    Kyriacos, Una; Jelsma, Jennifer; James, Michael; Jordan, Sue

    2015-03-20

    On South African public hospital wards, observation charts do not incorporate early warning scoring (EWS) systems to inform nurses when to summon assistance. The aim of this trial was to test the impact of a new chart incorporating a modified EWS (MEWS) system and a linked training program on nurses' responses to clinical deterioration (primary outcome). Secondary outcomes were: numbers of patients with vital signs recordings in the first eight postoperative hours; number of times each vital sign was recorded; and nurses' knowledge. A pragmatic, parallel-group, cluster randomized, controlled clinical trial of intervention versus standard care was conducted in three intervention and three control adult surgical wards in an 867-bed public hospital in Cape Town, between March and July 2010; thereafter the MEWS chart was withdrawn. A total of 50 out of 122 nurses in full-time employment participated. From 1,427 case notes, 114 were selected by randomization for assessment. The MEWS chart was implemented in intervention wards. Control wards delivered standard care, without training. Case notes were reviewed two weeks after the trial's completion. Knowledge was assessed in both trial arms by blinded independent marking of written tests before and after training of nurses in intervention wards. Analyses were undertaken with IBM SPSS software on an intention-to-treat basis. Patients in trial arms were similar. Introduction of the MEWS was not associated with statistically significant changes in responses to clinical deterioration (50 of 57 received no assistance versus 55 of 57, odds ratio (OR): 0.26, 95% confidence interval (CI): 0.05 to 1.31), despite improvement in nurses' knowledge in intervention wards. More patients in intervention than control wards had recordings of respiratory rate (27 of 57 versus 2 of 57, OR: 24.75, 95% CI: 5.5 to 111.3) and recordings of all seven parameters (5 of 57 versus 0 of 57 patients, risk estimate: 1.10, 95% CI: 1.01 to 1.2). A MEWS

  10. A prospective observational trial of pelvic floor muscle training for female stress urinary incontinence.

    Science.gov (United States)

    Balmforth, James R; Mantle, Jill; Bidmead, John; Cardozo, Linda

    2006-10-01

    To assess the impact of pelvic floor muscle training (PFMT) on bladder neck mobility in a prospective observational study, and to correlate any observed changes with objective, standardized outcome measures of the severity of stress urinary incontinence (SUI). Women with the symptom of SUI were recruited prospectively over a 3-year period from a tertiary referral urogynaecology clinic in a teaching hospital. A group of 97 treatment-naive women complaining of SUI and confirmed as having urodynamic SUI on video-urodynamic assessment agreed to participate. Bladder neck mobility on perineal ultrasonography was assessed immediately before and on completing a 14-week programme of 'PFM rehabilitation'. Treatment outcome was assessed using a standardized pad-test and a condition-specific, validated quality-of-life questionnaire (King's Health Questionnaire). Changes in functional anatomy were quantified using transperineal ultrasonography to measure the bladder neck position at rest, maximum PFM contraction and maximum Valsalva manoeuvre. Bladder neck rotational mobility from rest to maximum incursion and maximum excursion was calculated. Treatment with an intensive package of PFMT and behavioural modification resulted in significant elevation of the bladder neck position at all three measured positions. Displacement of the bladder neck on Valsalva (rotational excursion) was reduced after treatment, suggesting increased levator 'stiffness'. These changes in functional anatomy were associated with a statistically and clinically significant reduction in urine loss and improvement in condition-specific quality of life. The present results show that PFMT is an effective treatment for SUI and provide an important new insight into how dynamic pelvic floor anatomy can be modified by this widely used intervention.

  11. APPLICATION OF FILTEK SILORANE-INITIAL OBSERVATIONS AND PROSPECTIVE CLINICAL TRIAL FOR 12 MONTH

    Directory of Open Access Journals (Sweden)

    Lyubomir Vangelov

    2010-12-01

    Full Text Available Polymerization shrinkage and related adverse effects are still considered a major problem of dental composites. To solve this problem different approaches are offered. Currently, 3M ESPE developed a new monomer system based on cationic ring opening, the goal is to create a composite material with low polymerization shrinкage called siloran. Aim: To investigate the clinical presentation of Filtek д Silorane Low Shrink Posterior Restorative for an observation period of 12 months. Material and methods: The study included 36 patients. Total of 66 restorations are made. They were evaluated using modified USPHS criteria of Ryge and Cvar. After their assessment, restorations were captured with a digital camera and X-rays were taken in parallel technique. On control examination after one year, 31 patients (63 restorations were available for the study. Same parameters were assessed and new digital pictures and X-rays were made. The statistics was made with software SPSS version 17. For statistical analysis a Criterion Pirson (x2 was used. Results: With the exception of one of the criteria, it was shown that no statistically significant difference exists between the baseline and after one year (p> 0,05. Only the criterion surface of the filling was found to have statistically significant difference (p <0,05

  12. Concatenation of observed grasp phases with observer's distal movements: a behavioural and TMS study.

    Directory of Open Access Journals (Sweden)

    Elisa De Stefani

    Full Text Available The present study aimed at determining how actions executed by two conspecifics can be coordinated with each other, or more specifically, how the observation of different phases of a reaching-grasping action is temporary related to the execution of a movement of the observer. Participants observed postures of initial finger opening, maximal finger aperture, and final finger closing of grasp after observation of an initial hand posture. Then, they opened or closed their right thumb and index finger (experiments 1, 2 and 3. Response times decreased, whereas acceleration and velocity of actual finger movements increased when observing the two late phases of grasp. In addition, the results ruled out the possibility that this effect was due to salience of the visual stimulus when the hand was close to the target and confirmed an effect of even hand postures in addition to hand apparent motion due to the succession of initial hand posture and grasp phase. In experiments 4 and 5, the observation of grasp phases modulated even foot movements and pronunciation of syllables. Finally, in experiment 6, transcranial magnetic stimulation applied to primary motor cortex 300 ms post-stimulus induced an increase in hand motor evoked potentials of opponens pollicis muscle when observing the two late phases of grasp. These data suggest that the observation of grasp phases induced simulation which was stronger during observation of finger closing. This produced shorter response times, greater acceleration and velocity of the successive movement. In general, our data suggest best concatenation between two movements (one observed and the other executed when the observed (and simulated movement was to be accomplished. The mechanism joining the observation of a conspecific's action with our own movement may be precursor of social functions. It may be at the basis for interactions between conspecifics, and related to communication between individuals.

  13. Concatenation of observed grasp phases with observer's distal movements: a behavioural and TMS study.

    Science.gov (United States)

    De Stefani, Elisa; Innocenti, Alessandro; De Marco, Doriana; Gentilucci, Maurizio

    2013-01-01

    The present study aimed at determining how actions executed by two conspecifics can be coordinated with each other, or more specifically, how the observation of different phases of a reaching-grasping action is temporary related to the execution of a movement of the observer. Participants observed postures of initial finger opening, maximal finger aperture, and final finger closing of grasp after observation of an initial hand posture. Then, they opened or closed their right thumb and index finger (experiments 1, 2 and 3). Response times decreased, whereas acceleration and velocity of actual finger movements increased when observing the two late phases of grasp. In addition, the results ruled out the possibility that this effect was due to salience of the visual stimulus when the hand was close to the target and confirmed an effect of even hand postures in addition to hand apparent motion due to the succession of initial hand posture and grasp phase. In experiments 4 and 5, the observation of grasp phases modulated even foot movements and pronunciation of syllables. Finally, in experiment 6, transcranial magnetic stimulation applied to primary motor cortex 300 ms post-stimulus induced an increase in hand motor evoked potentials of opponens pollicis muscle when observing the two late phases of grasp. These data suggest that the observation of grasp phases induced simulation which was stronger during observation of finger closing. This produced shorter response times, greater acceleration and velocity of the successive movement. In general, our data suggest best concatenation between two movements (one observed and the other executed) when the observed (and simulated) movement was to be accomplished. The mechanism joining the observation of a conspecific's action with our own movement may be precursor of social functions. It may be at the basis for interactions between conspecifics, and related to communication between individuals.

  14. Standardised Observation Analogue Procedure (SOAP) for Assessing Parent and Child Behaviours in Clinical Trials

    Science.gov (United States)

    Johnson, Cynthia R.; Butter, Eric M.; Handen, Benjamin L.; Sukhodolsky, Denis G.; Mulick, James; Lecavalier, Luc; Aman, Michael G.; Arnold, Eugene L.; Scahill, Lawrence; Swiezy, Naomi; Sacco, Kelley; Stigler, Kimberly A.; McDougle, Christopher J.

    2009-01-01

    Background: Observational measures of parent and child behaviours have a long history in child psychiatric and psychological intervention research, including the field of autism and developmental disability. We describe the development of the Standardised Observational Analogue Procedure (SOAP) for the assessment of parent-child behaviour before…

  15. Observer variability in a phase II trial. Assessing consistency in RECIST application

    International Nuclear Information System (INIS)

    Skougaard, Kristin; Nielsen, Dorte; Vittrup Jensen, Benny; Dusgaard McCullagh, Mark James; Hjorth Johannesen, Helle; Westergren Hendel, Helle

    2012-01-01

    Objective: To assess the consistency of Response Evaluation Criteria in Solid Tumours (RECIST) application in a phase II trial. Material and methods: Patients with metastatic non-resectable colorectal cancer treated with a combination of an antibody and a chemotherapeutic drug, were included. Computed tomography (CT) scans (thorax, abdomen and pelvis) were performed at baseline and after every fourth treatment cycle. RECIST was intended for response evaluation. The scans were consecutively read by a heterogeneous group of radiologists as a part of daily work and hereafter retrospectively reviewed by a dedicated experienced radiologist. Agreement on best overall response (BOR) between readers and reviewer was quantified using κ-coefficients and the discrepancy rate was correlated with the number of different readers per patient using a χ 2 -test. Results: One hundred patients with 396 CT scans were included. Discrepancies between the readers and the reviewer were found in 47 patients. The majority of discrepancies concerned the application of RECIST. With the review, BOR changed in 17 patients, although, only in six patients the change was potentially treatment altering. Overall, the κ-coefficient of agreement between readers and reviewer was 0.71 (good). However, in the subgroup of responding patients the κ-coefficient was 0.21 (fair). The number of patients with discrepancies was significantly higher with three or more different readers per patient than with less (p =0.0003). Conclusion: RECIST was not consistently applied and the majority of the reader discrepancies were RECIST related. Post review, 17 patients changed BOR; six patients in a potentially treatment altering manner. Additionally, we found that the part of patients with discrepancies increased significantly with more than three different readers per patient. The findings support a peer-review approach where a few dedicated radiologists perform double blinded readings of all the on-going cancer

  16. Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Tilbrook, Helen; Forsythe, Rachael O; Rolfe, Debbie; Clark, Laura; Bland, Martin; Buckley, Hannah; Chetter, Ian; Cook, Liz; Dumville, Jo; Gabe, Rhian; Harding, Keith; Layton, Alison; Lindsay, Ellie; McDaid, Catriona; Moffatt, Christine; Phillips, Ceri; Stansby, Gerard; Vowden, Peter; Williams, Laurie; Torgerson, David; Hinchliffe, Robert J

    2015-11-10

    Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established. AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events. The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU. The study is registered on a public database with

  17. Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study.

    Science.gov (United States)

    Paramasivan, S; Rogers, C A; Welbourn, R; Byrne, J P; Salter, N; Mahon, D; Noble, H; Kelly, J; Mazza, G; Whybrow, P; Andrews, R C; Wilson, C; Blazeby, J M; Donovan, J L

    2017-11-01

    Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI). The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization. Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers. The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.

  18. Quality assessment of observational studies in psychiatry: an example  from perinatal psychiatric research.

    Science.gov (United States)

    Ross, L E; Grigoriadis, S; Mamisashvili, L; Koren, G; Steiner, M; Dennis, C-L; Cheung, A; Mousmanis, P

    2011-12-01

    In perinatal psychiatry, randomized controlled trials are often not feasible on ethical grounds. Many studies are observational in nature, while others employ large databases not designed primarily for research purposes. Quality assessment of the resulting research is complicated by a lack of standardized tools specifically for this purpose. The aim of this paper is to describe the Systematic Assessment of Quality in Observational Research (SAQOR), a quality assessment tool our team devised for a series of systematic reviews and meta-analyses of evidence-based literature regarding risks and benefits of antidepressant medication during pregnancy. Copyright © 2011 John Wiley & Sons, Ltd.

  19. Clinical Trials

    Medline Plus

    Full Text Available ... study results. Clinical Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  20. Diagnostic inaccuracy and subject exclusions render placebo and observational studies of acute otitis media inconclusive.

    Science.gov (United States)

    Pichichero, Michael E; Casey, Janet R

    2008-11-01

    Diagnostic accuracy and appropriate inclusion/exclusion criteria representative of children at greatest risk is of paramount importance in trials to evaluate placebo or observation as an option for acute otitis media (AOM) management. Twelve observational studies spanning the time frame 1958-2005 and 13 natural history studies spanning the time frame 1968-2006 were evaluated for the diagnostic criteria, inclusion criteria, and exclusion criteria applied within the study design. Although a bulging or full tympanic membrane (TM) with effusion is the best indication of a diagnosis of bacterial AOM based on tympanocentesis findings, few observational and natural history studies required a bulging TM. Examination of subject inclusion criteria showed that many subjects did not have AOM but rather had no middle ear disease at all or they had otitis media with effusion. Exclusion criteria of subjects were also remarkable. Frequently children bias in exclusion criteria among placebo/natural history trials in AOM. The current data favoring observation of children with AOM should be reconsidered until better studies are conducted.

  1. Epidemiological Study and Control Trial of Taeniid Cestode Infection in Farm Dogs in Qinghai Province, China

    OpenAIRE

    GUO, Zhihong; LI, Wei; PENG, Mao; DUO, Hong; SHEN, Xiuying; FU, Yong; IRIE, Takao; GAN, Tiantian; KIRINO, Yumi; NASU, Tetsuo; HORII, Yoichiro; NONAKA, Nariaki

    2013-01-01

    ABSTRACT An epidemiological study and control trial were conducted to assess taeniid infection in farm dogs in Qinghai Province, China. To improve egg detection by fecal examination, a deworming step with praziquantel was incorporated into the sampling methodology. As a result, a marked increase in the number of egg-positive samples was observed in samples collected at 24 hr after deworming. Then, the fecal examination and barcoding of egg DNA were performed to assess the prevalence of taenii...

  2. Observational studies and the difficult quest for causality

    DEFF Research Database (Denmark)

    Lipsitch, Marc; Jha, Ayan; Simonsen, Lone

    2016-01-01

    design: cohort, case-control and ecological studies. Studies of influenza VE, especially in seniors, are an excellent demonstration of the challenges of detecting and reducing such bias, and so we use influenza VE as a running example. We take a fresh look at the time-trend studies often dismissed...... more robust observational study designs, challenges lie ahead for evaluating best practices for achieving robust unbiased results from observational studies. This is critical for evaluation of national and global vaccine programme effectiveness....... be answered once the vaccine is in use, from observational studies. However, such studies are inherently at risk for bias. Using a causal framework and illustrating with examples, we review newer approaches to detecting and avoiding confounding and selection bias in three major classes of observational study...

  3. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)

    DEFF Research Database (Denmark)

    Vandenbroucke, Jan P; von Elm, Erik; Altman, Douglas G

    2014-01-01

    Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical...... considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate...... to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how...

  4. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Henaux, Pierre-Louis; Le Reste, Pierre-Jean; Laviolle, Bruno; Morandi, Xavier

    2017-06-05

    Chronic subdural hematoma (CSDH) is a common neurological pathology, especially in older patients. The actual "gold standard" of treatment is surgical evacuation, with various techniques used across neurosurgical teams. Over the years, there has been growing evidence that inflammatory processes play a major role in the pathogenesis of CSDH. In that context, the use of corticosteroids has been proposed alone or as an adjuvant treatment to surgery. However, this practice remains very empirical and there is a need for high-quality-of-evidence studies to clarify the role of corticosteroids in the management of CSDH. We propose a double-blind, randomized controlled trial comparing methylprednisolone versus placebo in the treatment of CSDH without clinical and/or radiological signs of severity. The treatment will be administered daily for a duration of 3 weeks, at a dose of 1 mg/kg. The primary endpoint will be the delay of occurrence of surgical treatment at 1 month following the introduction of the treatment. Secondary endpoints will include the rate of recourse to surgery, survival rate, quality of life and functional assessments, occurrence of systemic secondary effects and radiological assessment of the response to treatment. This multimodal assessment will be done at 1, 3 and 6 months. Two hundred and two patients (101 per arm) are expected to be included considering our primary hypotheses. This trial started in June 2016; its results may open interesting alternatives to surgery in the management of patients harboring a CSDH, and may provide insights into the natural history of this common pathology. ClinicalTrials.gov, ID: NCT02650609 . Registered on 4 January 2016. Graphical output of the OBF boundaries.

  5. Early rehospitalizations of frail elderly patients – the role of medications: a clinical, prospective, observational trial

    Directory of Open Access Journals (Sweden)

    Ekerstad N

    2017-08-01

    Full Text Available Niklas Ekerstad,1,2 Kristoffer Bylin,3 Björn W Karlson3,4 1Department of Cardiology, NU (NÄL-Uddevalla Hospital Group, Trollhättan, 2Department of Medical and Health Sciences, Division of Health Care Analysis, Linköping University, Linköping, 3Department of Acute and Internal Medicine, NU (NÄL-Uddevalla Hospital Group, Trollhättan, 4Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Background and objective: Early readmissions of frail elderly patients after an episode of hospital care are common and constitute a crucial patient safety outcome. Our purpose was to study the impact of medications on such early rehospitalizations. Patients and methods: This is a clinical, prospective, observational study on rehospitalizations within 30 days after an acute hospital episode for frail patients over the age of 75 years. To identify adverse drug reactions (ADRs, underuse of evidence-based treatment and avoidability of rehospitalizations, the Naranjo score, the Hallas criteria and clinical judgment were used. Results: Of 390 evaluable patients, 96 (24.6% were rehospitalized. The most frequent symptoms and conditions were dyspnea (n = 25 and worsened general condition (n = 18. The most frequent diagnoses were heart failure (n = 17 and pneumonia/acute bronchitis (n = 13. By logistic regression analysis, independent risk predictors for rehospitalization were heart failure (odds ratio [OR] = 1.8; 95% CI = 1.1–3.1 and anemia (OR = 2.3; 95% CI = 1.3–4.0. The number of rehospitalizations due to probable ADRs was 13, of which two were assessed as avoidable. The number of rehospitalizations probably due to underuse of evidence-based drug treatment was 19, all of which were assessed as avoidable. The number of rehospitalizations not due to ADRs or underuse of evidence-based drug treatment was 64, of which none was assessed as avoidable. Conclusion: One out of four

  6. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....

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

    Science.gov (United States)

    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.

  8. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine

    DEFF Research Database (Denmark)

    Ault, Kevin A; Joura, Elmar A; Kjaer, Susanne K

    2011-01-01

    The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysi...... HPV16/18-related, prophylactic HPV vaccination should reduce the incidence of invasive adenocarcinoma.......The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis......, we include all women who had at least one follow-up visit postenrollment. Healthy women (17,622) aged 15-26 with no history of HPV disease and a lifetime number of less than five sex partners (average follow-up of 3.6 years) were randomized (1:1) to receive vaccine or placebo at day 1, months 2...

  9. A review and additional post-hoc analyses of the incidence and impact of constipation observed in darifenacin clinical trials

    Directory of Open Access Journals (Sweden)

    Tack J

    2012-09-01

    Full Text Available Jan Tack,1 Jean-Jacques Wyndaele,2 Greg Ligozio,3 Mathias Egermark41University of Leuven, Gastroenterology Section, Leuven, 2University of Antwerp, Department of Urology, Antwerp, Belgium; 3Novartis Pharmaceuticals Corporation, NJ, USA; 4Roche Diagnostics Scandinavia AB, Bromma, Sweden and formerly of Novartis Pharma AG, Basel, SwitzerlandBackground: Constipation is a common side effect of antimuscarinic treatment for overactive bladder (OAB. This review evaluates the incidence and impact of constipation on the lives of patients with OAB being treated with darifenacin.Methods: Constipation data from published Phase III and Phase IIIb/IV darifenacin studies were reviewed and analyzed. Over 4000 patients with OAB (aged 18–89 years; ≥80% female enrolled in nine studies (three Phase III [data from these fixed-dose studies were pooled and provide the primary focus for this review], three Phase IIIb, and three Phase IV. The impact of constipation was assessed by discontinuations, use of concomitant laxatives, patient-reported perception of treatment, and a bowel habit questionnaire.Results: In the pooled Phase III trials, 14.8% (50/337 of patients on darifenacin 7.5 mg/day and 21.3% (71/334 on 15 mg/day experienced constipation compared with 12.6% (28/223 and 6.2% (24/388 with tolterodine and placebo, respectively. In addition, a few patients discontinued treatment due to constipation (0.6% [2/337], 1.2% [4/334], 1.8% [4/223], and 0.3% [1/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively, or required concomitant laxatives (3.3% [11/337], 6.6% [22/334], 7.2% [16/223], and 1.5% [6/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively. Patient-reported perception of treatment quality was observed to be similar between patients who experienced constipation and those who did not. During the long-term extension study, a bowel habit questionnaire showed only small

  10. Observer reliability of CT angiography in the assessment of acute ischaemic stroke: data from the Third International Stroke Trial

    Energy Technology Data Exchange (ETDEWEB)

    Mair, Grant; Farrall, Andrew J.; Sellar, Robin J.; Mollison, Daisy; Sakka, Eleni; Palmer, Jeb; Wardlaw, Joanna M. [University of Edinburgh, Western General Hospital, Division of Neuroimaging Sciences, Edinburgh (United Kingdom); Kummer, Ruediger von [Dresden University Stroke Centre, University Hospital, Department of Neuroradiology, Dresden (Germany); Adami, Alessandro [Sacro Cuore-Don Calabria Hospital, Stroke Center, Department of Neurology, Negrar (Italy); White, Philip M. [Stroke Research Group, Newcastle upon Tyne (United Kingdom); Adams, Matthew E. [National Hospital for Neurology and Neurosurgery, Department of Neuroradiology, London (United Kingdom); Yan, Bernard [Royal Melbourne Hospital, Neurovascular Research Group, Parkville (Australia); Demchuk, Andrew M. [Calgary Stroke Program, Department of Clinical Neurosciences, Calgary (Canada); Ramaswamy, Rajesh; Rodrigues, Mark A.; Samji, Karim; Baird, Andrew J. [Royal Infirmary of Edinburgh, Department of Radiology, Edinburgh (United Kingdom); Boyd, Elena V. [Northwick Park Hospital, Department of Radiology, Harrow (United Kingdom); Cohen, Geoff; Perry, David; Sandercock, Peter A.G. [University of Edinburgh, Western General Hospital, Division of Clinical Neurosciences, Edinburgh (United Kingdom); Lindley, Richard [University of Sydney, Westmead Hospital Clinical School and The George Institute for Global Health, Sydney (Australia); Collaboration: The IST-3 Collaborative Group

    2014-10-07

    CT angiography (CTA) is often used for assessing patients with acute ischaemic stroke. Only limited observer reliability data exist. We tested inter- and intra-observer reliability for the assessment of CTA in acute ischaemic stroke. We selected 15 cases from the Third International Stroke Trial (IST-3, ISRCTN25765518) with various degrees of arterial obstruction in different intracranial locations on CTA. To assess inter-observer reliability, seven members of the IST-3 expert image reading panel (>5 years experience reading CTA) and seven radiology trainees (<2 years experience) rated all 15 scans independently and blind to clinical data for: presence (versus absence) of any intracranial arterial abnormality (stenosis or occlusion), severity of arterial abnormality using relevant scales (IST-3 angiography score, Thrombolysis in Cerebral Infarction (TICI) score, Clot Burden Score), collateral supply and visibility of a perfusion defect on CTA source images (CTA-SI). Intra-observer reliability was assessed using independently repeated expert panel scan ratings. We assessed observer agreement with Krippendorff's-alpha (K-alpha). Among experienced observers, inter-observer agreement was substantial for the identification of any angiographic abnormality (K-alpha = 0.70) and with an angiography assessment scale (K-alpha = 0.60-0.66). There was less agreement for grades of collateral supply (K-alpha = 0.56) or for identification of a perfusion defect on CTA-SI (K-alpha = 0.32). Radiology trainees performed as well as expert readers when additional training was undertaken (neuroradiology specialist trainees). Intra-observer agreement among experts provided similar results (K-alpha = 0.33-0.72). For most imaging characteristics assessed, CTA has moderate to substantial observer agreement in acute ischaemic stroke. Experienced readers and those with specialist training perform best. (orig.)

  11. Observer reliability of CT angiography in the assessment of acute ischaemic stroke: data from the Third International Stroke Trial

    International Nuclear Information System (INIS)

    Mair, Grant; Farrall, Andrew J.; Sellar, Robin J.; Mollison, Daisy; Sakka, Eleni; Palmer, Jeb; Wardlaw, Joanna M.; Kummer, Ruediger von; Adami, Alessandro; White, Philip M.; Adams, Matthew E.; Yan, Bernard; Demchuk, Andrew M.; Ramaswamy, Rajesh; Rodrigues, Mark A.; Samji, Karim; Baird, Andrew J.; Boyd, Elena V.; Cohen, Geoff; Perry, David; Sandercock, Peter A.G.; Lindley, Richard

    2015-01-01

    CT angiography (CTA) is often used for assessing patients with acute ischaemic stroke. Only limited observer reliability data exist. We tested inter- and intra-observer reliability for the assessment of CTA in acute ischaemic stroke. We selected 15 cases from the Third International Stroke Trial (IST-3, ISRCTN25765518) with various degrees of arterial obstruction in different intracranial locations on CTA. To assess inter-observer reliability, seven members of the IST-3 expert image reading panel (>5 years experience reading CTA) and seven radiology trainees (<2 years experience) rated all 15 scans independently and blind to clinical data for: presence (versus absence) of any intracranial arterial abnormality (stenosis or occlusion), severity of arterial abnormality using relevant scales (IST-3 angiography score, Thrombolysis in Cerebral Infarction (TICI) score, Clot Burden Score), collateral supply and visibility of a perfusion defect on CTA source images (CTA-SI). Intra-observer reliability was assessed using independently repeated expert panel scan ratings. We assessed observer agreement with Krippendorff's-alpha (K-alpha). Among experienced observers, inter-observer agreement was substantial for the identification of any angiographic abnormality (K-alpha = 0.70) and with an angiography assessment scale (K-alpha = 0.60-0.66). There was less agreement for grades of collateral supply (K-alpha = 0.56) or for identification of a perfusion defect on CTA-SI (K-alpha = 0.32). Radiology trainees performed as well as expert readers when additional training was undertaken (neuroradiology specialist trainees). Intra-observer agreement among experts provided similar results (K-alpha = 0.33-0.72). For most imaging characteristics assessed, CTA has moderate to substantial observer agreement in acute ischaemic stroke. Experienced readers and those with specialist training perform best. (orig.)

  12. Competition Between Fusarium pseudograminearum and Cochliobolus sativus Observed in Field and Greenhouse Studies.

    Science.gov (United States)

    Troth, Erin E Gunnink; Johnston, Jeffrey A; Dyer, Alan T

    2018-02-01

    Among root pathogens, one of the most documented antagonisms is the suppression of Cochliobolus sativus by Fusarium (roseum) species. Unfortunately, previous studies involved single isolates of each pathogen and thus, provided no indication of the spectrum of responses that occur across the respective species. To investigate the variability in interactions between Cochliobolus sativus and Fusarium pseudograminearum, field and greenhouse trials were conducted that included monitoring of spring wheat plant health and monitoring of pathogen populations via quantitative real-time polymerase chain reaction. The interactions between two isolates of C. sativus and four isolates of F. pseudograminearum were explored in three geographically distinct wheat fields. To complement field trials and to limit potentially confounding environmental variables that are often associated with field studies, greenhouse trials were performed that investigated the interactions among and between three isolates of C. sativus and four isolates of F. pseudograminearum. Across field locations, C. sativus isolate Cs2344 consistently and significantly reduced Fusarium populations by an average of 20.1%. Similarly, F. pseudograminearum isolate Fp2228 consistently and significantly reduced C. sativus field populations by an average of 30.9%. No interaction was detected in the field between pathogen species with regards to disease or crop losses. Greenhouse results confirmed a powerful (>99%), broadly effective suppression of Fusarium populations by isolate Cs2344. Among greenhouse trials, additional isolate-isolate interactions were observed affecting Fusarium populations. Due to lower C. sativus population sizes in greenhouse trials, significant Fusarium suppression of C. sativus was only detected in one isolate-isolate interaction. This study is the first to demonstrate suppression of Fusarium spp. by C. sativus in field and greenhouse settings. These findings also reveal a complex competitive

  13. Are multiple-trial experiments appropriate for eyewitness identification studies? Accuracy, choosing, and confidence across trials.

    Science.gov (United States)

    Mansour, J K; Beaudry, J L; Lindsay, R C L

    2017-12-01

    Eyewitness identification experiments typically involve a single trial: A participant views an event and subsequently makes a lineup decision. As compared to this single-trial paradigm, multiple-trial designs are more efficient, but significantly reduce ecological validity and may affect the strategies that participants use to make lineup decisions. We examined the effects of a number of forensically relevant variables (i.e., memory strength, type of disguise, degree of disguise, and lineup type) on eyewitness accuracy, choosing, and confidence across 12 target-present and 12 target-absent lineup trials (N = 349; 8,376 lineup decisions). The rates of correct rejections and choosing (across both target-present and target-absent lineups) did not vary across the 24 trials, as reflected by main effects or interactions with trial number. Trial number had a significant but trivial quadratic effect on correct identifications (OR = 0.99) and interacted significantly, but again trivially, with disguise type (OR = 1.00). Trial number did not significantly influence participants' confidence in correct identifications, confidence in correct rejections, or confidence in target-absent selections. Thus, multiple-trial designs appear to have minimal effects on eyewitness accuracy, choosing, and confidence. Researchers should thus consider using multiple-trial designs for conducting eyewitness identification experiments.

  14. A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.

    Science.gov (United States)

    Brown, Justin C; Troxel, Andrea B; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S; Rickels, Michael R; Rhim, Andrew D; Rustgi, Anil K; Courneya, Kerry S; Schmitz, Kathryn H

    2016-03-01

    Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the courage trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the courage trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week(-1)) and high-dose (300 min·week(-1)) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (Pclinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Emergency Department Triage of Traumatic Head Injury Using a Brain Electrical Activity Biomarker: A Multisite Prospective Observational Validation Trial.

    Science.gov (United States)

    Hanley, Daniel; Prichep, Leslie S; Bazarian, Jeffrey; Huff, J Stephen; Naunheim, Rosanne; Garrett, John; Jones, Elizabeth B; Wright, David W; O'Neill, John; Badjatia, Neeraj; Gandhi, Dheeraj; Curley, Kenneth C; Chiacchierini, Richard; O'Neil, Brian; Hack, Dallas C

    2017-05-01

    A brain electrical activity biomarker for identifying traumatic brain injury (TBI) in emergency department (ED) patients presenting with high Glasgow Coma Scale (GCS) after sustaining a head injury has shown promise for objective, rapid triage. The main objective of this study was to prospectively evaluate the efficacy of an automated classification algorithm to determine the likelihood of being computed tomography (CT) positive, in high-functioning TBI patients in the acute state. Adult patients admitted to the ED for evaluation within 72 hours of sustaining a closed head injury with GCS 12 to 15 were candidates for study. A total of 720 patients (18-85 years) meeting inclusion/exclusion criteria were enrolled in this observational, prospective validation trial, at 11 U.S. EDs. GCS was 15 in 97%, with the first and third quartiles being 15 (interquartile range = 0) in the study population at the time of the evaluation. Standard clinical evaluations were conducted and 5 to 10 minutes of electroencephalogram (EEG) was acquired from frontal and frontal-temporal scalp locations. Using an a priori derived EEG-based classification algorithm developed on an independent population and applied to this validation population prospectively, the likelihood of each subject being CT+ was determined, and performance metrics were computed relative to adjudicated CT findings. Sensitivity of the binary classifier (likely CT+ or CT-) was 92.3% (95% confidence interval [CI] = 87.8%-95.5%) for detection of any intracranial injury visible on CT (CT+), with specificity of 51.6% (95% CI = 48.1%-55.1%) and negative predictive value (NPV) of 96.0% (95% CI = 93.2%-97.9%). Using ternary classification (likely CT+, equivocal, likely CT-) demonstrated enhanced sensitivity to traumatic hematomas (≥1 mL of blood), 98.6% (95% CI = 92.6%-100.0%), and NPV of 98.2% (95% CI = 95.5%-99.5%). Using an EEG-based biomarker high accuracy of predicting the likelihood of being CT+ was obtained, with

  16. The EULAR Study Group for Registers and Observational Drug Studies

    DEFF Research Database (Denmark)

    Kearsley-Fleet, Lianne; Závada, Jakub; Hetland, Merete Lund

    2015-01-01

    OBJECTIVE: Under the auspices of the European League Against Rheumatism (EULAR), a study group of investigators representing European biologic DMARD (bDMARD) registers was convened. The purpose of this initial assessment was to collect and compare a cross section of patient characteristics...

  17. Overview of the epidemiology methods and applications: strengths and limitations of observational study designs.

    Science.gov (United States)

    Colditz, Graham A

    2010-01-01

    The impact of study design on the results of medical research has long been an area of both substantial debate and a smaller body of empirical research. Examples come from many disciplines within clinical and public health research. Among the early major contributions in the 1970s was work by Mosteller and colleagues (Gilbert et al., 1997), who noted that innovations in surgery and anesthesia showed greater gains than standard therapy when nonrandomized, controlled trials were evaluated compared with the gains reported in randomized, controlled trials. More recently, we and others have evaluated the impact of design in medical and surgical research, and concluded that the mean gain comparing new therapies to established therapies was biased by study design in nonrandomized trials (Colditz et al., 1989; Miller et al., 1989). Benson and Hartz (2000) conducted a study in which they focused only on studies reported after 1985. On the basis of 136 reports of 19 diverse treatments, Benson and Hartz concluded that in only 2 of the 19 analyses did the combined data from the observational studies lie outside the 95% confidence interval for the combined data from the randomized trials. A similar study drew only on data reported from 1991 to 1995, which showed remarkably similar results among observational studies and randomized, controlled trials (Concato et al., 2000). These more recent data suggest that advancing the study design and analytic methods may reduce bias in some evaluations of medical and public health interventions. Such methods apply not only to the original studies, but also to the approaches that are taken to quantitatively combine results by using meta-analytic approaches such as random effects meta-regression, Bayesian meta-analysis, and the like (Normand, 1999). By focusing attention on thorough data analysis, design issues can be understood and their impact or bias can be estimated, on average, and then ideally accounted for in the interpretation of

  18. On sensitivity value of pair-matched observational studies

    OpenAIRE

    Zhao, Qingyuan

    2017-01-01

    An observational study may be biased for estimating causal effects by failing to control for unmeasured confounders. This paper proposes a new quantity called the "sensitivity value", which is defined as the minimum strength of unmeasured confounders needed to change the qualitative conclusions of a naive analysis assuming no unmeasured confounder. We establish the asymptotic normality of the sensitivity value in pair-matched observational studies. The theoretical results are then used to app...

  19. Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

    Science.gov (United States)

    de Rooij, Thijs; van Hilst, Jony; Vogel, Jantien A; van Santvoort, Hjalmar C; de Boer, Marieke T; Boerma, Djamila; van den Boezem, Peter B; Bonsing, Bert A; Bosscha, Koop; Coene, Peter-Paul; Daams, Freek; van Dam, Ronald M; Dijkgraaf, Marcel G; van Eijck, Casper H; Festen, Sebastiaan; Gerhards, Michael F; Groot Koerkamp, Bas; Hagendoorn, Jeroen; van der Harst, Erwin; de Hingh, Ignace H; Dejong, Cees H; Kazemier, Geert; Klaase, Joost; de Kleine, Ruben H; van Laarhoven, Cornelis J; Lips, Daan J; Luyer, Misha D; Molenaar, I Quintus; Nieuwenhuijs, Vincent B; Patijn, Gijs A; Roos, Daphne; Scheepers, Joris J; van der Schelling, George P; Steenvoorde, Pascal; Swijnenburg, Rutger-Jan; Wijsman, Jan H; Abu Hilal, Moh'd; Busch, Olivier R; Besselink, Marc G

    2017-04-08

    Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

  20. Impossibility to eliminate observer effect in the assessment of adherence in clinical trials.

    Science.gov (United States)

    Myers, Jonathan S; Fudemberg, Scott J; Fintelmann, Robert E; Hark, Lisa A; Khanna, Nitasha; Leiby, Benjamin E; Waisbourd, Michael

    2016-01-01

    To utilize the Travoprost Dosing Aid (DA) in the assessment of patient medication adherence, while also determining whether or not altering the functionality of the DA in three randomized subject groups can reduce observer effect. Forty-five subjects were randomized into three groups: two with monitored DAs and one without monitoring. One group of subjects was given a DA that both monitored drop usage and had visual and audible alarms, while the other monitored group included subjects given a DA that had no alarms but continued to monitor drop usage. The third group was given a DA that had no alarm reminders or dose usage monitoring. Subjects were informed that some monitors would not be functional, in an attempt to reduce observer effect, or the effect of being monitored on subject behavior and adherence. A six-item questionnaire was also utilized to assess how the subjects felt about their adherence and DA use. The overall adherence rates were found to be 78% in the fully functional group (95% confidence interval: 70-88) and 76% in the no alarms group (95% confidence interval: 65-89). No association was seen between questionnaire response and medication adherence. The patients in the DA group without alarms had a significantly higher odds ratio of medication adherence if they reported on the questionnaire that using the DA did affect how much they used their drops. Though the use of DA was expected to reveal different rates of adherence depending on the functionality of the DA between groups, patients with a nonfunctioning DA did not have a significant difference in medication adherence compared to those given a fully functional DA. This supports that an observer effect was not reduced despite these interventions, and that the subjects adhered to taking their medications as if they had a functioning DA and were being monitored.

  1. Impossibility to eliminate observer effect in the assessment of adherence in clinical trials

    Directory of Open Access Journals (Sweden)

    Myers JS

    2016-10-01

    Full Text Available Jonathan S Myers,1 Scott J Fudemberg,1 Robert E Fintelmann,2 Lisa A Hark,1 Nitasha Khanna,1 Benjamin E Leiby,3 Michael Waisbourd1 1Wills Eye Hospital, Glaucoma Research Center, Philadelphia, PA, 2Barnet Dulaney Perkins Eye Center, Phoenix, AZ, 3Division of Biostatistics, Thomas Jefferson University, Philadelphia, PA, USA Purpose: To utilize the Travoprost Dosing Aid (DA in the assessment of patient medication adherence, while also determining whether or not altering the functionality of the DA in three randomized subject groups can reduce observer effect. Methods: Forty-five subjects were randomized into three groups: two with monitored DAs and one without monitoring. One group of subjects was given a DA that both monitored drop usage and had visual and audible alarms, while the other monitored group included subjects given a DA that had no alarms but continued to monitor drop usage. The third group was given a DA that had no alarm reminders or dose usage monitoring. Subjects were informed that some monitors would not be functional, in an attempt to reduce observer effect, or the effect of being monitored on subject behavior and adherence. A six-item questionnaire was also utilized to assess how the subjects felt about their adherence and DA use. Results: The overall adherence rates were found to be 78% in the fully functional group (95% confidence interval: 70–88 and 76% in the no alarms group (95% confidence interval: 65–89. No association was seen between questionnaire response and medication adherence. The patients in the DA group without alarms had a significantly higher odds ratio of medication adherence if they reported on the questionnaire that using the DA did affect how much they used their drops. Conclusion: Though the use of DA was expected to reveal different rates of adherence depending on the functionality of the DA between groups, patients with a nonfunctioning DA did not have a significant difference in medication adherence

  2. Treatment of breast cancer during pregnancy: an observational study.

    Science.gov (United States)

    Loibl, Sibylle; Han, Sileny N; von Minckwitz, Gunter; Bontenbal, Marijke; Ring, Alistair; Giermek, Jerzy; Fehm, Tanja; Van Calsteren, Kristel; Linn, Sabine C; Schlehe, Bettina; Gziri, Mina Mhallem; Westenend, Pieter J; Müller, Volkmar; Heyns, Liesbeth; Rack, Brigitte; Van Calster, Ben; Harbeck, Nadia; Lenhard, Miriam; Halaska, Michael J; Kaufmann, Manfred; Nekljudova, Valentina; Amant, Frederic

    2012-09-01

    Little is known about the treatment of breast cancer during pregnancy. We aimed to determine whether treatment for breast cancer during pregnancy is safe for both mother and child. We recruited patients from seven European countries with a primary diagnosis of breast cancer during pregnancy; data were collected retrospectively if the patient was diagnosed before April, 2003 (when the registry began), or prospectively thereafter, irrespective of the outcome of pregnancy and the type and timing of treatment. The primary endpoint was fetal health for up to 4 weeks after delivery. The registry is ongoing. The study is registered with ClinicalTrials.gov, number NCT00196833. From April, 2003, to December, 2011, 447 patients were registered, 413 of whom had early breast cancer. Median age was 33 years (range 22-51). At the time of diagnosis, median gestational age was 24 weeks (range 5-40). 197 (48%) of 413 women received chemotherapy during pregnancy with a median of four cycles (range one to eight). 178 received an anthracycline, 15 received cyclophosphamide, methotrexate, and fluorouracil, and 14 received a taxane. Birthweight was affected by chemotherapy exposure after adjustment for gestational age (p=0·018), but not by number of chemotherapy cycles (p=0·71). No statistical difference between the two groups was observed for premature deliveries before the 37th week of gestation. 40 (10%) of 386 infants had side-effects, malformations, or new-born complications; these events were more common in infants born before the 37th week of gestation than they were in infants born in the 37th week or later (31 [16%] of 191 infants vs nine [5%] of 195 infants; p=0·0002). In infants for whom maternal treatment was known, adverse events were more common in those who received chemotherapy in utero compared with those who were not exposed (31 [15%] of 203 vs seven [4%] of 170 infants; p=0·00045). Two infants died; both were exposed to chemotherapy and delivered prematurely, but

  3. A pilot feeding study for adults with asthma: The healthy eating better breathing trial.

    Directory of Open Access Journals (Sweden)

    Emily P Brigham

    Full Text Available Evidence from observational studies and to a lesser extent clinical trials suggest that a healthy diet may improve symptoms and lung function in patients with asthma. We conducted a pilot study to determine the feasibility of conducting a larger scale dietary trial and to provide preliminary evidence on the impact of a healthy diet on asthma outcomes.In a randomized, two period cross-over trial, participants with asthma received a 4-week dietary intervention followed by a usual diet (or vice versa, separated by a 4-week washout. The dietary intervention was a healthy diet rich in unsaturated fat. During the dietary intervention, participants ate three meals per week on site at the Johns Hopkins ProHealth Research Center. All remaining meals and snacks were provided for participants to consume off-site. During the control diet, participants were instructed to continue their usual dietary intake. Relevant biomarkers and asthma clinical outcomes were assessed at 0, 2, and 4 weeks after starting each arm of the study.Eleven participants were randomized, and seven completed the full study protocol. Among these seven participants, average age was 42 years, six were female, and six were African American. Participant self-report of dietary intake revealed significant increases in fruit, vegetable, and omega-3 fatty acid intake with the dietary intervention compared to usual diet. Serum carotenoids (eg. lutein and beta-cryptoxanthin increased in the intervention versus control. Total cholesterol decreased in the intervention versus control diet. There was no consistent effect on asthma outcomes.The findings suggest that a feeding trial in participants with asthma is feasible. Larger trials are needed to definitively assess the potential benefits of dietary interventions on pulmonary symptoms and function in patients with asthma.

  4. Translation of Randomised Controlled Trial Findings into Clinical Practice : Comparison of Olanzapine and Valproate in the EMBLEM Study

    NARCIS (Netherlands)

    Novick, D.; Gonzalez-Pinto, A.; Haro, J. M.; Bertsch, J.; Reed, C.; Perrin, E.; Tohen, M.

    Objectives: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. Methods: EMBLEM (European Mania in Bipolar Evaluation of

  5. The Trial of Napoleon: A Case Study for Using Mock Trials.

    Science.gov (United States)

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  6. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  7. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine

    DEFF Research Database (Denmark)

    Ault, Kevin A; Joura, Elmar A; Kjaer, Susanne K

    2011-01-01

    The primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis......, and 6. Women underwent colposcopy and biopsy according to a Papanicolaou triage algorithm. All tissue specimens were tested for 14 HPV types and were adjudicated by a pathology panel. During the trials, 22 women were diagnosed with AIS (six vaccine and 16 placebo). There were 25 AIS lesions in total......, we include all women who had at least one follow-up visit postenrollment. Healthy women (17,622) aged 15-26 with no history of HPV disease and a lifetime number of less than five sex partners (average follow-up of 3.6 years) were randomized (1:1) to receive vaccine or placebo at day 1, months 2...

  8. Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Zarbock, Alexander; Gerß, Joachim; Van Aken, Hugo; Boanta, Andreea; Kellum, John A; Meersch, Melanie

    2016-03-18

    Acute kidney injury remains a common complication in critically ill patients and despite multiple trials and observational studies, the optimal timing for initiation of renal replacement therapy is still unclear. The early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN) study is a randomized, single-center, prospective, two-arm, parallel group trial to reduce mortality in patients with severe acute kidney injury. We describe the study design and discuss aspects of the need for a trial in this patient cohort. Our plan is to randomize critically ill patients with acute kidney injury to 'early' or 'late' initiation of renal replacement therapy according to stage 2 and 3 of the KDIGO classification using a specific trial protocol. We plan to guide data collection and analysis using pre-existing definitions and testing. The primary endpoint is overall survival in a 90-day follow-up period. Secondary endpoints include 28-day, 60-day, 90-day and 1-year all-cause mortality, recovery of renal function, ICU and hospital length-of-stay. The primary analysis will be an intention-to-treat analysis; secondary analyses include treated analyses. We will also specify rules for handling data and determining outcome. Several challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the practice of renal replacement therapy in critically ill patients with acute kidney injury. German Clinical Trials Register: DRKS00004367 ( www.germanctr.de ); 28 May 2013.

  9. [Effects of low calorie sweeteners based on data from clinical trials, in vitro and animal studies].

    Science.gov (United States)

    Szűcs, Zsuzsanna; Ábel, Tatjána; Lengyel, Gabriella

    2016-04-01

    Low calorie sweeteners are used by many consumers as they can provide the sweet taste without calories and, therefore, they may have a beneficial effect on weight management. These positive outcomes are often questioned and accused of keeping up or increasing a liking for sweetness and leading to overconsumption of sugar containing food and beverages. The most recent studies failed to find any positive correlation between usage of low calorie sweeteners and craving for sweet taste. In randomized controlled trials consumption of low calorie sweeteners have accompanied with lower intake of sugar containing food, higher healthy eating index and better weight management. Several laboratory trials on cell cultures and animal studies found a link between the usage of low calorie sweeteners and positive metabolic effects, e.g. smaller ectopic fat deposits in the fat and liver tissue versus controll group. In addition, increased adipogenesis and reduction of lipolysis were also observed. Orv. Hetil., 2016, 157(Suppl. 1), 3-7.

  10. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

    Science.gov (United States)

    Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A

    2017-12-02

    Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the

  11. Issues of reporting in observational studies in veterinary medicine.

    Science.gov (United States)

    Sargeant, Jan M; O'Connor, Annette M

    2014-02-15

    Observational studies are common in veterinary medicine; the results may be used to inform decision-making, future research, or as inputs to systematic reviews or risk assessment. To be of use, the results must be published, all of the outcomes that were assessed must be included in the publication, and the research (methods and results) must be reported in sufficient detail that the reader can evaluate the internal and external validity. In human healthcare, concerns about the completeness of reporting - and evidence that poor reporting is associated with study results - have led to the creation of reporting guidelines; these include the STROBE statement for observational studies. There is evidence from a limited body of research that there also are reporting inadequacies in veterinary observational studies. There are differences between human and veterinary observational studies that might be relevant to recommendations for reporting. Such differences include: the use of observational studies in animal populations for simultaneously estimating disease frequency and risk-factor identification; the distinction between the animal owners who consent to participate and the animals that are the study subjects; and the complexity of organizational levels inherent in animal research (in particular, for studies in livestock species). In veterinary medicine, it is common to have clustering within outcomes (due to animal grouping) and clustering of predictor variables. We argue that there is a compelling need for the scientific community involved in veterinary observational studies to use the STROBE statement, use an amended version of STROBE, or to develop and use reporting guidelines that are specific to veterinary medicine to improve reporting of these studies. Copyright © 2013 Elsevier B.V. All rights reserved.

  12. When to base clinical policies on observational versus randomized trial data.

    Science.gov (United States)

    Hornberger, J; Wrone, E

    1997-10-15

    Physicians must decide when the evidence is sufficient to adopt a new clinical policy. Analysis of large clinical and administrative databases is becoming an important source of evidence for changing clinical policies. Because such analysis cannot control for the effects of all potential confounding variables, physicians risk drawing the wrong conclusion about the cause-and-effect relation between a change in clinical policy and outcomes. Randomized studies offer protection against drawing a conclusion that would lead to adoption of an inferior policy. However, a randomized study may be difficult to justify because of the extra costs of collecting data for a randomized study and concerns that a study will not directly benefit the patients enrolled in the study. This article reviews the advantages and disadvantages of basing clinical policy on analysis of large databases compared with conducting a randomized study. A technique is described and illustrated for accessing the potential costs and benefits of conducting such a study. This type of analysis formed the basis for a physician-managed health care organization deciding to sponsor a randomized study among patients with end-stage renal disease as part of a quality-improvement initiative.

  13. Studying a disease with no home--lessons in trial recruitment from the PATCH II study.

    LENUS (Irish Health Repository)

    Thomas, Kim S

    2010-01-01

    Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients.

  14. SABRE observations of Pi2 pulsations: case studies

    Directory of Open Access Journals (Sweden)

    E. G. Bradshaw

    1997-01-01

    Full Text Available 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.

  15. Passive output feedback and observer based autopilots: A comparative study

    Directory of Open Access Journals (Sweden)

    Marit Paulsen

    1996-04-01

    Full Text Available Two methods for course-keeping of a ship are studied where no measurements of the yaw rate are available. The two methods are a passive output feedback controller and a controller-observer structure. A comparison with special attention to stability and wave filtering properties, is provided. Finally, a case study of a ship autopilot is included.

  16. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

    NARCIS (Netherlands)

    Madsen, M.B.; Skrede, S.; Bruun, T.; Arnell, P.; Rosén, A.; Nekludov, M.; Karlsson, Y.; Bergey, F.; Saccenti, E.; Martins dos Santos, V.A.P.; Perner, A.; Norrby-Teglund, A.; Hyldegaard, O.

    2018-01-01

    Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating

  17. Observation and execution of upper-limb movements as a tool for rehabilitation of motor deficits in paretic stroke patients: protocol of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ertelt Denis

    2012-06-01

    Full Text Available Abstract Background Evidence exist that motor observation activates the same cortical motor areas that are involved in the performance of the observed actions. The so called “mirror neuron system” has been proposed to be responsible for this phenomenon. We employ this neural system and its capability to re-enact stored motor representations as a tool for rehabilitating motor control. In our new neurorehabilitative schema (videotherapy we combine observation of daily actions with concomitant physical training of the observed actions focusing on the upper limbs. Following a pilot study in chronic patients in an ambulatory setting, we currently designed a new multicenter clinical study dedicated to patients in the sub-acute state after stroke using a home-based self-induced training. Within our protocol we assess 1 the capability of action observation to elicit rehabilitational effects in the motor system, and 2 the capacity of this schema to be performed by patients without assistance from a physiotherapist. The results of this study would be of high health and economical relevance. Methods/design A controlled, randomized, multicenter, paralleled, 6 month follow-up study will be conducted on three groups of patients: one group will be given the experimental treatment whereas the other two will participate in control treatments. All patients will undergo their usual rehabilitative treatment beside participation in the study. The experimental condition consists in the observation and immediate imitation of common daily hand and arm actions. The two parallel control groups are a placebo group and a group receiving usual rehabilitation without any trial-related treatment. Trial randomization is provided via external data management. The primary efficacy endpoint is the improvement of the experimental group in a standardized motor function test (Wolf Motor Function Test relative to control groups. Further assessments refer to subjective and

  18. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  19. The effects of humor therapy on nursing home residents measured using observational methods: the SMILE cluster randomized trial.

    Science.gov (United States)

    Low, Lee-Fay; Goodenough, Belinda; Fletcher, Jennifer; Xu, Kenny; Casey, Anne-Nicole; Chenoweth, Lynn; Fleming, Richard; Spitzer, Peter; Bell, Jean-Paul; Brodaty, Henry

    2014-08-01

    To evaluate the effects of humor therapy assessed using observational methods on agitation, engagement, positive behaviors, affect, and contentment. Single-blind cluster randomized controlled trial. A total of 35 Sydney nursing homes. All eligible residents within geographically defined areas within each nursing home were invited to participate. Professional "ElderClowns" provided 9 to 12 weekly humor therapy sessions, augmented by resident engagement by trained staff "LaughterBosses." Controls received usual care. The Behavior Engagement Affect Measure (BEAM) touchpad observational tool was used to capture real-time behavioral data. The tool assesses the duration in seconds of agitation, positive behavior toward others, engagement, and affect (angry, anxious, happy, neutral, sad). Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Over 26 weeks, in comparison with controls, the humor therapy group decreased in duration of high agitation (effect size = 0.168 and 0.129 at 13 and 26 weeks, respectively) and increased in duration of happiness (effect size = 0.4 and 0.236 at 13 and 26 weeks, respectively). We confirmed that humor therapy decreases agitation and also showed that it increases happiness. Researchers may consider evaluating impacts of nonpharmaceutical interventions on positive outcomes. Computer-assisted observational measures should be considered, particularly for residents with dementia and when the reliability of staff is uncertain. Copyright © 2014 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  20. Analysis of the radiation related morbidity observed in a randomized trial of neutron therapy for bladder cancer

    International Nuclear Information System (INIS)

    Duncan, W.; Williams, J.R.; Kerr, G.R.; Arnott, S.J.; Quilty, P.M.; Rodger, A.; MacDougall, R.H.; Jack, W.J.

    1986-01-01

    This report is an analysis of the morbidity in the bladder and bowel observed in a randomized trial of d(15)+Be neutrons versus megavoltage photons in the treatment of bladder cancer. Acute reactions in the bladder and bowel were significantly worse after photon therapy. Of the patients treated with photons 45.7% had severe reactions in the bladder compared with 10.6% after neutron therapy (p less than 0.001). Severe acute bowel reactions were observed in 8.5% of the patients after photon therapy compared with 3.8% after neutron therapy (p less than 0.05). Late reactions were significantly worse after neutrons. Severe late reactions in the bladder were seen in 58.5% of patients after neutron therapy and in 40.5% after photon therapy (p less than 0.05). In the bowel they were observed in 53.3% of patients after neutron therapy compared with 8% after photon therapy (p less than 0.0001). The disparity in the degree of early and late complications makes assessment of RBE values difficult. It is estimated that for bladder morbidity the RBE value, for photon dose fractions of 2.75 Gy, is less than 3.3 for early reactions and equal to 3.4 for late effects. The respective RBE values for early and late effects in the bowel are less than 3.4 and 3.8

  1. Could phase 3 medicine trials be tagged as pragmatic? A case study: The Salford COPD trial.

    Science.gov (United States)

    Dal-Ré, Rafael

    2018-02-01

    Randomized clinical trials (RCTs) can be classified as explanatory or pragmatic. Currently, explanatory and pragmatic are considered to be the extremes of a continuum: Many trials have some features of both explanatory and pragmatic RCTs. The Salford Chronic Obstructive Respiratory Disease (COPD) trial was an open-label phase 3 RCT assessing an experimental product (fluticasone furoate-vilanterol) vs usual care. The Salford investigators labelled it as "the world's first phase 3 pragmatic RCT" in COPD patients. The evaluation of the Salford trial by means of the PRECIS-2 tool, yielded a mix of both extremes (explanatory and pragmatic) with several of the 9 domains close to the explanatory extreme and few to the pragmatic one. A number of the features could not be considered as being minimal changes over usual clinical practice. Hence, it would be difficult to accept that the Salford COPD trial was a pragmatic RCT. In addition, all trial participants could have been subject to the Hawthorne effect. The scientific community needs to be rigorous enough when using certain terms related to RCT. It is clear that the Salford COPD trial had particular features-sharing some of explanatory phase 3 RCTs and some of pragmatic RCTs. This, however, is not enough to tag it as a "pragmatic" RCT providing "real-world" data. These words should not be used when referring to prelicensed RCT, unless they really describe how was the trial conducted and the type of data gathered-something that with the current clinical trial regulations will only occur in very rare circumstances. © 2017 John Wiley & Sons, Ltd.

  2. Empirical evidence of study design biases in randomized trials

    DEFF Research Database (Denmark)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma

    2016-01-01

    search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta......-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR ...) characteristic. Results: We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7...

  3. Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial

    Directory of Open Access Journals (Sweden)

    Alexander W Dromerick

    2015-04-01

    Full Text Available Introduction: 795,000 Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 hours of upper extremity therapy either immediately upon rehab admission, 2-3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test at one year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial.

  4. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial

    Science.gov (United States)

    Dromerick, Alexander W.; Edwardson, Matthew A.; Edwards, Dorothy F.; Giannetti, Margot L.; Barth, Jessica; Brady, Kathaleen P.; Chan, Evan; Tan, Ming T.; Tamboli, Irfan; Chia, Ruth; Orquiza, Michael; Padilla, Robert M.; Cheema, Amrita K.; Mapstone, Mark E.; Fiandaca, Massimo S.; Federoff, Howard J.; Newport, Elissa L.

    2015-01-01

    Introduction: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2–3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial. PMID

  5. Evaluation of the Quality of Reporting of Observational Studies in Otorhinolaryngology - Based on the STROBE Statement.

    Science.gov (United States)

    Hendriksma, Martine; Joosten, Michiel H M A; Peters, Jeroen P M; Grolman, Wilko; Stegeman, Inge

    2017-01-01

    Observational studies are the most frequently published studies in literature. When randomized controlled trials cannot be conducted because of ethical or practical considerations, an observational study design is the first choice. The STROBE Statement (STrengthening the Reporting of OBservational studies in Epidemiology) was developed to provide guidance on how to adequately report observational studies. The objectives were 1) to evaluate the quality of reporting of observational studies of otorhinolaryngologic literature using the STROBE Statement checklist, 2) to compare the quality of reporting of observational studies in the top 5 Ear, Nose, Throat (ENT) journals versus the top 5 general medical journals and 3) to formulate recommendations to improve adequate reporting of observational research in otorhinolaryngologic literature. The top 5 general medical journals and top 5 otorhinolaryngologic journals were selected based on their ISI Web of Knowledge impact factors. On August 3rd, 2015, we performed a PubMed search using different filters to retrieve observational articles from these journals. Studies were selected from 2010 to 2014 for the general medical journals and from 2015 for the ENT journals. We assessed all STROBE items to examine how many items were reported adequately for each journal type. The articles in the top 5 general medical journals (n = 11) reported a mean of 69.2% (95% confidence interval (CI): 65.8%-72.7%; median 70.6%), whereas the top 5 ENT journals (n = 29) reported a mean of 51.4% (95% CI: 47.7%-55.0%; median 50.0%). The two journal types reported STROBE items significantly different (p STROBE Statement.

  6. Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial.

    Science.gov (United States)

    Panagiotou, Orestis A; Befano, Brian L; Gonzalez, Paula; Rodríguez, Ana Cecilia; Herrero, Rolando; Schiller, John T; Kreimer, Aimée R; Schiffman, Mark; Hildesheim, Allan; Wilcox, Allen J; Wacholder, Sholom

    2015-09-07

    To examine the effect of the bivalent human papillomavirus (HPV) vaccine on miscarriage. Observational long term follow-up of a randomized, double blinded trial combined with an independent unvaccinated population based cohort. Single center study in Costa Rica. 7466 women in the trial and 2836 women in the unvaccinated cohort enrolled at the end of the randomized trial and in parallel with the observational trial component. Women in the trial were assigned to receive three doses of bivalent HPV vaccine (n=3727) or the control hepatitis A vaccine (n=3739). Crossover bivalent HPV vaccination occurred in the hepatitis A vaccine arm at the end of the trial. Women in the unvaccinated cohort received (n=2836) no vaccination. Risk of miscarriage, defined by the US Centers for Disease Control and Prevention as fetal loss within 20 weeks of gestation, in pregnancies exposed to bivalent HPV vaccination in less than 90 days and any time from vaccination compared with pregnancies exposed to hepatitis A vaccine and pregnancies in the unvaccinated cohort. Of 3394 pregnancies conceived at any time since bivalent HPV vaccination, 381 pregnancies were conceived less than 90 days from vaccination. Unexposed pregnancies comprised 2507 pregnancies conceived after hepatitis A vaccination and 720 conceived in the unvaccinated cohort. Miscarriages occurred in 451 (13.3%) of all exposed pregnancies, in 50 (13.1%) of the pregnancies conceived less than 90 days from bivalent HPV vaccination, and in 414 (12.8%) of the unexposed pregnancies, of which 316 (12.6%) were in the hepatitis A vaccine group and 98 (13.6%) in the unvaccinated cohort. The relative risk of miscarriage for pregnancies conceived less than 90 days from vaccination compared with all unexposed pregnancies was 1.02 (95% confidence interval 0.78 to 1.34, one sided P=0.436) in unadjusted analyses. Results were similar after adjusting for age at vaccination (relative risk 1.15, one sided P=0.17), age at conception (1.03, P=0

  7. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Barr, Colin; Marois, Maria; Sim, Ida; Schmid, Christopher H; Wilsey, Barth; Ward, Deborah; Duan, Naihua; Hays, Ron D; Selsky, Joshua; Servadio, Joseph; Schwartz, Marc; Dsouza, Clyde; Dhammi, Navjot; Holt, Zachary; Baquero, Victor; MacDonald, Scott; Jerant, Anthony; Sprinkle, Ron; Kravitz, Richard L

    2015-02-27

    Chronic pain is prevalent, costly, and clinically vexatious. Clinicians typically use a trial-and-error approach to treatment selection. Repeated crossover trials in a single patient (n-of-1 trials) may provide greater therapeutic precision. N-of-1 trials are the most direct way to estimate individual treatment effects and are useful in comparing the effectiveness and toxicity of different analgesic regimens. The goal of the PREEMPT study is to test the 'Trialist' mobile health smartphone app, which has been developed to make n-of-1 trials easier to accomplish, and to provide patients and clinicians with tools for individualizing treatments for chronic pain. A randomized controlled trial is being conducted to test the feasibility and effectiveness of the Trialist app. A total of 244 participants will be randomized to either the Trialist app intervention group (122 patients) or a usual care control group (122 patients). Patients assigned to the Trialist app will work with their clinicians to set up an n-of-1 trial comparing two pain regimens, selected from a menu of flexible options. The Trialist app provides treatment reminders and collects data entered daily by the patient on pain levels and treatment side effects. Upon completion of the n-of-1 trial, patients review results with their clinicians and develop a long-term treatment plan. The primary study outcome (comparing Trialist to usual care patients) is pain-related interference with daily functioning at 26 weeks. Trialist will allow patients and clinicians to conduct personalized n-of-1 trials. In prior studies, n-of-1 trials have been shown to encourage greater patient involvement with care, which has in turn been associated with better health outcomes. mHealth technology implemented using smartphones may offer an efficient means of facilitating n-of-1 trials so that more patients can benefit from this approach. ClinicalTrials.gov: NCT02116621 , first registered 15 April 2014.

  8. Assessing the quality of reporting of observational studies in cancer.

    Science.gov (United States)

    Papathanasiou, Afroditi A; Zintzaras, Elias

    2010-01-01

    The vast majority of epidemiological studies in cancer are observational. However, inadequate reporting of the published observational studies (OS) may restrict the generalizability and credibility of study results. The aim of this study was to evaluate the reporting quality of OS concerning cancer. PubMed was searched for systematic reviews (SRs) of OS involving cancer published from January 2008 through February 2009. The citations provided in the SRs were evaluated for their reporting quality according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement, a checklist of items that are considered essential for good reporting of OS. The evaluation was focused on 25 methodological items/sub-items. The effect of journals' ranking in quality of reporting was also evaluated. The search identified 244 eligible OS included in seven SRs. Nine items/sub-items were reported by more than 90% of studies and 16 items/sub-items were reported by more than 70%. Some essential methodological aspects of OS (such as matching, absolute risks, missing data and flow diagram) were underreported. Significant differences were found among the seven SRs in the majority of the items. High and lower ranked journals were different only in reporting of results estimates and precision. The quality of reporting in OS in cancer was considered satisfactory, although certain items were underreported. Further improvement of reporting may enhance the validity of observational research.

  9. An experimental and trial study on the second- generation MSTP

    Science.gov (United States)

    Xiao, Xiaojun; Yang, Liu; Zuo, Jian

    2004-04-01

    With the explosive growth of data services, SDH/SONET network, which is designed for voice traffic, is required to be optimized for data services. SDH-based Multi-Service Transport Platform (MSTP), which greatly improves the data capabilities of SDH networks, has been attracting much interest of vendors as well as network operators. As a leading operator in China, we have conducted a field trial study and extensive experiments on MSTP. In this paper, we present the results of our experiments. It is verified via extensive experiments that the products from some leading vendors conform to the standards. In addition, it is shown that the performance of the new value-added metro Ethernet services is highly satisfied, i.e., with tight QOS guarantees and flexible bandwidth that fits the user"s requirement exactly. We have also performed experiments for multi-vendors interoperability, and the results are highly satisfied, paving the way for large scale deployment of 2G MSTP. Our trial work showed MSTP can be used to optimize the existing metro networks, i.e., to improve the utilization of the fiber and the bandwidth that are used to carry the ADSL traffic and the IP traffic. In addition, MSTP presents a new array of opportunities for operators to increase their revenues.

  10. Family psychoeducation for major depressive disorder - study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Timmerby, Nina; Austin, Stephen F; Ussing, Kristian

    2016-01-01

    BACKGROUND: Major depressive disorder has been shown to affect many domains of family life including family functioning. Conversely, the influence of the family on the course of the depression, including the risk of relapse, is one reason for targeting the family in interventions. The few studies...... will investigate the effect of family psychoeducation compared to social support on the course of the illness in patients with major depressive disorder. METHOD/DESIGN: The study is designed as a dual center, two-armed, observer-blinded, randomized controlled trial. Relatives are randomized to participate in one...

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

    OpenAIRE

    Bastuji-Garin, Sylvie; Sbidian, Emilie; Gaudy-Marqueste, Caroline; Ferrat, Emilie; Roujeau, Jean-Claude; Richard, Marie-Aleth; Canoui-Poitrine, Florence; Bouwes Bavinck, Jan Nico; Coenraads, Pieter-Jan; Diepgen, T.L.; Elsner, Peter; Garcia-Doval, Ignacio; Grob, J.J.; Langan, Sinead; Naldi, L.

    2013-01-01

    textabstractBackground: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...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  13. A statistical study of ion frictional heating observed by EISCAT

    Directory of Open Access Journals (Sweden)

    J. A. Davies

    1997-11-01

    Full Text Available Results of a statistical survey of F-region ion frictional heating are presented, a survey which is based on over 4000 h of common programme observations taken by the European incoherent scatter (EISCAT UHF radar facility. The criterion adopted in this study for the identification of ion frictional heating was that defined by McCrea et al., requiring an enhancement in the F-region field-parallel ion temperature exceeding 100 K over two consecutive integration periods, which was itself based on a selection criterion for frictional heating derived for the study of high-latitude F-region ion temperature observations from the Atmospheric Explorer-C satellite. In the present study, the diurnal distribution of ion frictional heating observed by EISCAT is established and, furthermore, its dependence on geomagnetic activity and the orientation of the interplanetary magnetic field (IMF is investigated; results are interpreted with reference to corresponding distributions of enhanced ion velocity, again derived from the extended set of EISCAT UHF common programme observations. The radar, due to its location relative to the large-scale convection pattern, observes ion frictional heating principally during the night, although preferentially during the post-midnight hours where there is reduced coupling between the ion and neutral populations. There is an increased preponderance of frictional heating during intervals of high geomagnetic activity and for a southward z component of the IMF and, moreover, evidence of asymmetries introduced by the y component of the IMF.

  14. Extension Trial of Qigong for Fibromyalgia: A Quantitative and Qualitative Study

    OpenAIRE

    Sawynok, Jana; Lynch, Mary; Marcon, Dana

    2013-01-01

    This extension trial is an open-label observational trial of 20 subjects with fibromyalgia who undertook level 2 Chaoyi Fanhuan Qigong (CFQ) training following an earlier controlled trial of level 1 CFQ. Subjects practiced 60?min/day for 8 weeks and continued some daily practice for 6 months. Quantitative measures, assessed at baseline, 8 weeks, 4 and 6 months, were of pain, impact, sleep, physical and mental functions, and practice time. Qualitative comments also were recorded. Compared to b...

  15. Rapid Protective Effects of Early BCG on Neonatal Mortality Among Low Birth Weight Boys: Observations From Randomized Trials

    DEFF Research Database (Denmark)

    Biering-Sorensen, Sofie; Jensen, Kristoffer Jarlov; Monterio, Ivan

    2018-01-01

    Background. Three randomized trials (RCTs) in low-weight (....46–1.54]), but a significant reduction in weeks 2–4 (MRR = 0.56 [0.31–1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys. Discussion. The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance...... of providing BCG soon after birth. Trial registration numbers: ClinicalTrials.gov (NCT00146302) and ClinicalTrials.gov (NCT00625482)....

  16. [The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting of observational studies].

    Science.gov (United States)

    von Elm, E; Altman, D G; Egger, M; Pocock, S J; Gøtzsche, P C; Vandenbroucke, J P

    2008-06-01

    Much of biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

  17. OBSERVATIONS ON CLINICAL TREATMENT TRIALS OF INDUCED ESCHERICHIA COLI DIARRHOEA IN BUFFALO NEONATAL CALVES

    Directory of Open Access Journals (Sweden)

    M. T. Javed, A. Khan, Abid Hussain and Babar Niaz

    2000-01-01

    Full Text Available The study was conducted on 24 calves of one week-age, randomly divided into four groups, of six calves each. First three groups were experimentally infected with E. coli and given treatment in various combinations, while group four was taken as uninfected untreated control. Results obtained on different parameters were, green to yellow-white diarrhoea with variable consistency from watery to semisolid. Generally in all groups during first two days, calves passed faeces around 6-10 times a day and this frequency lowered in about 2-4 days. During first 3-4 days of treatment, all calves appeared weak, dull, depressed with cold skin and wetness of the muzzle, while oral mucosa was pale and eyes were sunken. Overall mean respiration rate of treatment groups was slower (P<0.05 than control group. However, pulse rate showed no difference between treatment and control group. Overall mean rectal temperature was lower (P<0.05 in calves treated with antibiotic alone and with antibiotic + electrolytes, while body weight was higher (P<0.05 in calves treated with antibiotic but was lower along with creatinine (P<0.05 in calves treated with antibiotic + electrolytes and those treated with electrolytes alone.

  18. Contribution of infrared observations to the study of supernovae remnants

    International Nuclear Information System (INIS)

    Douvion, Thomas

    2000-01-01

    This research thesis addresses the study of dust in young supernovae remnants observed in middle infrared, mainly by means of the ISOCAM instrument installed on the ISO satellite. The author first presents the supernovae physics and the studied young remnants, describes dusts and the main sites of formation and destruction, and outlines the difficulties and benefits of observations performed in the middle infrared. Then, the author reports acquired evidences related to the formation of dusts in supernovae, and the search for a millimetre emission by cold dust contained in regions which are not yet excited by the shock, in order to better assess the overall quantities created by supernovae. He reports the use of observations of dust and neon in Cassiopeia A to perform a diagnosis on the mixture of elements during the supernovae explosion [fr

  19. Effectiveness of psychotherapeutic consultation in the workplace: a controlled observational trial.

    Science.gov (United States)

    Rothermund, Eva; Gündel, Harald; Rottler, Edit; Hölzer, Michael; Mayer, Dorothea; Rieger, Monika; Kilian, Reinhold

    2016-08-26

    This study compares the effectiveness of psychotherapeutic consultation in the workplace (PSIW) with psychotherapeutic outpatient care (PSOC) in Germany. Work ability (WAI), quality of life (SF-12), clinical symptoms (PHQ) and work-related stress (MBI, IS) were assessed in 367 patients seeking mental health care via two routes (PSIW n = 174; PSOC n = 193) before consultation and 12 weeks later. Changes in outcome variables were assessed using covariance analysis with repeated measures (ANCOVA) with sociodemographic variables (propensity score method), therapy dose, setting and symptom severity as covariates. The PSIW and PSOC groups included 122 and 66 men respectively. There were 102 first-time users of mental healthcare in the PSIW group and 83 in the PSOC group. There were group differences in outcome variables at baseline (p effect of group on outcome variables and no group*time interaction. Work-related stress indicators did not change during the intervention, but work ability improved in both groups (F = 10.149, p = 0.002; baseline M = 27.2, SD = 8.85); follow-up M = 28.6, SD = 9.02), as did perceived mental health (SF-12 MCS), depression (PHQ-9) and anxiety (PHQ-7). Effect sizes were between η(2) = 0.028 and η(2) = 0.040. Psychotherapeutic consultation is similarly effective in improving patients' functional and clinical status whether delivered in the workplace or in an outpatient clinic. Offering mental health services in the workplace makes it easier to reach patients at an earlier stage in their illness and thus enables provision of early and effective mental health care. DRKS00003184 , retrospectively registered 13 January 2012.

  20. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  1. general paralysis in a tropical country. study of 43 observations

    African Journals Online (AJOL)

    GENERAL PARALYSIS IN A TROPICAL COUNTRY. STUDY OF 43 OBSERVATIONS. Amara Cisse, Yves Morel, Abass Fodé Cisse, Naby Camara, Bangaly Cisse, Morifode Doukoure, Ibrahima Sory Souare, Mariam Barry, Siaka Camara, Sele Kourouma, Mohamed Mmah Diaby, L Dasilva, Amara Sylla, Hasmiou Dia ...

  2. An observational study on the relationship between plasma vitamin ...

    African Journals Online (AJOL)

    Methods. In a prospective, observational study of 25 adult septic shock patients, serial blood samples were analysed for vitamin C, thiobarbituric acid-reactive substances (TBARS) (a biomarker of oxidative stress), and soluble vascular cell adhesion molecule-1 (sVCAM-1) and E-selectin. (markers of endothelial dysfunction).

  3. Serum YKL-40 and gestational diabetes - an observational cohort study

    DEFF Research Database (Denmark)

    Gybel-Brask, Dorte; Johansen, Julia S; Christiansen, Ib J

    2016-01-01

    To examine serum YKL-40 in women developing gestational diabetes mellitus (GDM). In the present large observational cohort study of 1179 pregnant women, we determined serum YKL-40 four times during pregnancy (at gestational age 12, 20, 25, and 32 weeks). Pregnancy outcome was obtained from medical...

  4. An observational study of defensible space in the neighbourhood park

    Science.gov (United States)

    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.

  5. Observing position and movements in hydrotherapy: a pilot study.

    Science.gov (United States)

    Stark, Mary Ann; Rudell, Barb; Haus, George

    2008-01-01

    To observe and describe the positions and movements women choose while immersed in water during the first stage of labor. Descriptive, observational pilot study. A rural community hospital that provided hydrotherapy in labor. Women (N = 7) who intended to use hydrotherapy in labor were recruited prenatally from a midwife-managed practice. For 15 minutes of each hour during the first stage of labor, position and movements of the participants were observed and recorded on a laptop computer. The observational tool was developed for this study from a review of the literature and interviews with nursing experts; 435 observations were recorded. Women were free to choose when and how long to use hydrotherapy and had no restriction on their positions and movements. Only 3 of the 7 participants labored in the tub. Women demonstrated a greater range of positions and movements in the tub than in bed, both throughout labor and during late first-stage labor (7-10 cm of dilatation). Women had more contractions and made more rhythmic movements while in the tub than in bed. Hydrotherapy may encourage upright positions and movements that facilitate labor progress and coping, helping women avoid unnecessary interventions.

  6. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial.

    Science.gov (United States)

    Stupica, Daša; Velušcek, Maša; Blagus, Rok; Bogovic, Petra; Rojko, Tereza; Cerar, Tjaša; Strle, Franc

    2018-01-29

    Several guidelines advocate the same treatment approaches for both early disseminated Lyme borreliosis, manifested as multiple erythema migrans (EM), and early localized Lyme borreliosis, manifested as solitary EM. Oral doxycycline (100 mg q12h) was compared on a non-inferiority premise with intravenous ceftriaxone (2 g q24h) for 14 days in 200 adult European patients with multiple EM in an open-label alternate-treatment observational trial performed in a single-centre university hospital. Treatment outcome was assessed at 14 days and at 2, 6 and 12 months post-enrolment. Non-specific symptoms in patients and 192 control subjects without a history of Lyme borreliosis were evaluated and compared. This trial was registered at http://clinicaltrials.gov (identifier NCT01163994). At the 12 month visit, 4/82 (4.9%) multiple EM patients prescribed doxycycline and 6/88 (6.8%) multiple EM patients prescribed ceftriaxone showed incomplete response manifested predominantly as post-Lyme symptoms (1.9% difference, upper limit of 95% CI 5.1%). The upper limit of 95% CI for the difference in proportion of patients with incomplete response between doxycycline and ceftriaxone groups did not exceed the predetermined non-inferiority margin of 10%. The frequency of non-specific symptoms in patients was similar to that in controls. The 14 day oral doxycycline was not inferior to the 14 day intravenous ceftriaxone in treatment of adult European patients with early disseminated Lyme borreliosis manifested as multiple EM. The frequency of non-specific symptoms in patients was similar to that in controls without a history of Lyme borreliosis. © The Author(s) 2018. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies

    Science.gov (United States)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma; Sterne, Jonathan A. C.; Hróbjartsson, Asbjørn; Savović, Jelena

    2016-01-01

    Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic review of meta-epidemiological studies. Methods We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome (“mortality” versus “other objective” versus “subjective”). Direction of effect was standardised so that ROR ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Conclusions Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. PMID:27398997

  8. Driving performance while using cell phones: an observational study.

    Science.gov (United States)

    Rosenbloom, Tova

    2006-01-01

    Through spontaneous driving observations, this study sought to examine the impact of using a hands-free cell phone while driving on speed and safe gap keeping behaviors. The study also examined the association between the measure of disturbance created by using a cell phone and the driver's awareness of the disturbance. Twenty-three male adults were observed while driving for an hour and a half each; drivers were unaware of being observed. During the session, each of the participants received a phone call, initiated by an associate of the observer. The experiment was divided into two periods during which the experimental parameters were monitored: 10 minutes during conversation on a cell phone and 10 minutes of non-conversation on a hands-free cell phone. After the experiment, the driver was questioned concerning the extent to which his/her driving was disturbed by the cell phone conversation. T-test for matched samples revealed that the gaps between the drivers' cars and those in front of them diminished when drivers were engaged in the cell phone conversations. Repeated measures ANOVA revealed that drivers that had short conversations did not change their speed, while drivers who were engaged in long (over 16 minutes) conversations drove faster. No effect of drivers' awareness toward cell phone-related disturbance on actual driving behavior monitored in the present study was found.

  9. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  10. Clinical Trials

    Science.gov (United States)

    ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  11. Pearls and perils of an implantable defibrillator trial using a common control: implications for the design of future studies

    Directory of Open Access Journals (Sweden)

    Hallstrom Alfred P

    2008-05-01

    Full Text Available Abstract Aims Implantable defibrillators are considered life-saving therapy in heart failure (CHF patients. Surprisingly, the recent Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT reached an opposing conclusion from that of numerous other trials about their survival benefit in patients with advanced CHF. A critical analysis of common control trial design may explain this paradoxical finding, with important implications for future studies. Methods and Results Common control trials compare several intervention groups to a single rather than separate control groups. Though potentially requiring fewer patients than trials using separate controls, variation in the common control group will influence all comparisons and creates correlations between findings. During subgroup analyses, this dependency of outcomes may increase belief in the presence of a real subgroup effect when, in fact, it should increase skepticism. For example, a high (r = 0.92, statistically unlikely (p = 0.052 correlation between comparisons was observed across the subgroups reported in SCD-HeFT. Such concordance between amiodarone and a defibrillator across subgroups was unexpected, given how much the effects of these treatments significantly differed from one another in the main study. This suggests the study's subgroup findings (specifically the absence of benefit from defibrillators in advanced CHF were not necessarily a consequence of treatment; more likely, they resulted from variation in what the treatments were compared against, the common control. Conclusion Common control trials can be more efficient than other designs, but induce dependence between treatment comparisons and require cautious interpretation.

  12. Trial of labour in twin pregnancies: a retrospective cohort study.

    Science.gov (United States)

    de Castro, H; Haas, J; Schiff, E; Sivan, E; Yinon, Y; Barzilay, E

    2016-05-01

    To assess the success rate of vaginal delivery among women with twin pregnancies; the Twin Birth Study has shown that vaginal delivery and caesarean section are equally safe for twin delivery but >40% of the planned vaginal delivery group delivered by caesarean section. A retrospective cohort study. A tertiary medical centre. A total of 2194 women with twin pregnancies not complicated with very low birthweight. Planned mode of delivery was documented in the woman's electronic record upon entering the delivery room. Information regarding maternal age at delivery, parity, gestational age, presentation, previous history of caesarean delivery, birthweight and Apgar score was collected from the obstetric electronic charts. Rate of vaginal twin delivery. Of the 2194 women included, 1311 twin pregnancies had planned caesarean delivery and 883 underwent a trial of labour. Of the 883 women who underwent a trial of labour, the rate of vaginal delivery was 86.9%, whereas the rates of caesarean delivery and combined vaginal-caesarean delivery were 11.1% and 2.0%, respectively. Presentation of second twin, gestational age and maternal age did affect the chances of success. Nulliparity [odds ratio (OR) 2.38, 95% confidence interval (95% CI) 1.4-4.05], Foley induction of labour (OR 2.33, 95% CI 1.38-3.91) and body mass index >30 kg/m(2) (OR 1.76, 95% CI 1.03-3) were independent risk factors for caesarean delivery. The rate of vaginal delivery among women with twin pregnancies who undergo labour can be high, especially in women who laboured spontaneously and have delivered before. The rate of vaginal delivery of twins can be high, especially in women who have delivered before. © 2015 Royal College of Obstetricians and Gynaecologists.

  13. Sample size for equivalence trials: a case study from a vaccine lot consistency trial.

    Science.gov (United States)

    Ganju, Jitendra; Izu, Allen; Anemona, Alessandra

    2008-08-30

    For some trials, simple but subtle assumptions can have a profound impact on the size of the trial. A case in point is a vaccine lot consistency (or equivalence) trial. Standard sample size formulas used for designing lot consistency trials rely on only one component of variation, namely, the variation in antibody titers within lots. The other component, the variation in the means of titers between lots, is assumed to be equal to zero. In reality, some amount of variation between lots, however small, will be present even under the best manufacturing practices. Using data from a published lot consistency trial, we demonstrate that when the between-lot variation is only 0.5 per cent of the total variation, the increase in the sample size is nearly 300 per cent when compared with the size assuming that the lots are identical. The increase in the sample size is so pronounced that in order to maintain power one is led to consider a less stringent criterion for demonstration of lot consistency. The appropriate sample size formula that is a function of both components of variation is provided. We also discuss the increase in the sample size due to correlated comparisons arising from three pairs of lots as a function of the between-lot variance.

  14. Are survival and mortality rates associated with recruitment to clinical trials in teenage and young adult patients with acute lymphoblastic leukaemia? A retrospective observational analysis in England.

    Science.gov (United States)

    Hough, Rachael; Sandhu, Sabrina; Khan, Maria; Moran, Anthony; Feltbower, Richard; Stiller, Charles; Stevens, Mike C G; Rowntree, Clare; Vora, Ajay; McCabe, Martin G

    2017-10-05

    Participation rates in clinical trials are low in teenagers and young adults (TYA) with cancer. Whilst the importance of clinical trials in informing best practice is well established, data regarding individual patient benefit are scarce. We have investigated the association between overall survival and trial recruitment in TYA patients with acute lymphoblastic leukaemia (ALL). Retrospective. National (England) TYA patients treated for ALL. 511 patients aged 15-24 years diagnosed with ALL between 2004 and 2010 inclusive, of whom 239 (46.7%) participated in the UKALL2003 trial. Patients were identified using National Clinical Trial (UKALL2003) and Cancer Registry (National Cancer Data Repository, English National Cancer Online Registration Environment) Databases. Relative survival rates were calculated for trial and non-trial patients and observed differences were modelled using a multiple regression approach. The numbers and percentages of deaths in those patients included in the survival analysis were determined for each 3-month period, p values were calculated using the two-tailed z-test for difference between proportions and 95% CIs for percentage deaths were derived using the binomial distribution based on the Wilson Score method. Patients treated on the trial had a 17.9% better 2-year survival (85.4% vs 67.5%, p<0.001) and 8.9% better 1-year survival (90.8% vs 81.9%, p=0.004) than those not on the trial. 35 (14.6%) patients recruited to the trial died in the 2 years following diagnosis compared with 86 (32.6%) of those not recruited (p<0.001). TYA patients recruited to the clinical trial UKALL 2003 in England had a lower risk of mortality and a higher overall survival than contemporaneous non-trial patients. These data underline the potential for individual patient benefit in participating in a clinical trial and the importance of international efforts to increase trial participation in the TYA age group. ISRCTN07355119. © Article author(s) (or their

  15. Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy.

    Science.gov (United States)

    Makharia, Govind K; Ghoshal, Uday C; Ramakrishna, Balakrishnan S; Agnihotri, Abhishek; Ahuja, Vineet; Chowdhury, Sudipta Dhar; Gupta, Siddhartha Datta; Mechenro, John; Mishra, Asha; Mishra, Asha; Pathak, Manish K; Pandey, Ravinder M; Sharma, Raju; Sharma, Surendra K

    2015-09-01

    The duration of treatment of gastrointestinal tuberculosis continues to be a matter of debate. The World Health Organization advocates intermittent directly observed short-course therapy (DOTs), but there is a lack of data of its efficacy in abdominal tuberculosis. We therefore conducted a multicenter randomized controlled trial to compare 6 months and 9 months of antituberculosis therapy using DOTs. One hundred ninety-seven patients with abdominal tuberculosis (gastrointestinal, 154; peritoneal, 40; mixed, 3) were randomized to receive 6 months (n = 104) or 9 months (n = 93) of antituberculosis therapy using intermittent directly observed therapy. Patients were followed up 1 year after completion of treatment to assess recurrence. Patients were evaluated for primary endpoint (complete clinical response, partial response, and no response) and secondary endpoint (recurrence of the disease at the end of 1 year of follow-up). Baseline characteristics were similar between the 2 randomized groups. There was no difference between the 6-month group and 9-month group in the complete clinical response rate on per-protocol analysis (91.5% vs 90.8%; P = .88) or intent-to-treat analysis (75% vs 75.8%; P = .89). Only 1 patient in the 9-month group and no patients in the 6-month group had recurrence of disease. Side effects occurred in 21 (21.3%) and 16 (18.2%) patients in the 6-month and 9-month groups, respectively. There was no difference in efficacy of antituberculosis therapy delivered for either 6 months or 9 months in either gastrointestinal or peritoneal tuberculosis, confirming the efficacy of intermittent directly observed therapy. NCT01124929. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  16. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies.

    Directory of Open Access Journals (Sweden)

    Matthew J Page

    Full Text Available To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.Systematic review of meta-epidemiological studies.We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012, and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR or difference in standardised mean differences (dSMD in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective". Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate characteristic.We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies. For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies, lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study. The influence of other characteristics (e.g. unblinded trial personnel, attrition is unclear.Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several

  17. [The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

    Science.gov (United States)

    Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

    2017-01-01

    In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

  18. Femoral component rotation in patellofemoral joint replacement: a study protocol for a prospective observational study.

    Science.gov (United States)

    Westerbeek, Robin E; Derks, Rosalie P H; Zonneveld, Bas J G L; van Jonbergen, Hans-Peter W

    2015-01-01

    Patellofemoral joint replacement is a successful treatment option for isolated patellofemoral osteoarthritis. The short and mid-term outcomes are related to malposition and unexplained pain. Whether external rotation of the femoral component in isolated patellofemoral joint replacement is required is unclear. The primary aim of this study is to determine the CT-measured femoral component rotation of patellofemoral joint replacement relative to the transepicondylar axis. The secondary aim is to correlate the CT-measured femoral component rotation with the clinical outcomes at 1-year follow-up as assessed with the KOOS questionnaire. We designed a prospective observational study with medical research ethics committee and institutional review board approval. A total of 40 patients who will be treated with patellofemoral joint replacement for isolated patellofemoral osteoarthritis will be included. Intra-operatively, rotation of the femoral component will be assessed using anatomical landmarks including the epicondylar axis, Whiteside's line, and lower leg axis. The aim is to insert the femoral component between 3 and 6 degrees external rotation relative to the transepicondylar axis. Two experienced musculoskeletal radiologists will measure the angle between the transepicondylar axis and the femoral component, two to three days after surgery. The primary outcome is the CT-based femoral component rotation of the prosthesis relative to the transepicondylar axis. The secondary outcome is the patient reported KOOS questionnaire at 1-year follow-up. Successful completion of this study will provide data on the actual amount of femoral component rotation in patellofemoral joint replacement, and its relationship with clinical results. (Netherlands Trial Register NTR4175).

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

    Science.gov (United States)

    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 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.

  20. Improving precision of forage yield trials: A case study

    Science.gov (United States)

    Field-based agronomic and genetic research relies heavily on the data generated from field evaluations. Therefore, it is imperative to optimize the precision of yield estimates in cultivar evaluation trials to make reliable selections. Experimental error in yield trials is sensitive to several facto...

  1. The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials

    Science.gov (United States)

    McCambridge, Jim; Kypri, Kypros; Bendtsen, Preben; Porter, John

    2013-01-01

    Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these kinds of ethical issues that can arise in research on public health interventions. PMID:24161181

  2. Physical function of the upper limb after breast cancer surgery. Results from the SOUND (Sentinel node vs. Observation after axillary Ultra-souND) trial.

    Science.gov (United States)

    Gentilini, O; Botteri, E; Dadda, P; Sangalli, C; Boccardo, C; Peradze, N; Ghisini, R; Galimberti, V; Veronesi, P; Luini, A; Cassano, E; Viale, G; Veronesi, U

    2016-05-01

    The SOUND (Sentinel node vs. Observation after axillary Ultra-souND) trial is an ongoing prospective randomized study comparing sentinel node biopsy vs. no axillary surgical staging in patients with small breast cancer and negative pre-operative ultra-sound of the axilla. The first 180 recruited patients were administered the QuickDASH (Disability Arm and Shoulder) questionnaire at different time points (before surgery, 1 week, 6 months and 1 year after surgery) to evaluate the physical function of the ipsilateral upper limb, The QuickDASH score ranges from 0 (no disability) to 100 (complete disability). 176 patients were available for analysis (94 in SNB arm and 82 in observation arm). The two groups were comparable with respect to age, tumor characteristics and treatments. Pre-surgery score values were 3.0% and 2.7% in the SNB arm and observation arm, respectively (P = 0.730). One week after surgery, the score increased to 24.0% in the SNB arm and 10.6% in the observation arm (P disability in the early post-operative period compared to patients who did not. The avoidance of SNB might translate into a considerable reduction of physical and emotional distress. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial.

    Science.gov (United States)

    Leef, George C; Hellkamp, Anne S; Patel, Manesh R; Becker, Richard C; Berkowitz, Scott D; Breithardt, Günter; Halperin, Jonathan L; Hankey, Graeme J; Hacke, Werner; Nessel, Christopher C; Singer, Daniel E; Fox, Keith A A; Mahaffey, Kenneth W; Piccini, Jonathan P

    2017-06-14

    Although implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting. Using data from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) (n=14 264), we compared baseline characteristics and clinical outcomes in patients with atrial fibrillation randomized to rivaroxaban versus warfarin who did and did not undergo CIED implantation or revision. In this post-hoc, postrandomization, on-treatment analysis, only the first intervention per patient was analyzed. During a median follow-up of 2.2 years, 453 patients (242 rivaroxaban group; 211 warfarin group) underwent de novo CIED implantation (64.2%) or revision procedures (35.8%). Patients who received CIEDs were older, more likely to be male, and more likely to have past myocardial infarction, but had similar stroke risk compared to patients who did not receive CIEDs. Most patients who received a device had study drug interrupted for the procedure and did not receive bridging anticoagulation. During the 30-day postprocedural period, 11 patients (4.55%) in the rivaroxaban group experienced bleeding complications compared with 15 (7.13%) in the warfarin group. Thromboembolic complications occurred in 3 patients (1.26%) in the rivaroxaban group and 1 (0.48%) in the warfarin group. Event rates were too low for formal hypothesis testing. Bleeding and thromboembolic events were low in both rivaroxaban- and warfarin-treated patients. Periprocedural use of oral factor Xa inhibitors in CIED implantation requires further study in prospective, randomized trials. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767. © 2017 The Authors, Bayer US LLC, and Janssen Research and Development. Published on behalf of the American Heart Association, Inc., by Wiley.

  4. Clinical Trials

    Medline Plus

    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  7. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. The results of this

  8. Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis.

    Science.gov (United States)

    Daniels, L; Ünlü, Ç; de Korte, N; van Dieren, S; Stockmann, H B; Vrouenraets, B C; Consten, E C; van der Hoeven, J A; Eijsbouts, Q A; Faneyte, I F; Bemelman, W A; Dijkgraaf, M G; Boermeester, M A

    2017-01-01

    Antibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis. Patients with CT-proven, primary, left-sided, uncomplicated, acute diverticulitis were included at 22 clinical sites in the Netherlands, and assigned randomly to an observational or antibiotic treatment strategy. The primary endpoint was time to recovery during 6 months of follow-up. Main secondary endpoints were readmission rate, complicated, ongoing and recurrent diverticulitis, sigmoid resection and mortality. Intention-to-treat and per-protocol analyses were done. A total of 528 patients were included. Median time to recovery was 14 (i.q.r. 6-35) days for the observational and 12 (7-30) days for the antibiotic treatment strategy, with a hazard ratio for recovery of 0·91 (lower limit of 1-sided 95 per cent c.i. 0·78; P = 0·151). No significant differences between the observation and antibiotic treatment groups were found for secondary endpoints: complicated diverticulitis (3·8 versus 2·6 per cent respectively; P = 0·377), ongoing diverticulitis (7·3 versus 4·1 per cent; P = 0·183), recurrent diverticulitis (3·4 versus 3·0 per cent; P = 0·494), sigmoid resection (3·8 versus 2·3 per cent; P = 0·323), readmission (17·6 versus 12·0 per cent; P = 0·148), adverse events (48·5 versus 54·5 per cent; P = 0·221) and mortality (1·1 versus 0·4 per cent; P = 0·432). Hospital stay was significantly shorter in the observation group (2 versus 3 days; P = 0·006). Per-protocol analyses were concordant with the intention-to-treat analyses. Observational treatment without antibiotics did not prolong recovery and can be considered appropriate in patients with uncomplicated diverticulitis. Registration number: NCT01111253 (http://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John

  9. Body Characteristics, Dietary Protein and Body Weight Regulation. Reconciling Conflicting Results from Intervention and Observational Studies?

    DEFF Research Database (Denmark)

    Ankarfeldt, Mikkel Z; Angquist, Lars; Stocks, Tanja

    2014-01-01

    into clinical trials. SUBJECTS/METHODS: Data were available from the European Diet, Obesity and Genes (DiOGenes) post-weight-loss weight-maintenance trial and the Danish Diet, Cancer and Health (DCH) cohort. Participants of the DCH cohort were matched with participants from the DiOGenes trial on gender, diet...... between greater protein intake and weight gain. In both types of studies the results are based on average weight changes, and show considerable diversity in both directions. This study investigates whether the discrepancy in the evidence could be due to recruitment of overweight and obese individuals......, and body characteristics. Different subsets of the DCH-participants, comparable with the trial participants, were analyzed for weight maintenance according to the randomization status (high or low protein) of the matched trial participants. RESULTS: Trial participants were generally heavier, had larger...

  10. Effective population management practices in diabetes care - an observational study

    DEFF Research Database (Denmark)

    Frølich, Anne; Bellows, Jim; Nielsen, Bo Friis

    2010-01-01

    Of fifteen diabetes care management practices, our data indicate that high performance is most associated with provider alerts and more weakly associated with action plans and with guideline distribution and training. Lack of convergence in the literature on effective care management practices su...... suggests that factors contributing to high performance may be highly context-dependent or that the factors involved may be too numerous or their implementation too nuanced to be reliably identified in observational studies....

  11. Strategies GeoCape Intelligent Observation Studies @ GSFC

    Science.gov (United States)

    Cappelaere, Pat; Frye, Stu; Moe, Karen; Mandl, Dan; LeMoigne, Jacqueline; Flatley, Tom; Geist, Alessandro

    2015-01-01

    This presentation provides information a summary of the tradeoff studies conducted for GeoCape by the GSFC team in terms of how to optimize GeoCape observation efficiency. Tradeoffs include total ground scheduling with simple priorities, ground scheduling with cloud forecast, ground scheduling with sub-area forecast, onboard scheduling with onboard cloud detection and smart onboard scheduling and onboard image processing. The tradeoffs considered optimzing cost, downlink bandwidth and total number of images acquired.

  12. Targeted Maximum Likelihood Estimation for Causal Inference in Observational Studies.

    Science.gov (United States)

    Schuler, Megan S; Rose, Sherri

    2017-01-01

    Estimation of causal effects using observational data continues to grow in popularity in the epidemiologic literature. While many applications of causal effect estimation use propensity score methods or G-computation, targeted maximum likelihood estimation (TMLE) is a well-established alternative method with desirable statistical properties. TMLE is a doubly robust maximum-likelihood-based approach that includes a secondary "targeting" step that optimizes the bias-variance tradeoff for the target parameter. Under standard causal assumptions, estimates can be interpreted as causal effects. Because TMLE has not been as widely implemented in epidemiologic research, we aim to provide an accessible presentation of TMLE for applied researchers. We give step-by-step instructions for using TMLE to estimate the average treatment effect in the context of an observational study. We discuss conceptual similarities and differences between TMLE and 2 common estimation approaches (G-computation and inverse probability weighting) and present findings on their relative performance using simulated data. Our simulation study compares methods under parametric regression misspecification; our results highlight TMLE's property of double robustness. Additionally, we discuss best practices for TMLE implementation, particularly the use of ensembled machine learning algorithms. Our simulation study demonstrates all methods using super learning, highlighting that incorporation of machine learning may outperform parametric regression in observational data settings. © The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  13. The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials

    Directory of Open Access Journals (Sweden)

    Platt Martin

    2010-05-01

    Full Text Available Abstract Background The subject of death and bereavement in the context of randomised controlled trials in neonatal or paediatric intensive care is under-researched. The objectives of this phase of the Bereavement and RAndomised ControlLEd Trials (BRACELET Study were to determine trial activity in UK neonatal and paediatric intensive care (2002-06; numbers of deaths before hospital discharge; and variation in mortality across intensive care units and trials and to determine whether bereavement support policies were available within trials. These are essential prerequisites to considering the implications of future policies and practice subsequent to bereavement following a child's enrolment in a trial. Methods The units survey involved neonatal units providing level 2 or 3 care, and paediatric units providing level II care or above; the trials survey involved trials where allocation was randomized and interventions were delivered to intensive care patients, or to parents but designed to affect patient outcomes. Results Information was available from 191/220 (87% neonatal units (149 level 2 or 3 care; and 28/32 (88% paediatric units. 90/177 (51% eligible responding units participated in one or more trial (76 neonatal, 14 paediatric and 54 neonatal units and 6 paediatric units witnessed at least one death. 50 trials were identified (36 neonatal, 14 paediatric. 3,137 babies were enrolled in neonatal trials, 210 children in paediatric trials. Deaths ranged 0-278 (median [IQR interquartile range] 2 [1, 14.5] per neonatal trial, 0-4 (median [IQR] 1 [0, 2.5] per paediatric trial. 534 (16% participants died post-enrolment: 522 (17% in neonatal trials, 12 (6% in paediatric trials. Trial participants ranged 1-236 (median [IQR] 21.5 [8, 39.8] per neonatal unit, 1-53 (median [IQR] 11.5 [2.3, 33.8] per paediatric unit. Deaths ranged 0-37 (median [IQR] 3.5 [0.3, 8.8] per neonatal unit, 0-7 (median [IQR] 0.5 [0, 1.8] per paediatric unit. Three trials had a

  14. A foundational observation method for studying design situations

    DEFF Research Database (Denmark)

    Cash, Philip; Hicks, Ben; Culley, Steve

    2015-01-01

    impact of individual studies is severely constrained. This paper begins to address this issue by introducing and developing a foundational method for observational design research to improve replicability, reuse, and overall comparability of empirical studies. A three-step foundational method is proposed...... that covers capture, coding, and analysis. The capture step defines overall and situational context as well as multiple capture streams, generating a broad data-set that can be examined from multiple perspectives. The coding step employs a multi-level approach that seeks to minimise workload while describing...

  15. Using data mining techniques to characterize participation in observational studies.

    Science.gov (United States)

    Linden, Ariel; Yarnold, Paul R

    2016-12-01

    Data mining techniques are gaining in popularity among health researchers for an array of purposes, such as improving diagnostic accuracy, identifying high-risk patients and extracting concepts from unstructured data. In this paper, we describe how these techniques can be applied to another area in the health research domain: identifying characteristics of individuals who do and do not choose to participate in observational studies. In contrast to randomized studies where individuals have no control over their treatment assignment, participants in observational studies self-select into the treatment arm and therefore have the potential to differ in their characteristics from those who elect not to participate. These differences may explain part, or all, of the difference in the observed outcome, making it crucial to assess whether there is differential participation based on observed characteristics. As compared to traditional approaches to this assessment, data mining offers a more precise understanding of these differences. To describe and illustrate the application of data mining in this domain, we use data from a primary care-based medical home pilot programme and compare the performance of commonly used classification approaches - logistic regression, support vector machines, random forests and classification tree analysis (CTA) - in correctly classifying participants and non-participants. We find that CTA is substantially more accurate than the other models. Moreover, unlike the other models, CTA offers transparency in its computational approach, ease of interpretation via the decision rules produced and provides statistical results familiar to health researchers. Beyond their application to research, data mining techniques could help administrators to identify new candidates for participation who may most benefit from the intervention. © 2016 John Wiley & Sons, Ltd.

  16. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  17. ‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

    OpenAIRE

    Daykin, Anne; Selman, Lucy E.; Cramer, Helen; McCann, Sharon; Shorter, Gillian W.; Sydes, Matthew R.; Gamble, Carrol; Macefield, Rhiannon; Lane, J. Athene; Shaw, Alison

    2017-01-01

    BackgroundThe oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder, and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines.MethodsUsing an ethnographic study design, we observed the oversight processes of eigh...

  18. Study of some defects observed in the hexagonal liquid crystals

    International Nuclear Information System (INIS)

    Oswald, Patrick

    1981-01-01

    A polarising microscopy study of the disclinations in an hexagonal discotic liquid crystal (hexa-pentoxy-triphenylene) allows us to confirm the theory of the developable domains and the existence of the disclinations as involute of the circle. The absence of the lines S = 1 leads us to propose a model of core in which the energetic instability of these lines is emphasized. The nature of the core is discussed: it is probably filled with hexagonal liquid crystal. Moreover the birefringence Δn is measured and a first estimate of the anchoring energies of the discotic both on the glass and in contact with the air is given. The Michelson interferometry study of the interaction between the disclinations and the free surface has allowed to observe a strong anisotropy of the interfacial tension. At last a study of the walls leads to a classification according to the matching angle and to a first estimate of the penetration distance λ. A similar study has been undertaken in an inverse middle liquid crystalline phase (Na dioctylsulfosuccinate). A strong dependence of the elastic constants with the water concentration is observed. The micellar → hexagonal transition is studied. (author) [fr

  19. Studying a disease with no home - lessons in trial recruitment from the PATCH II study

    Directory of Open Access Journals (Sweden)

    Thomas Kim S

    2010-03-01

    Full Text Available Abstract Background Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients. Methods A double-blind randomised controlled trial comparing prophylactic antibiotics (penicillin V with placebo tablets, for the prevention of repeat episodes of cellulitis of the leg. Primary outcome was time to subsequent recurrence of cellulitis. Results The PATCH II study was closed to recruitment having enrolled 123 participants from a target of 400. Whilst the recruitment period was extended by 12 months, it was not possible to continue beyond this point without additional funds. Many factors contributed to poor recruitment: (i changes in hospital policy and the introduction of community-based intravenous teams resulted in fewer cellulitis patients being admitted to hospital; ii those who were admitted were seen by many different specialties, making it difficult for a network of dermatology clinicians to identify suitable participants; and iii funding for research staff was limited to a trial manager and a trial administrator at the co-ordinating centre. With no dedicated research nurses at the recruiting centres, it was extremely difficult to maintain momentum and interest in the study. Attempts to boost recruitment by providing some financial support for principal investigators to employ local research staff was of limited success. Discussion The model of a network of busy NHS clinicians all recruiting a few patients into large clinical studies requires further testing. It did not work very well for PATCH II, but this was probably because patients were not routinely seen by dermatologists, and recruitment

  20. Improving recruitment to pharmacological trials for illicit opioid use: findings from a qualitative focus group study.

    Science.gov (United States)

    Neale, Joanne; Tompkins, Charlotte N E; McDonald, Rebecca; Strang, John

    2018-01-22

    To explore potential study participants' views on willingness to join clinical trials of pharmacological interventions for illicit opioid use to inform and improve future recruitment strategies. Qualitative focus group study [six groups: oral methadone (two groups); buprenorphine tablets (two groups); injectable opioid agonist treatment (one group); and former opioid agonist treatment (one group)]. Drug and alcohol services and a peer support recovery service (London, UK). Forty people with experience of opioid agonist treatment for heroin dependence (26 males, 14 females; aged 33-66 years). Data collection was facilitated by a topic guide that explored willingness to enrol in clinical pharmacological trials. Groups were audio-recorded and transcribed. Transcribed data were analysed inductively via Iterative Categorization. Participants' willingness to join pharmacological trials of medications for opioid dependence was affected by factors relating to study burden, study drug, study design, study population and study relationships. Participants worried that the trial drug might be worse than, or interfere with, their current treatment. They also misunderstood aspects of trial design despite the researchers' explanations. Recruitment of participants for clinical trials of pharmacological interventions for illicit opioid use could be improved if researchers became better at explaining clinical trials to potential participants, dispelling misconceptions about trials and increasing trust in the research process and research establishment. A checklist of issues to consider when designing pharmacological trials for illicit opioid use is proposed. © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  1. Observations of radiographer communication: An exploratory study using Transactional Analysis

    International Nuclear Information System (INIS)

    Booth, Lisa A.; Manning, David J.

    2006-01-01

    Purpose: Communication in medical imaging is a neglected area of research, despite the necessity for good communication if optimum diagnostic images are to be achieved. Methods: The present study has investigated the styles of communication used in medical imaging, using an approach known as Transactional Analysis. This approach has been demonstrated previously as having reliability and validity, using observations and supporting interviews with medical imaging staff, along with inter-rater observations of radiographer-patient interactions. Results: The results indicate that Transactional Analysis can be used effectively for identifying and naming interaction events in diagnostic radiography, with diagnostic radiographers using five styles of communication. Conclusion: Radiographers tend to use Parental styles of communicating; these styles are commonly associated with a practitioner-centred approach to dealing with patients which often result in non-adherence

  2. Linking Indigenous Knowledge and Observed Climate Change Studies

    Science.gov (United States)

    Alexander, Chief Clarence; Bynum, Nora; Johnson, Liz; King, Ursula; Mustonen, Tero; Neofotis, Peter; Oettle, Noel; Rosenzweig, Cynthia; Sakakibara, Chie; Shadrin, Chief Vyacheslav; hide

    2010-01-01

    We present indigenous knowledge narratives and explore their connections to documented temperature and other climate changes and observed climate change impact studies. We then propose a framework for enhancing integration of these indigenous narratives of observed climate change with global assessments. Our aim is to contribute to the thoughtful and respectful integration of indigenous knowledge with scientific data and analysis, so that this rich body of knowledge can inform science, and so that indigenous and traditional peoples can use the tools and methods of science for the benefit of their communities if they choose to do so. Enhancing ways of understanding such connections are critical as the Intergovernmental Panel on Climate Change Fifth Assessment process gets underway.

  3. Supplementing Oscat winds with Saral Altika observations for cyclone studies

    Science.gov (United States)

    Niharika, K.; Usha Sundari, H. S. V.; Prasad, A. V. V.; Kumari, E. V. S. Sita; Dadhwal, V. K.; Ali, M. M.

    2014-11-01

    Accurate prediction of life cycle of cyclone is very critical to the disaster management practices. Since the cyclones originate over the oceans where in situ observations are limited, we have to resort to the remote sensing techniques. Both optical and microwave sensors help studying the cyclones. While scatterometer provide wind vectors, altimeters can give only wind speed. In this paper we present how altimeter measurements can supplement the scatterometer observations in determining the radius of maximum winds (RMW). Sustained maximum winds, indicator for the intensity of the cyclone, are within the eye wall of a cyclone at a distance of RMW. This parameter is also useful in predicting right time of the storm surge. In this paper we used the wind speed estimations from AltiKa, an altimeter operating at Ka band.

  4. A Randomized Controlled Study of Art Observation Training to Improve Medical Student Ophthalmology Skills.

    Science.gov (United States)

    Gurwin, Jaclyn; Revere, Karen E; Niepold, Suzannah; Bassett, Barbara; Mitchell, Rebecca; Davidson, Stephanie; DeLisser, Horace; Binenbaum, Gil

    2018-01-01

    Observation and description are critical to the practice of medicine, and to ophthalmology in particular. However, medical education does not provide explicit training in these areas, and medical students are often criticized for deficiencies in these skills. We sought to evaluate the effects of formal observation training in the visual arts on the general and ophthalmologic observational skills of medical students. Randomized, single-masked, controlled trial. Thirty-six first-year medical students, randomized 1:1 into art-training and control groups. Students in the art-training group were taught by professional art educators at the Philadelphia Museum of Art, during 6 custom-designed, 1.5-hour art observation sessions over a 3-month period. All subjects completed pre- and posttesting, in which they described works of art, retinal pathology images, and external photographs of eye diseases. Grading of written descriptions for observational and descriptive abilities by reviewers using an a priori rubric and masked to group assignment and pretesting/posttesting status. Observational skills, as measured by description testing, improved significantly in the training group (mean change +19.1 points) compared with the control group (mean change -13.5 points), P = 0.001. There were significant improvements in the training vs. control group for each of the test subscores. In a poststudy questionnaire, students reported applying the skills they learned in the museum in clinically meaningful ways at medical school. Art observation training for first-year medical students can improve clinical ophthalmology observational skills. Principles from the field of visual arts, which is reputed to excel in teaching observation and descriptive abilities, can be successfully applied to medical training. Further studies can examine the impact of such training on clinical care. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  5. Physical activity as an aid to smoking cessation during pregnancy (LEAP trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ussher Michael

    2012-10-01

    Full Text Available Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy, and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations. The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for

  6. Primary Trauma Triage Performed by Bystanders: An Observation Study.

    Science.gov (United States)

    Nordberg, Martin; Castrén, Maaret; Lindström, Veronica

    2016-08-01

    The aim of this study was to evaluate whether bystanders with no training in triage can correctly prioritize three injured patients by using a triage instrument. An observational study was conducted. Participants performed a primary triage on three paper-based patient cases and answered 11 questions during a public event in the center of Stockholm, Sweden. A total of 69 persons participated in the study. The success rate among all the participants for correct triage of the three patient cases was 52 percent. The female participants and younger participants (triage to a greater extent. The over-triage was 12.5 percent and under-triage was 6.3 percent. Participants with no prior knowledge of triage instruments may be capable of triaging injured patients with the help of an easy triage instrument. The over- and under-triage percentages were low, and this may indicate that the developed triage instrument is relatively easy to use. It may also indicate that bystanders can identify a severely injured patient. Nordberg M , Castrén M , Lindström V . Primary trauma triage performed by bystanders: an observation study. Prehosp Disaster Med. 2016;31(4):353-357.

  7. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial

    Directory of Open Access Journals (Sweden)

    2007-10-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in many developed countries. Rates in other parts of the world vary widely. A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings. Design CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan. Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision. Five comparisons will be carried out in one trial, using a 2 × 2 × 2 × 2 × 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are: • Blunt versus sharp abdominal entry • Exteriorisation of the uterus for repair versus intra-abdominal repair • Single versus double layer closure of the uterus • Closure versus non-closure of the peritoneum (pelvic and parietal • Chromic catgut versus Polyglactin-910 for uterine repair The primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis or further operative procedures; or blood transfusion. The sample size required is 15,000 women in total; at least 7,586 women

  8. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  9. Critical illness outcome study: an observational study of protocols and mortality in intensive care units

    Directory of Open Access Journals (Sweden)

    Sevransky J

    2011-09-01

    Full Text Available Naeem A Ali1, David Gutteridge2, Sajid Shahul3, William Checkley4, Jonathan Sevransky4, Greg S Martin2 1The Ohio State University Medical Center, Columbus, OH; 2Emory University, Atlanta, GA; 3Beth Israel Deaconess Medical Center, Boston, MA; 4Johns Hopkins University, Baltimore, MD, USA Abstract: Individual intensive care unit (ICU characteristics including staffing, expertise, continuity, and team structure, have been associated with patient outcomes. Separately, some aspects of care in ICUs have been implemented through treatment protocols. The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS was designed to determine whether the extent of protocol use in ICUs is associated with hospital survival in a large number of US ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS steering committee. USCIITG-CIOS is a prospective, observational, ecological, multicentered study of mixed ICUs in the US. The data to be collected include organizational information for the ICU (eg, protocol availability and utilization, multidisciplinary staffing assessment, and patient level information (eg, demographics, acute and chronic medical conditions. The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high-protocol and low-protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize multivariable regression approaches to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. We anticipate at least 60 ICUs participating in USCIITG-CIOS to enroll approximately 6000 study subjects. USCIITG-CIOS is a multicenter study

  10. Clinical Trials

    Medline Plus

    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  11. [The reporting of observational studies: analysis using the STROBE statement].

    Science.gov (United States)

    Galera Llorca, Jordi; Lahoz Grillo, Raquel; Roig Loscertales, Francesc

    2011-12-01

    Deficiencies detected in biomedical studies publication different Guidelines to improve. The objective of the study is to assess the communication of observational studies of Cardiovascular and Metabolism therapeutic area (CVM) published in 6 Spanish journals in 2009 using the STROBE statement. Cross-sectional analysis of articles related to CVM therapeutic area, published during 2009 in 6 Spanish journals applying the 34 items of the STROBE statement. Descriptive analysis of the results for qualitative variables was performed using a frequency analysis. Quantitative variables were analyzed by sample estimates and dispersion. A comparative analysis of journals was performed using ANOVA with a statistical significance of pSTROBE recommendations. The Methods and Results sections showed more deficiencies.

  12. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

    DEFF Research Database (Denmark)

    Madsen, M. B.; Skrede, S.; Bruun, T.

    2018-01-01

    Indicator for Necrotizing Fasciitis (LRINEC) score and 90-day mortality; 90-day mortality in patients with and without acute kidney injury (AKI) and LRINEC score of six and above or below six; and association between affected body part at arrival and microbiological findings. Exploratory outcomes include......Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating...... univariate analyses of baseline characteristics associations with 90-day mortality. The statistical analyses will be conducted in accordance with the predefined statistical analysis plan. Conclusion: Necrotizing soft tissue infections result in severe morbidity and mortality. The INFECT study...

  13. Palliative care team visits. Qualitative study through participant observation

    Science.gov (United States)

    Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

    2016-01-01

    Objectives: To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. Methods: A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. Results: The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Conclusion: Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources. PMID:27226663

  14. Motorcycle helmet use in Southern China: an observational study.

    Science.gov (United States)

    Li, Gong-Li; Li, Li-Ping; Cai, Qi-En

    2008-06-01

    In China, despite national motorcycle helmet legislation and the known safety benefits of helmets, helmet use remains low. The aim of this study was to determine the rate of motorcycle helmet use and attitudes towards helmet use among drivers and passengers in two cities in Southern China to provide baseline data and scientific evidence for the formulation of an intervention aimed at strengthening road safety law enforcement. Observational sites were randomly selected from three road types (national roads, main streets, and subordinate streets). Observations were conducted during six specified time periods and uniform checklists were used to record helmet use. Motorcycle riders were randomly selected from service stations, elementary schools, and supermarket car parks to participate in a face-to-face interview to ascertain attitudes. Overall, the rate of correct helmet use among drivers was higher in Chaozhou (34.6%) than in Shantou (30.2%; P helmet use was higher among drivers in main streets, during daytime hours, and during weekdays (P helmet knowledge of motorcycle drivers was high with most reporting that helmets prevent or reduce head injury (Shantou: 78.2%; Chaozhou 70.6%). Although level of awareness of the benefits of helmets was high, observed helmet usage was low. These results suggest that there is a need to implement new interventions to increase helmet use.

  15. A Statistical Study of Interplanetary Type II Bursts: STEREO Observations

    Science.gov (United States)

    Krupar, V.; Eastwood, J. P.; Magdalenic, J.; Gopalswamy, N.; Kruparova, O.; Szabo, A.

    2017-12-01

    Coronal mass ejections (CMEs) are the primary cause of the most severe and disruptive space weather events such as solar energetic particle (SEP) events and geomagnetic storms at Earth. Interplanetary type II bursts are generated via the plasma emission mechanism by energetic electrons accelerated at CME-driven shock waves and hence identify CMEs that potentially cause space weather impact. As CMEs propagate outward from the Sun, radio emissions are generated at progressively at lower frequencies corresponding to a decreasing ambient solar wind plasma density. We have performed a statistical study of 153 interplanetary type II bursts observed by the two STEREO spacecraft between March 2008 and August 2014. These events have been correlated with manually-identified CMEs contained in the Heliospheric Cataloguing, Analysis and Techniques Service (HELCATS) catalogue. Our results confirm that faster CMEs are more likely to produce interplanetary type II radio bursts. We have compared observed frequency drifts with white-light observations to estimate angular deviations of type II burst propagation directions from radial. We have found that interplanetary type II bursts preferably arise from CME flanks. Finally, we discuss a visibility of radio emissions in relation to the CME propagation direction.

  16. How safe do teenagers behave on Facebook? An observational study.

    Directory of Open Access Journals (Sweden)

    Ellen Vanderhoven

    Full Text Available The substantial use of social network sites by teenagers has raised concerns about privacy and security. Previous research about behavior on social network sites was mostly based on surveys and interviews. Observational research overcomes problems inherent to this research method, for example social desirability. However, existing observational research mostly focuses on public profiles of young adults. Therefore, the current observation-study includes 1050 public and non-public Facebook-profiles of teenagers (13-18 to investigate (1 what kind of information teenagers post on their profile, (2 to what extent they protect this information using privacy-settings and (3 how much risky information they have on their profile. It was found that young people mostly post pictures, interests and some basic personal information on their profile. Some of them manage their privacy-settings as such that this information is reserved for friends' eyes only, but a lot of information is accessible on the friends-of-friends' pages. Although general risk scores are rather low, more detailed analyses show that teenagers nevertheless post a significant amount of risky information. Moreover, older teenagers and girls post more (risky information while there are no differences in applying privacy settings. We found no differences in the Facebook behavior of teenagers enrolled in different education forms. Implications of these results are discussed.

  17. How safe do teenagers behave on Facebook? An observational study.

    Science.gov (United States)

    Vanderhoven, Ellen; Schellens, Tammy; Valcke, Martin; Raes, Annelies

    2014-01-01

    The substantial use of social network sites by teenagers has raised concerns about privacy and security. Previous research about behavior on social network sites was mostly based on surveys and interviews. Observational research overcomes problems inherent to this research method, for example social desirability. However, existing observational research mostly focuses on public profiles of young adults. Therefore, the current observation-study includes 1050 public and non-public Facebook-profiles of teenagers (13-18) to investigate (1) what kind of information teenagers post on their profile, (2) to what extent they protect this information using privacy-settings and (3) how much risky information they have on their profile. It was found that young people mostly post pictures, interests and some basic personal information on their profile. Some of them manage their privacy-settings as such that this information is reserved for friends' eyes only, but a lot of information is accessible on the friends-of-friends' pages. Although general risk scores are rather low, more detailed analyses show that teenagers nevertheless post a significant amount of risky information. Moreover, older teenagers and girls post more (risky) information while there are no differences in applying privacy settings. We found no differences in the Facebook behavior of teenagers enrolled in different education forms. Implications of these results are discussed.

  18. A conceptual framework for evaluating data suitability for observational studies.

    Science.gov (United States)

    Shang, Ning; Weng, Chunhua; Hripcsak, George

    2017-09-08

    To contribute a conceptual framework for evaluating data suitability to satisfy the research needs of observational studies. Suitability considerations were derived from a systematic literature review on researchers' common data needs in observational studies and a scoping review on frequent clinical database design considerations, and were harmonized to construct a suitability conceptual framework using a bottom-up approach. The relationships among the suitability categories are explored from the perspective of 4 facets of data: intrinsic, contextual, representational, and accessible. A web-based national survey of domain experts was conducted to validate the framework. Data suitability for observational studies hinges on the following key categories: Explicitness of Policy and Data Governance, Relevance, Availability of Descriptive Metadata and Provenance Documentation, Usability, and Quality. We describe 16 measures and 33 sub-measures. The survey uncovered the relevance of all categories, with a 5-point Likert importance score of 3.9 ± 1.0 for Explicitness of Policy and Data Governance, 4.1 ± 1.0 for Relevance, 3.9 ± 0.9 for Availability of Descriptive Metadata and Provenance Documentation, 4.2 ± 1.0 for Usability, and 4.0 ± 0.9 for Quality. The suitability framework evaluates a clinical data source's fitness for research use. Its construction reflects both researchers' points of view and data custodians' design features. The feedback from domain experts rated Usability, Relevance, and Quality categories as the most important considerations. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  19. Nursing praxis, compassionate caring and interpersonal relations: an observational study.

    Science.gov (United States)

    Fry, Margaret; MacGregor, Casimir; Ruperto, Kate; Jarrett, Kate; Wheeler, Janet; Fong, Jacqueline; Fetchet, Wendy

    2013-05-01

    The Clinical Initiative Nurse (CIN) is a role that requires experienced emergency nurses to assess, initiate diagnostic tests, treat and manage a range of patient conditions. The CIN role is focused on the waiting room and to 'communicate the wait', initiate diagnostics or treatment and follow-up for waiting room patients. We aim to explore what emergency nurses' do in their extended practice role in observable everyday life in the emergency department (ED). The paper argues that compassionate caring is a core nursing skill that supports CIN interpersonal relations, despite the role's highly clinical nature. Sixteen non-participant observations were undertaken in three EDs in New South Wales, Australia. Nurses were eligible for inclusion if they had two years of emergency experience and had worked in the CIN role for more than one year. All CIN's that were observed were highly experienced with a minimum three year ED experience. The CIN observations revealed how compassionate caring was utilised by CIN's to quickly build a therapeutic relationship with patients and colleagues, and helped to facilitate core communication and interpersonal skills. While the CIN role was viewed as extended practice, the role relied heavily on compassionate care to support interpersonal relationships and to actualise extended practice care. The study supports the contribution made by emergency nurses and demonstrates how compassionate caring is central to nursing praxis. This paper also demonstrates that the CIN role utilises a complex mix between advanced clinical skills and compassion that supports interpersonal and therapeutic relationships. Further research is needed to understand how compassionate care can be optimised within nursing praxis and the duty of care between nurses and patients, nurses and other health care professionals so that future healthcare goals can be realised. Copyright © 2013 College of Emergency Nursing Australasia Ltd. All rights reserved.

  20. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

    2015-03-08

    Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy

  1. Suspected ventilator-associated respiratory infection in severely ill patients: a prospective observational study.

    Science.gov (United States)

    Shahin, Jason; Bielinski, Michael; Guichon, Celine; Flemming, Catherine; Kristof, Arnold S

    2013-10-22

    Ventilator-associated respiratory infection (VARI) is an important cause of morbidity in critically-ill patients. Clinical trials performed in heterogeneous populations have suggested there are limited benefits from invasive diagnostic testing to identify patients at risk or to target antimicrobial therapy. However, multiple patient subgroups (for example, immunocompromised, antibiotic-treated) have traditionally been excluded from randomization. We hypothesized that a prospective surveillance study would better identify patients with suspected VARI (sVARI) at high risk for adverse clinical outcomes, and who might be specifically targeted in future trials. We performed a prospective observational study in all patients ventilated for greater than 48 hours. sVARI was identified by surveillance for changes in white blood cell count, temperature, sputum, and/or new chest X-ray infiltrates. Indices of disease co-morbidity, as well as mortality, duration of mechanical ventilation, and length of hospital or ICU stay were correlated with sVARI. Of 1806 patients admitted to the ICU over 14 months, 267 were ventilated for greater than 48 hours, and 77 developed sVARI. Incidence of sVARI was associated with iatrogenic immunosuppression or admission for respiratory illness. Any sVARI, whether suspected ventilator-associated pneumonia (sVAP) or ventilator-associated tracheobronchitis (sVAT), was associated with increased length of stay and duration of mechanical ventilation. Clinical surveillance for sVARI identifies patients at risk for increased morbidity. Iatrogenically immunosuppressed patients, a subgroup previously excluded from randomized clinical trials, represent a growing proportion of the critically-ill at risk for sVARI who might be targeted for future investigations on diagnostic or therapeutic modalities.

  2. Defining safe criteria to diagnose miscarriage: prospective observational multicentre study

    Science.gov (United States)

    Preisler, Jessica; Kopeika, Julia; Ismail, Laure; Vathanan, Veluppillai; Farren, Jessica; Abdallah, Yazan; Battacharjee, Parijat; Van Holsbeke, Caroline; Bottomley, Cecilia; Gould, Deborah; Johnson, Susanne; Stalder, Catriona; Van Calster, Ben; Hamilton, Judith; Timmerman, Dirk

    2015-01-01

    Objectives To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.) Design Prospective multicentre observational trial. Setting Seven hospital based early pregnancy assessment units in the United Kingdom. Participants 2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm. Main outcome measures Mean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks’ gestation. Results The following indicated a miscarriage at initial scan: mean gestational sac diameter ≥25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ≥7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ≥18 mm for gestational sacs without an embryo presenting after 70 days’ gestation (907/907 specificity: 100%, 99.6% to

  3. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    Science.gov (United States)

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due

  4. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study.

    Science.gov (United States)

    O'Cathain, Alicia; Goode, Jackie; Drabble, Sarah J; Thomas, Kate J; Rudolph, Anne; Hewison, Jenny

    2014-06-09

    Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In 'the peripheral' model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In 'the add-on' model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally 'the integral' model played out in two ways. In 'integral-in-theory' studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In 'integral-in-practice' studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research

  5. Observational study of Arctium lappa in the treatment of acne vulgaris.

    Science.gov (United States)

    Miglani, Anjali; Manchanda, Raj K

    2014-07-01

    Arctium lappa (Lappa) is used in traditional Western and Chinese medicine for acne. It is mentioned in homeopathic literature for acne, but its effect has not previously been evaluated. To determine the effectiveness of homeopathic medicine Lappa in treatment of acne vulgaris. An uncontrolled observational interventional study was conducted on human subjects who fulfilled the inclusion criteria and gave written informed consent. Lappa was prescribed in potencies starting from 6c rising to 1M as required, over a period of 6 months. Objective assessment was change in acne lesion counts supplemented with Global Acne Grading System (GAGS) and subjective assessment by using Acne-Specific Quality of Life questionnaire (Acne-QoL). Out of 34 human subjects, 32 completed the follow-up. Statistical significant results were seen in lesion counts, GAGS and Acne-QoL score (p value Lappa has shown positive effects in the treatment of acne especially of inflammatory type. Further controlled, randomized studies with larger sample size are desirable. Trial is registered at ClinicalTrials.gov Identifier: NCT01040390. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  6. Conifer Green Needle Complex in Patients with Precancerous Gastric Lesions: An Observational Pilot Study

    Directory of Open Access Journals (Sweden)

    Vladimir Bespalov

    2016-01-01

    Full Text Available Objectives. Helicobacter pylori infection is common and can lead to precancerous gastric lesions. Standard antibiotic therapy has a failure rate of more than 25% from antibiotic resistance. The primary aim of this observational pilot study was to test the feasibility of a large-scale clinical trial of Conifer Green Needle Complex (CGNC to treat precancerous gastric lesions. Secondary aims were to investigate H. pylori infection, stomach function, and histopathology of the gastric mucosa. Methods. A tablet form of CGNC (extracted from Pinus sylvestris and Picea abies (L Karst was prescribed to 26 patients with precancerous gastric lesions (two tablets, 100 mg CGNC/tablet, three times per day for six months. Another 24 patients received no treatment. Results. Compared with control patients, CGNC-treated patients showed total or partial regression (using the quantitative Rome III diagnostic criteria of dyspeptic symptoms (92.3%, p<0.0001, eradication of H. pylori infection (57.1%, p<0.03, a reduction in endoscopic signs of gastritis (92.3%, p<0.001, an increase of pepsinogen-pepsin in the gastric juice (57.7%, p<0.05, and total regression or reduction in the degree of intestinal metaplasia (46.2%, p<0.05 and lymphoplasmacytic infiltration (53.8%, p<0.05. Conclusions. This study justifies a randomised-controlled trial with CGNC in patients with atrophic gastritis.

  7. Safety Hazards During Intrahospital Transport: A Prospective Observational Study.

    Science.gov (United States)

    Bergman, Lina M; Pettersson, Monica E; Chaboyer, Wendy P; Carlström, Eric D; Ringdal, Mona L

    2017-10-01

    To identify, classify, and describe safety hazards during the process of intrahospital transport of critically ill patients. A prospective observational study. Data from participant observations of the intrahospital transport process were collected over a period of 3 months. The study was undertaken at two ICUs in one university hospital. Critically ill patients transported within the hospital by critical care nurses, unlicensed nurses, and physicians. None. Content analysis was performed using deductive and inductive approaches. We detected a total of 365 safety hazards (median, 7; interquartile range, 4-10) during 51 intrahospital transports of critically ill patients, 80% of whom were mechanically ventilated. The majority of detected safety hazards were assessed as increasing the risk of harm, compromising patient safety (n = 204). Using the System Engineering Initiative for Patient Safety, we identified safety hazards related to the work system, as follows: team (n = 61), tasks (n = 83), tools and technologies (n = 124), environment (n = 48), and organization (n = 49). Inductive analysis provided an in-depth description of those safety hazards, contributing factors, and process-related outcomes. Findings suggest that intrahospital transport is a hazardous process for critically ill patients. We have identified several factors that may contribute to transport-related adverse events, which will provide the opportunity for the redesign of systems to enhance patient safety.

  8. An Observational Study of Entrainment Rate in Deep Convection

    Directory of Open Access Journals (Sweden)

    Xiaohao Guo

    2015-09-01

    Full Text Available This study estimates entrainment rate and investigates its relationships with cloud properties in 156 deep convective clouds based on in-situ aircraft observations during the TOGA-COARE (Tropical Ocean Global Atmosphere Coupled Ocean Atmosphere Response Experiment field campaign over the western Pacific. To the authors’ knowledge, this is the first study on the probability density function of entrainment rate, the relationships between entrainment rate and cloud microphysics, and the effects of dry air sources on the calculated entrainment rate in deep convection from an observational perspective. Results show that the probability density function of entrainment rate can be well fitted by lognormal, gamma or Weibull distribution, with coefficients of determination being 0.82, 0.85 and 0.80, respectively. Entrainment tends to reduce temperature, water vapor content and moist static energy in cloud due to evaporative cooling and dilution. Inspection of the relationships between entrainment rate and microphysical properties reveals a negative correlation between volume-mean radius and entrainment rate, suggesting the potential dominance of homogeneous mechanism in the clouds examined. In addition, entrainment rate and environmental water vapor content show similar tendencies of variation with the distance of the assumed environmental air to the cloud edges. Their variation tendencies are non-monotonic due to the relatively short distance between adjacent clouds.

  9. Technological aspects of hospital communication challenges: an observational study.

    Science.gov (United States)

    Popovici, Ilinca; Morita, Plinio P; Doran, Diane; Lapinsky, Stephen; Morra, Dante; Shier, Ashleigh; Wu, Robert; Cafazzo, Joseph A

    2015-06-01

    To gain insights into how technological communication tools impact effective communication among clinicians, which is critical for patient safety. This multi-site observational study analyzes inter-clinician communication and interaction with information technology, with a focus on the critical process of patient transfer from the Emergency Department to General Internal Medicine. Mount Sinai Hospital, Sunnybrook Health Sciences Centre and Toronto General Hospital. At least five ED and general internal medicine nurses and physicians directly involved in patient transfers were observed on separate occasions at each institution. N/A. N/A. The study provides insight into clinician workflow, evaluates current hospital communication systems and identifies key issues affecting communication: interruptions, issues with numeric pagers, lack of integrated communication tools, lack of awareness of consultation status, inefficiencies related to the paper chart, unintuitive user interfaces, mixed use of electronic and paper systems and lack of up-to-date contact information. It also identifies design trade-offs to be negotiated: synchronous communication vs. reducing interruptions, notification of patient status vs. reducing interruptions and speed vs. quality of handovers. The issues listed should be considered in the design of new technology for hospital communications. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  10. Electromagnetictherapy for Treatment of Insomnia: A clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Fariba Sadeghi movahhed

    2012-04-01

    Full Text Available Background & Objectives: Insomnia is one of the most common sleep disorders in the world. It causes disruption in daily activities and increases the risk of major depression. Hence, clinically the appropriate and persistent treatment of insomnia is very important. Using of hypnotic drugs such as benzodiazepines is the common treatment for insomnia but they show several side effects and it seems that new medications should be used for treatment of sleep disorders. The aim of this study was comparison between the effects of electromagnetic therapy and conventional drug usage in the treatment of insomnia.   Methods: In a blind randomized clinical trial study, 60 people referred to the private office of the psychiatrist and experienced more than 3 months extended primary insomnia were selected. They were diagnosed by DSM-IV criteria and had no other underlying problems. The subjects were divided in two groups: 30 people in each and treated electromagnetically or with Alprazolam for 3 weeks. Before treatment, immediately and one month after treatment, quality of sleep and severity of the insomnia were evaluated by using the standard questionnaires and finally, the results were analyzed statistically.   Results : In this study, 60 individuals participated from whom 28 were male (46.7% and 32 patients were female (53.3%.The mean age was 37.3 years old in a range of 17- 65. The mean point of each questionnaire, before and immediately after treatment significantly didn't show any difference but one month after treatment, there was a significant difference in both groups.   Conclusion : To treat insomnia, electromagnetic therapy appears to be used as a replacement for sedative medicines. It also has more stability in comparison with other sedative medicines and no side effects have been reported yet.

  11. Impact of Cognitive Behavioral Therapy on Observed Autism Symptom Severity during School Recess: A Preliminary Randomized, Controlled Trial

    Science.gov (United States)

    Wood, Jeffrey J.; Fujii, Cori; Renno, Patricia; Van Dyke, Marilyn

    2014-01-01

    This study compared cognitive behavioral therapy (CBT) and treatment-as-usual (TAU) in terms of effects on observed social communication-related autism symptom severity during unstructured play time at school for children with autism spectrum disorders (ASD). Thirteen children with ASD (7-11 years old) were randomly assigned to 32 sessions of CBT…

  12. Assessing the completeness of reporting of observational studies in Colombian Journal of Anesthesiology. Cross sectional study

    NARCIS (Netherlands)

    Bravo-Peña, M. (Mary); Barona-Fong, L. (Luis); Campo-López, J. (Julio); Arroyave, Y. (Yeni); J.A. Calvache (Jose Andres)

    2017-01-01

    textabstractIntroduction The STROBE statement (Strengthening the Reporting of Observational Studies in Epidemiology), consisting of 22 points, was published in 2007 with the aim of improving the reporting of observational research. Objective To determine the completeness of reporting of

  13. Comparative Study after Hamstring Anterior Cruciate Ligament Reconstruction with Endobutton and Rigidfix: A Clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Hamid Mousavi

    2017-01-01

    Full Text Available Background: One of the most common orthopedic clinic visits involves direct and indirect knee trauma leading to rupture of anterior cruciate ligament (ACL. Endobutton and Rigidfix are most frequent treating methods that used by orthopedic surgeons. Thus the aim of this study was compare the clinical results of reconstructing arthroscopic ACL of the knee through two methods namely Rigidfix and Endobutton. Materials and Methods: In a clinical trial study, a total of 40 patients with rupture of ACL were selected and randomly divided into two groups. The groups were treated through fixation procedures either Endobutton or Rigidfix. Prior to surgery and then at least 2 years after surgery, the patients were under physical examination in terms of knee range of motion, knee stability, knee pain, ability to perform daily activities and exercises and compared between the two groups. Results: The knee range of motion in Endobutton and Rigidfix were 135.73 ± 2.63 and 129.87 ± 7.14° resprectively (P = 0.06. comparing two groups, during last month in Endobutton and Rigidfix the frequency of knee pain were 2.5 ± 1.4 and 3.4 ± 1.4 respectively (P = 0.08. Moreover, the pain intensity score were 2.9 ± 1.5 and 2.6 ± 1.1 (P = 0.49. But there was a significant difference observed in patients' satisfaction and ability to perform sports activities. Conclusions: The two fixation methods namely Endobutton and Rigidfix are not preferred over one another. But patients' satisfaction and ability to perform sports activities in Endobutton was better than the Rigidfix.

  14. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...... outcome measure was the 17-item Hamilton Rating Scale for Depression (HAM-D(17)), the secondary outcome measure was the percentage of days absent from work during the last 10 working days, and the tertiary outcome measure was effect on cognitive abilities. RESULTS: At 4 months, the strength measured by 1...

  15. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... outcome measure was the 17-item Hamilton Rating Scale for Depression (HAM-D(17)), the secondary outcome measure was the percentage of days absent from work during the last 10 working days, and the tertiary outcome measure was effect on cognitive abilities. RESULTS: At 4 months, the strength measured by 1...... versus the relaxation group. At 12 months, the mean differences in absence from work were -12.1% (-21.1% to -3.1%; p = .009) and -2.7% (-11.7% to 6.2%; p = .5) for the strength and aerobic groups versus the relaxation group. No statistically significant effect on cognitive abilities was found. CONCLUSION...

  16. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Saltin, Bengt; Gluud, Christian

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners...... or psychiatrists and were eligible if they fulfilled the International Classification of Diseases, Tenth Revision, criteria for unipolar depression and were aged between 18 and 55 years. Patients (N = 165) were allocated to supervised strength, aerobic, or relaxation training during a 4-month period. The primary...... repetition maximum for chest press increased by a mean (95% CI) of 4.0 kg (0.8 to 7.2; p = .014) in the strength training group versus the relaxation group, and maximal oxygen uptake increased by 2.7 mL/kg/min (1.2 to 4.3; p = .001) in the aerobic group versus the relaxation group. At 4 months, the mean...

  17. Ella-V and technology usage technology usage in an english language and literacy acquisition validation randomized controlled trial study

    OpenAIRE

    Roisin P. Corcoran; Steven M. Ross; Beverly J. Irby; Fuhui Tong; Rafael Lara-Alecio; Cindy Guerrero

    2014-01-01

    This paper describes the use of technology to provide virtual professional development (VPD) for teachers and to conduct classroom observations in a study of English Language Learner (ELL) instruction in grades K–3. The technology applications were part of a cluster randomized control trial (RCT) design for a federally funded longitudinal validation study of a particular program, English Language and Literacy Acquisition-Validation, ELLA- V, to determine its degree of impact on English oral l...

  18. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    DEFF Research Database (Denmark)

    Novick, D; Gonzalez-Pinto, A; Haro, J M

    2009-01-01

    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation......: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania....

  19. Clinical Trials

    Medline Plus

    Full Text Available ... list of NHLBI-sponsored clinical trials. NIH Clinical Research Studies Search for studies conducted within other Institutes at the NIH, including trials performed on our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  20. JAKE® Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder

    Directory of Open Access Journals (Sweden)

    Seth L. Ness

    2017-09-01

    Full Text Available Objective: To test usability and optimize the Janssen Autism Knowledge Engine (JAKE® system's components, biosensors, and procedures used for objective measurement of core and associated symptoms of autism spectrum disorder (ASD in clinical trials.Methods: A prospective, observational study of 29 children and adolescents with ASD using the JAKE system was conducted at three sites in the United States. This study was designed to establish the feasibility of the JAKE system and to learn practical aspects of its implementation. In addition to information collected by web and mobile components, wearable biosensor data were collected both continuously in natural settings and periodically during a battery of experimental tasks administered in laboratory settings. This study is registered at clinicaltrials.gov, NCT02299700.Results: Feedback collected throughout the study allowed future refinements to be planned for all components of the system. The Autism Behavior Inventory (ABI, a parent-reported measure of ASD core and associated symptoms, performed well. Among biosensors studied, the eye-tracker, sleep monitor, and electrocardiogram were shown to capture high quality data, whereas wireless electroencephalography was difficult to use due to its form factor. On an exit survey, the majority of parents rated their overall reaction to JAKE as positive/very positive. No significant device-related events were reported in the study.Conclusion: The results of this study, with the described changes, demonstrate that the JAKE system is a viable, useful, and safe platform for use in clinical trials of ASD, justifying larger validation and deployment studies of the optimized system.

  1. Development and initial validation of the Observer-Rated Housing Quality Scale (OHQS) in a multisite trial of housing first.

    Science.gov (United States)

    Adair, Carol E; Kopp, Brianna; Lavoie, Jennifer; Distasio, Jino; Hwang, Stephen W; Watson, Aimee; Veldhuizen, Scott; Chislett, Katherine; Voronka, Jijian; Ahmad, Muznah; Ahmed, Naveed; Goering, Paula

    2014-04-01

    Quality of housing has been shown to be related to health outcomes, including mental health and well-being, yet "objective" or observer-rated housing quality is rarely measured in housing intervention research. This may be due to a lack of standardized, reliable, and valid housing quality instruments. The objective of this research was to develop and validate the Observer-Rated Housing Quality Scale (OHQS) for use in a multisite trial of a "housing first" intervention for homeless individuals with mental illness. A list of 79 housing unit, building, and neighborhood characteristics was generated from a review of the relevant literature and three focus groups with consumers and housing service providers. The characteristics were then ranked by 47 researchers, consumers, and service providers on perceived importance, generalizability, universality of value, and evidence base. Items were then drafted, scaled (five points, half values allowed), and pretested in seven housing units and with seven raters using cognitive interviewing techniques. The draft scale was piloted in 55 housing units in Toronto and Winnipeg, Canada. Items were rated independently in each unit by two trained research assistants and a housing expert. Data were analyzed using classical psychometric approaches and intraclass correlation coefficients (ICC) for inter-rater reliability. The draft scale consisted of 34 items assessing three domains: the unit, the building, and the neighborhood. Five of 18 unit items and 3 of 7 building items displayed ceiling or floor effects and were adjusted accordingly. Internal consistency was very good (Cronbach's alpha = 0.90 for the unit items, 0.80 for the building items, and 0.92 total (unit and building)). Percent agreement ranged from 89 to 100 % within one response scale value and 67 to 91 % within one half scale value. Inter-rater reliability was also good (ICCs were 0.87 for the unit, 0.85 for the building, and 0.93 for the total scale). Three

  2. Diffusion of Bevacizumab Across Oncology Practices: An Observational Study.

    Science.gov (United States)

    Keating, Nancy L; Huskamp, Haiden A; Schrag, Deborah; McWilliams, John M; McNeil, Barbara J; Landon, Bruce E; Chernew, Michael E; Normand, Sharon-Lise T

    2018-01-01

    Technological advances can improve care and outcomes but are a primary driver of health care spending growth. Understanding diffusion and use of new oncology therapies is important, given substantial increases in prices and spending on such treatments. Examine diffusion of bevacizumab, a novel (in 2004) and high-priced biologic cancer therapy, among US oncology practices during 2005-2012 and assess variation in use across practices. Population-based observational study. A total of 2329 US practices providing cancer chemotherapy. Random 20% sample of 236,304 Medicare fee-for-service beneficiaries aged above 65 years in 2004-2012 undergoing infused chemotherapy for cancer. Diffusion of bevacizumab (cumulative time to first use and 10% use) in practices, variation in use across practices overall and by higher versus lower-value use. We used hierarchical models with practice random effects to estimate the between-practice variation in the probability of receiving bevacizumab and to identify factors associated with use. We observed relatively rapid diffusion of bevacizumab, particularly in independent practices and larger versus smaller practices. We observed substantial variation in use; the adjusted odds ratio (95% confidence interval) of bevacizumab use was 2.90 higher (2.73-3.08) for practices 1 SD above versus one standard deviation below the mean. Variation was less for higher-value [odds ratio=2.72 (2.56-2.89)] than lower-value uses [odds ratio=3.61 (3.21-4.06)]. Use of bevacizumab varied widely across oncology practices, particularly for lower-value indications. These findings suggest that interventions targeted to practices have potential for decreasing low-value use of high-cost cancer therapies.

  3. Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions

    Directory of Open Access Journals (Sweden)

    Eden Tim OB

    2010-10-01

    Full Text Available Abstract Background High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003 we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment. Methods We audio-recorded, transcribed and analysed routine doctor-patient consultations (n = 20 and interviews between researchers and parents (n = 30 parents across six UK treatment centres. Analysis was informed by the constant comparative method. For consultation transcripts, analysis focussed on how doctors presented the trial. We compared this with analysis of the interview transcripts which focussed on parents' perceptions and understanding of the trial. Results Parents and doctors discussed the trial in most consultations, even those that did not involve a decision about randomisation. Doctors used language allying them both with the trial and with the parent, indicating that they were both an 'investigator' and a 'clinician'. They presented the trial both as an empirical study with a scientific imperative and also as offering personalisation of treatment for the child. Parents appeared to understand that trial involvement was voluntary, that it was different from routine care and that they could withdraw from the trial at any time. Some were confused about the significance of the MRD test and the personalisation of treatment. Conclusions Doctors communicated in ways that generally promoted optimal recruitment, indicating that

  4. Study rationale and design of the CIMT trial: the Copenhagen Insulin and Metformin Therapy trial

    DEFF Research Database (Denmark)

    Lundby Christensen, L; Almdal, T; Boesgaard, T

    2009-01-01

    BACKGROUND: Patients with type 2 diabetes (T2DM) have an increased mortality rate primarily because of macrovascular disease. Where T2DM patients cannot be managed sufficiently through diet, exercise and peroral antidiabetic drugs, that is when haemoglobin A1c (HbA1c) is above 7.0%, it is yet...... in combination with one of three insulin analogue regimens, the primary outcome measure being carotid intima-media thickness (CIMT) in T2DM patients. DESIGN: A randomized, stratified, multicentre trial having a 2 x 3 factorial design. The metformin part is double masked and placebo controlled. The insulin...

  5. An observational study of foot lifts asymmetry during obstacle avoidance

    Directory of Open Access Journals (Sweden)

    Ujjawal Singh Tomar

    2012-01-01

    Full Text Available Background: Specific information regarding obstacle-clearance strategies used by community-dwelling young and elderly is scant in the literature, and physical barriers encountered in real-life situations have not been used in most of the studies. Aim: The aim of this study is to determine foot lift asymmetry during obstacle avoidance in young and elderly subjects. Settings and Design: This was an observational study. Materials and Methods: Thirty elderly and 30 young individuals were taken for the study. All the subjects were evaluated using different scales and foot lift asymmetry was measured on a walkway using three obstacles of different heights. Results: The mean and standard deviation (SD value of the asymmetric index of the young was 3.25±0.28 and the mean and SD value of the asymmetric index of the elderly was 3.53±0.47. The asymmetric index of the elderly population was found to be higher than that of the younger population. Conclusion: The asymmetric index of the elderly population was found to be higher than that of the younger population, though it is not clinically significant.

  6. Mucocutaneous manifestations of acquired hypoparathyroidism: An observational study

    Directory of Open Access Journals (Sweden)

    Somenath Sarkar

    2012-01-01

    Full Text Available Hypoparathyroidism is a disorder of calcium and phosphorus metabolism due to decreased secretion of parathyroid hormone. Hypoparathyroidism can be hereditary and acquired. Acquired hypoparathyroidism usually occurs following neck surgery (thyroid surgery or parathyroid surgery. Along with systemic manifestations, hypoparathyroidism produces some skin manifestations. Lack of study regarding mucocutaneous manifestations of acquired hypoparathyroidism prompted us to undertake this study. To evaluate the mucocutaneous manifestations of acquired hypoparathyroidism. An observational study done in a tertiary care hospital of Kolkata by comprehensive history taking, through clinical examination and relevant laboratory investigations. Twenty-one patients were included in the study. The commonest form of acquired hypoparathyroidism was neck surgery (thyroidectomy and parathyroidectomy operation. Mucocutaneous manifestations were present in 76.19% of patients. The most frequent mucocutaneous manifestation was found in the hairs like the loss of axillary hair (61.9%, loss of pubic hair (52.38%, coarsening of body hair (47.62%, and alopecia areata (9.52%. The nail changes noted were brittle and ridged nail, followed by onycholysis, onychosezia, and onychomedesis. The most common skin features were xerotic skin in 11 patients (52.38%, followed by pellagra-like skin pigmentation, pustular psoriasis and acne form eruption, bullous impetigo, etc. Mucosa was normal in all the cases excepting the one which showed oral candidiasis.

  7. Critical Observation on Methodologies of Select Doctoral Research Studies

    Directory of Open Access Journals (Sweden)

    Dr Indrajit Goswami

    2014-12-01

    Full Text Available The present article aims to critically observe and interpret the methodological deficiencies as found in randomly selected 14 doctoral theses submitted to two different universities in India. Despite their serious deviation from the expected methodological standards, all those theses were accepted and approved by the universities and scholars concerned conferred with PhD degrees. Undoubtedly, those theses kept in the reference sections at the respective university libraries would potentially misguide and mislead the future researchers. Some of the common technical deficiencies, as have been noticed, include (1 absence of careful thoughts in framing research titles, (ii biased method of data collection, (ii absence of logical explanation in favour of sample size and sample selection process, (iii designing and execution of instrument for data collection, (iv theory formulation in terms of framing of objectives, hypotheses and operational definitions etc. The article attempts to present the critical observations on case-to-case basis so that their conceptual, instrumental and procedural deficiencies and deviations are easily understood by the academicians, researchers and students. The content of this article is divided in to three broad sections. The first section deals with an introduction to quantitative and qualitative research methods and their advantages and limitations. The next section deals with the review of the selected theses followed by conclusion and suggested remedial measures. The objective of this article is purely academic and its scope is limited to enhancement of quality of future research studies in the domains and related fields.

  8. A study of GPS ionospheric scintillations observed at Guilin

    Science.gov (United States)

    Zou, Yuhua; Wang, Dongli

    2009-12-01

    The occurrence of strong ionospheric scintillations with S4>=0.2 was studied using global positioning system (GPS) measurements at Guilin (25.29°N, 110.33°E; geomagnetic: 15.04°N, 181.98°E), a station located near the northern crest of equatorial anomaly in China. The results are presented for data collected from January 2007 to December 2008. The results show that amplitude scintillations occurred only during the first five months of the considered years. Nighttime amplitude scintillations, observed mainly in the south of Guilin, always occurred with phase scintillations, total electron content (TEC) depletions, and Rate Of change of TEC (ROT) fluctuations. However, TEC depletions and ROT fluctuations were weak during daytime amplitude scintillations, and daytime amplitude scintillations usually occurred in most of the azimuth directions. GPS scintillation/TEC observations recorded at Guilin and signal-to-noise-ratio measurements obtained from GPS-COSMIC radio occultation indicate that nighttime and daytime scintillations are very likely caused by ionospheric F region irregularities and sporadic E, respectively.

  9. ACE inhibitors and the risk of fractures: a meta-analysis of observational studies.

    Science.gov (United States)

    Cheng, Yan-Zhen; Huang, Zhen-Zi; Shen, Ze-Feng; Wu, Hai-Yang; Peng, Jia-Xin; Waye, Mary Miu Yee; Rao, Shi-Tao; Yang, Li

    2017-03-01

    A meta-analysis was conducted to evaluate the effect of treatment with angiotensin-converting enzyme inhibitors on the risk of fractures. All the included articleswere retrieved from MEDLINE, EMBASE and the Cochrane Database. Trial eligibility and methodological quality were assessed before data extraction. Relative risk (RR) with corresponding 95% confidence intervals (95% CI) were used to assess the effect. Six case-control studies with11,387,668 participants met the inclusion criteria and were included in the meta-analysis. A small but significant risk effect on fractures was shown in the overall analysis of angiotensin-converting enzyme inhibitor users compared with nonusers (Pooled RR 1.27; 95% CI 1.01-1.60), although a relatively high heterogeneity was found across studies. In the stratified analysis, therewas no statistically significant association in the subgroups of hip fracture (Pooled RR 1.14; 95% CI 0.73-1.76) and the study quality (Pooled RR 1.13; 95% CI 0.89-1.44), while the over 65-year-old angiotensin-converting enzyme inhibitor users showed a stronger risk effect on fractures (Pooled RR 2.06; 95% CI 1.53-3.17). Moreover, age was found to be contributed a large part of the high heterogeneity across the included studies. This study demonstrated that the use of angiotensin-converting enzyme inhibitors might have a small but significant risk effect on fractures, especially for the over 65-year-old users. These results should be interpreted with caution as the relatively high heterogeneity across studies. Additional multiple observational studies and high quality data from randomized controlled trials are needed to confirm these findings.

  10. An observational study towards a newer classification in child psychiatry

    Directory of Open Access Journals (Sweden)

    Shyamanta Das

    2017-01-01

    Full Text Available Background: The first manifestations of majority of mental disorders are seen in childhood and adolescence. They result in burden in this age group as well. Materials and methods: A different way of classifying psychiatric disorders in children and adolescents categorise them into emotional, disruptive, and developmental disorders. We carried out an observational study to validate such an approach towards diagnosis. Results: Sample was almost equally divided in the two age groups as well as between the sexes. The distribution of emotional, disruptive, and developmental disorders in the younger and older age groups were 4:3:2 and 5:0:1 respectively. The same for boys and girls were 4:2:1 and 4:1:2 respectively. Comorbidity was same within group and across groups. Conclusion: A simplified diagnostic approach in child psychiatry has the potential of bridging the gap among the different ‘gatekeepers’ toward psychiatric service utilisation.

  11. Nursing diagnoses in patients with chronic venous ulcer: observational study

    Directory of Open Access Journals (Sweden)

    Glycia de Almeida Nogueira

    2015-06-01

    Full Text Available This study aimed to analyze nursing diagnoses in people with chronic venous ulcer. An observational, descriptive, quantitative research conducted in an ambulatory specialized in wound treatment, with a non-probabilistic sample of 20 patients.  Data collection was performed in an institutional form denominated Assessment Protocol for Clients with Tissue Lesions. Diagnoses were established by consensus among four researchers with experience in nursing diagnoses and wound treatments. From data analysis, 16 diagnoses were identified, with 100% of participants presenting: Impaired tissue integrity, Ineffective peripheral tissue perfusion, Risk of infection, Impaired physical mobility and Ineffective health self-control. These diagnoses are found in Safety/Protection, Activity/Rest and Health promotion domains, which from the clinical practice stand point should be priority focuses in nursing intervention and assessment.

  12. [Assessment of Urinary Incontinence in Pregnancy and Postpartum: Observational Study].

    Science.gov (United States)

    Rocha, Juliana; Brandão, Pedro; Melo, Anabela; Torres, Silvia; Mota, Lurdes; Costa, Fernanda

    2017-08-31

    The urinary incontinence can affect up to 50% of women at some stage of their lives, particularly during pregnancy and postpartum. This study was designed in order to identify and assess the prevalence and risk factors for urinary incontinence during the third trimester of pregnancy and three months postpartum. Observational and cross-sectional study. The population of the study was composed of 268 women who delivered and were admitted to the Centro Hospitalar Tâmega e Sousa in the years 2013 and 2014, and who agreed to participate in this study. Postpartum women were asked to fill out a questionnaire adapted from the International Consultation on Incontinence Questionnaire - Short Form, for urinary incontinence research in the third trimester of pregnancy. Three months after delivery, they were contacted by telephone and asked to answer the same questions about the urinary incontinence postpartum. Of the 268 women interviewed, 31 were excluded from the study, taking into account the defined inclusion and exclusion criteria. In total (n = 237), 51.89% of women included in the study, reported the occurrence of urinary incontinence during pregnancy. The prevalence of urinary incontinence in pregnancy by parity (primiparous versus multiparous) was statistically significant (p = 0.006). At postpartum (n = 237), 28.69% of women with urinary incontinence had vaginal delivery and 5.91% of women underwent cesarean delivery (p = 0.001). In these group of women with postpartum urinary incontinence (n = 82), 31.69% have had urinary incontinence only in the postpartum and 68.31% of women have had symptoms during pregnancy (p urinary incontinence in pregnancy and the respective decrease in postpartum. Multiparity and occurrence of urinary incontinence in pregnancy appear as potential risk factors in the emergence of the urinary incontinence.

  13. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    : The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...... trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1) specialized addiction treatment plus treatment as usual or 2......) treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient.The primary outcome measure will be changes in amount...

  14. Obesity in adolescents with chronic fatigue syndrome: an observational study.

    Science.gov (United States)

    Norris, T; Hawton, K; Hamilton-Shield, J; Crawley, E

    2017-01-01

    Identify the prevalence of obesity in patients with chronic fatigue syndrome (CFS) compared with healthy adolescents, and those identified with CFS in a population cohort. Cross-sectional analysis of multiple imputed data. Data from UK paediatric CFS/myalgic encephalomyelitis (CFS/ME) services compared with data collected at two time points in the Avon Longitudinal Study of Parents and Children (ALSPAC). 1685 adolescents who attended a CFS/ME specialist service between 2004 and 2014 and 13 978 adolescents aged approximately 13 years and 16 years participating in the ALSPAC study. Body mass index (BMI) (kg/m 2 ), sex-specific and age-specific BMI Z-scores (relative to the International Obesity Task Force cut-offs) and prevalence of obesity (%). Adolescents who had attended specialist CFS/ME services had a higher prevalence of obesity (age 13 years: 9.28%; age 16 years: 16.43%) compared with both adolescents classified as CFS/ME in ALSPAC (age 13 years: 3.72%; age 16 years: 5.46%) and those non-CFS in ALSPAC (age 13 years: 4.18%; age 16 years: 4.46%). The increased odds of obesity in those who attended specialist services (relative to non-CFS in ALSPAC) was apparent at both 13 years (OR: 2.31 (1.54 to 3.48)) and 16 years, with a greater likelihood observed at 16 years (OR: 4.07 (2.04 to 8.11)). We observed an increased prevalence of obesity in adolescents who were affected severely enough to be referred to a specialist CFS/ME service. Further longitudinal research is required in order to identify the temporal relationship between the two conditions. 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/.

  15. Splenic lesions observed in 71 splenectomized dogs: a retrospective study

    Directory of Open Access Journals (Sweden)

    Elisângela Olegário da Silva

    2016-10-01

    Full Text Available The spleen of dogs is frequently affected by disorders that vary from local and systemic origin. The difficulty in associating clinical and gross findings contributes for the choice of total splenectomy as the main treatment, leading to an impairment of the immune and hematopoietic functions. The aim of this study was to evaluate the pathological findings in the spleen of splenectomized dogs during 2008 to 2014 at a Veterinary Teaching Hospital. From the 71 cases analyzed, 97% (69/71 of the dogs were submitted to total splenectomy and 3% (2/71 to partial splenectomy. In 45 (63.4% of these cases, the histopathological diagnosis was non-neoplastic alterations; only 36.6% (26/71 had a splenic neoplasia. The main non-neoplastic lesions observed were nodular hyperplasia 24.4% (11/45, infarction 22.3% (10/45, and hematoma 20% (9/45. The most frequent tumors were hemangiosarcoma 50% (13/26, histiocytic sarcoma 23% (6/26, and lymphoma 11.5% (3/26. The clinical methods used to diagnose splenic lesions were ultrasonography 88% (63/71, radiography 2.8% (2/71 and exploratory laparotomy 4.2% (3/71. In 4.2% (3/71 the spleen changes were observed during the therapeutic ovariohysterectomy. The results of the present study showed a prevalence of benign disorders in the spleen of splenectomized dogs associated with a high incidence of total splenectomy performed, indicating a difficulty in recognizing the different lesions that can affect the spleen by the veterinarian medical.

  16. Observational Study of Solar Magnetic Active Phenomena Hongqi ...

    Indian Academy of Sciences (India)

    1991-06-09

    Jun 9, 1991 ... active region NOAA 6580-6619-6659 observed at Huairou Solar Observing Station of. National Astronomical Observatories of China in 1991 (Ai & Hu ... The white arrows mark the observed transverse field and the black arrows show the transverse components inferred from the calculation of magnetic ...

  17. Observational study of sleep disturbances in advanced cancer.

    Science.gov (United States)

    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.

  18. Tea consumption may decrease the risk of osteoporosis: an updated meta-analysis of observational studies.

    Science.gov (United States)

    Guo, Ming; Qu, Hua; Xu, Lin; Shi, Da-Zhuo

    2017-06-01

    Several epidemiological investigations have evaluated the correlation between tea consumption and risk of osteoporosis, but the results are inconsistent. Therefore, we conducted an updated meta-analysis of observational studies to assess this association. We searched for all relevant studies including cohort, cross-sectional, and case-control studies published from database inception to July 15, 2016, using MEDLINE EMBASE, and Cochrane Library. Polled odds ratios (ORs) were calculated using the random-effect model. Fourteen articles (16 studies) that examined 138523 patients were included in this meta-analysis. Seven studies concerning bone mineral density (BMD) showed an increase in BMD with tea consumption, including 4 cross-sectional studies (OR, 0.04, 95% confidence interval [CI], 0.01-0.08) and 3 cohort studies (OR, 0.01; 95% CI, 0.01-0.01). The remaining 9 studies concerning fracture, including 6 case-control studies and 3 cohort studies, showed no association between tea consumption and osteoporotic fracture (OR, 0.86; 95% CI, 0.74-1.01). This updated meta-analysis demonstrates that tea consumption could increase BMD, but the association with osteoporotic fracture requires further investigation. Together, the results highlight the need for future, high-quality-designed clinical trials on tea consumption and osteoporosis. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poh Catherine F

    2011-10-01

    Full Text Available Abstract Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160 and invasive squamous cell carcinoma (N = 240. Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm or white light-guided surgery (control arm. The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1 the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization; or 2 further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS

  20. Observational studies of X-ray binary systems

    International Nuclear Information System (INIS)

    Klis, M. van der.

    1983-01-01

    The subject of Chapter 1 is theoretical. The other chapters, Ch. 2 to 6, contain original observational data and efforts towards their interpretation. Of these, Ch. 3, 4 and 5 deal with massive X-ray binaries, Ch. 6 with low-mass systems and Ch. 2 with Cygnus X-3, which we have not yet been able to assign to any of these two classes. The X-ray observations described were made with the COS-B satellite. Work based on UV and optical observations is described in Ch. 5. The UV observations were made with the IUE satellite, the optical observations at several ground-based observatories. (Auth.)

  1. Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study.

    Science.gov (United States)

    Vischer, Nerina; Pfeiffer, Constanze; Kealy, Jennifer; Burri, Christian

    2017-01-01

    The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa. We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main themes distilled from the interviews. Protocol suitability surfaced as a prominent topic in interviews with trial staff, critiqued for its lack of clarity, implementability and adaptation to trial participants as well as to the workforce and infrastructure available. Both qualitative and quantitative investigations identified local site staff involvement in protocol development as the most helpful mean of increasing protocol suitability. Careful assessment of the local context, capacity and cultures, and ensuring that staff understand the protocol were also cited as helpful measures. Our data suggests that protocol suitability can be increased by discussing and reviewing the protocol with trial staff in advance. Involving operationally experienced staff would be most useful. For multicentre trials, we suggest that at least one trial staff member from each of the sites with the highest expected recruitment rates be involved in developing the protocol. Carefully assessing the context prior to study start is indispensable to ensuring protocol suitability and should particularly focus on the workforce and infrastructure available, as well as the needs and availability of trial participants. To allow for protocol

  2. A STUDY TO DETERMINE CO‐RELATION BETWEEN DISEASE BURDEN, NUMBER OF CLINICAL TRIALS DONE AND SUCCESS RATES FOR GERMANY AND INDIA.

    Directory of Open Access Journals (Sweden)

    Dnyanesh Limaye

    2014-12-01

    Full Text Available The drugs we use to treat any condition – from an innocuous cough to a lifethreatening cancer – are the outcome of painstaking human clinical trials. These trials are the only way to credibly determine the safety and efficacy of drugs. In recent years there has been a clear shift in clinical trial sites from core developed countries like USA, European countries to developing countries like India, China, South American countries. This shift is related to challenges and opportunities like costs of trials, recruitment issues, and regulatory challenges in developed vs. developing countries. Developing countries and developed countries have their unique disease burden patterns based on various parameters like but not limited to age, health care facilities, health insurance, sanitary conditions, environmental issues, education, nutrition and GDP. Previous studies have reported that many of the important global diseases are not much explored in clinical trials and many published clinical trials have very less international health relevance. This study was aimed at finding the correlation between disease burdens, number of clinical trials done and trial success rates. We compared 2005-2010 Global Burden of Disease data for Germany, India and number of clinical trials from clinicaltrials.gov database done in the same period. Our findings indicated that there was a good correlation between the disease burden and clinical trials for Germany in 2005 and 2010. For India in 2005 there was a moderate positive correlation, 2010 data showed the improvement in India in terms of match between disease burden and clinical Trials. But careful observation of the data shows still a need for more trials on Communicable, maternal, neonatal and nutritional disorders.

  3. Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a prior history - an open-label randomised trial (the EPPI trial): study protocol.

    Science.gov (United States)

    Groom, K M; McCowan, L M; Stone, P R; Chamley, L C; McLintock, C

    2016-11-22

    Preeclampsia and intrauterine fetal growth restriction (IUGR) are two of the most common causes of maternal and perinatal morbidity and mortality. Current methods of predicting those at most risk of these conditions remain relatively poor, and in clinical practice past obstetric history remains the most commonly used tool. Aspirin and, in women at risk of preeclampsia only, calcium have been demonstrated to have a modest effect on risk reduction. Several observational studies and randomised trials suggest that low molecular weight heparin (LMWH) therapy may confer some benefit. This is a multicentre open label randomised controlled trial to determine the effect of the LMWH, enoxaparin, on the prevention of recurrence of preeclampsia and/or IUGR in women at high risk due to their past obstetric history in addition to standard high risk care for all participants. A singleton pregnancy >6 +0 and 12 weeks having; (1) preeclampsia delivered preeclampsia). The primary outcome is preeclampsia and/or SGA prevention of placental mediated conditions. ACTRN12609000699268 Australian New Zealand Clinical Trials Registry. Date registered 13/Aug/2009 (prospective registration).

  4. Reporting outcomes of back pain trials: A modified Delphi study

    DEFF Research Database (Denmark)

    Froud, Robert; Eldridge, Sandra; Kovacs, Francisco

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi...

  5. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.

    Science.gov (United States)

    Capeding, Maria Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki S; Ismail, Hussain Imam H J Muhammad; Chotpitayasunondh, Tawee; Chua, Mary Noreen; Luong, Chan Quang; Rusmil, Kusnandi; Wirawan, Dewa Nyoman; Nallusamy, Revathy; Pitisuttithum, Punnee; Thisyakorn, Usa; Yoon, In-Kyu; van der Vliet, Diane; Langevin, Edith; Laot, Thelma; Hutagalung, Yanee; Frago, Carina; Boaz, Mark; Wartel, T Anh; Tornieporth, Nadia G; Saville, Melanie; Bouckenooghe, Alain

    2014-10-11

    An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children. We did an observer-masked, randomised controlled, multicentre, phase 3 trial in five countries in the Asia-Pacific region. Between June 3, and Dec 1, 2011, healthy children aged 2-14 years were randomly assigned (2:1), by computer-generated permuted blocks of six with an interactive voice or web response system, to receive three injections of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV), or placebo, at months 0, 6, and 12. Randomisation was stratified by age and site. Participants were followed up until month 25. Trial staff responsible for the preparation and administration of injections were unmasked to group allocation, but were not included in the follow-up of the participants; allocation was concealed from the study sponsor, investigators, and parents and guardians. Our primary objective was to assess protective efficacy against symptomatic, virologically confirmed dengue, irrespective of disease severity or serotype, that took place more than 28 days after the third injection. The primary endpoint was for the lower bound of the 95% CI of vaccine efficacy to be greater than 25%. Analysis was by intention to treat and per procotol. This trial is registered with ClinicalTrials.gov, number NCT01373281. We randomly assigned 10,275 children to receive either vaccine (n=6851) or placebo (n=3424), of whom 6710 (98%) and 3350 (98%), respectively, were included in the primary analysis. 250 cases of virologically confirmed dengue took place more than 28 days after the third injection (117 [47%] in the vaccine group and 133 [53%] in the control group). The primary endpoint was achieved with 56·5% (95% CI 43·8-66·4) efficacy. We recorded 647 serious adverse

  6. Comparative Effectiveness of Initial Antiretroviral Therapy Regimens: ACTG 5095 and 5142 Clinical Trials Relative to ART-CC Cohort Study

    Science.gov (United States)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.

    2011-01-01

    Background The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Methods Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Results Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Conclusions Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts. PMID:21857357

  7. Satellite Observation Systems for Polar Climate Change Studies

    Science.gov (United States)

    Comiso, Josefino C.

    2012-01-01

    The key observational tools for detecting large scale changes of various parameters in the polar regions have been satellite sensors. The sensors include passive and active satellite systems in the visible, infrared and microwave frequencies. The monitoring started with Tiros and Nimbus research satellites series in the 1970s but during the period, not much data was stored digitally because of limitations and cost of the needed storage systems. Continuous global data came about starting with the launch of ocean color, passive microwave, and thermal infrared sensors on board Nimbus-7 and Synthetic Aperture Radar, Radar Altimeter and Scatterometer on board SeaSat satellite both launched in 1978. The Nimbus-7 lasted longer than expected and provided about 9 years of useful data while SeaSat quit working after 3 months but provided very useful data that became the baseline for follow-up systems with similar capabilities. Over the years, many new sensors were launched, some from Japan Aeronautics and Space Agency (JAXA), some from the European Space Agency (ESA) and more recently, from RuSSia, China, Korea, Canada and India. For polar studies, among the most useful sensors has been the passive microwave sensor which provides day/night and almost all weather observation of the surface. The sensor provide sea surface temperature, precipitation, wind, water vapor and sea ice concentration data that have been very useful in monitoring the climate of the region. More than 30 years of such data are now available, starting with the Scanning Multichannel Microwave Radiometer (SMMR) on board the Nimbus-7, the Special Scanning Microwave/Imager (SSM/I) on board a Defense Meteorological Satellite Program (DMSP) and the Advanced Microwave Scanning Radiometer on board the EOS/ Aqua satellite. The techniques that have been developed to derive geophysical parameters from data provided by these and other sensors and associated instrumental and algorithm errors and validation techniques

  8. Ions, isotopes, and metal cyanides: Observational and laboratory studies

    Science.gov (United States)

    Savage, Chandra Shannon

    2004-11-01

    Chemistry in the interstellar medium is very different from the processes which take place in terrestrial settings. Environments such as circumstellar envelopes, molecular clouds, and comets contain diverse and complex chemical networks. The low temperatures (10 50 K) and densities (1 10 6 cm-3) allow normally unstable molecules to exist in significant quantities. At these temperatures, the rotational energy levels of molecules are populated, and thus these species can be detected by millimeter-wave radio astronomy. The detection and quantification of interstellar molecules, including metal cyanides and molecular ions, is the basis of this dissertation work. While conducting observations of CN and 13CN to determine the 12C/13C ratio throughout the Galaxy, it was found that the ratios in photon- dominated regions (PDRs) were much higher than those in nearby molecular clouds. This can be explained by isotope-selective photodissociation, in which the 12CN molecules are self-shielded. However, the chemistry in these regions is poorly understood, and other processes may be occurring. In order to understand one of the chemical networks present in PDRs, observations of HCO+, HOC +, and CO+ were made toward several of these sources. Previous studies indicated that the HCO+/HOC+ ratio was much lower in PDRs, due to the presence of CO+. The new observations indicate that there is a strong correlation between CO + and HOC+ abundances, which suggests that other molecular ions which have not been detected in molecular clouds may be present in PDRs. There is a significant obstacle to the detection of new interstellar molecular ions, however. The laboratory spectra are virtually unknown for many of these species, due to their inherent instability. Thus, techniques which can selectively detect ionic spectra must be utilized. One such method is velocity modulation, which incorporates an AC electrical discharge to produce and detect ions. Previously, velocity modulation spectroscopy

  9. Oral implications of the vegan diet: observational study.

    Science.gov (United States)

    Laffranchi, L; Zotti, F; Bonetti, S; Dalessandri, D; Fontana, P

    2010-01-01

    The aim of this study was to investigate oral changes in subjects who have assumed a vegan diet for a long time (at least 18 months), that is to say, a diet completely lacking in meat and animal derivatives. A sample of 15 subjects was analyzed, all from northern Italy and aged 24 to 60 year, composed of 11 men and 4 women who had been following a vegan diet for a minimum of 18 months to a maximum of 20 years. In parallel with the study sample, a control group (15 subjects) with the same criteria of age, sex, and place of origin all following an omnivorous diet was chosen. The sample answered a questionnaire that investigated their eating habits, the frequency with which they eat meals, the main foodstuffs assumed, oral hygiene habits, and any painful symptomatology of the teeth or more general problems in the oral cavity. The sample was then subject to objective examination in which the saliva pH was measured and the teeth were checked for demineralization of the enamel, white spots, and caries (using KaVo DIAGNOdent) with particular attention being paid to the localization of these lesions, and lastly, sounding was carried out to detect any osseous defects and periodontal pockets. The study revealed greater incidence of demineralization and white spots in the vegan subjects compared to the omnivorous ones localized at the neck of the teeth and on the vestibular surfaces of dental elements (with the exception of the lower anterior group). The saliva pH, more acid in the omnivorous patients, ranged between four and six. Changes in oral conditions in both groups of subjects were observed. In order to research into the cause-effect relationship of the vegan diet on the oral cavity effectively, the sample needs to be studied for a longer period of time and the results re-evaluated.

  10. Evaluation of Xerostomia in Different Psychological Disorders: An Observational Study.

    Science.gov (United States)

    Veerabhadrappa, Suresh Kandagal; Chandrappa, Pramod Redder; Patil, Snehal; Roodmal, Seema Yadav; Kumarswamy, Akshay; Chappi, Mounesh Kumar

    2016-09-01

    Psychiatric diseases like anxiety, depression, schizophrenia and bipolar disorders are increasing at an alarming rate. These diseases can affect the quantity and quality of saliva leading to multiple oral diseases. Although many researchers have evaluated xerostomia in general population, its prevalence is not been assessed in patients suffering from different psychological disorders. To investigate the prevalence of xerostomia and to assess the correlation between xerostomia and dryness of lip and mucosa in different psychological disorders. A cross-sectional observational study was conducted over a period of six months in Department of Psychiatry and Department of Oral Medicine. Patients with anxiety, depression, schizophrenia and bipolar disorder, as diagnosed by an experienced psychiatrist, were given a questionnaire to evaluate the xerostomia. Patients with symptoms of xerostomia were subjected to oral examination by a skilled oral diagnostician to check for dryness of lips and mucosa. One hundred patients from each group of psychiatric diseases were included in the study using a consecutive sampling technique. An equal number of healthy individuals reporting to oral medicine department for routine oral screening were included as control group after initial psychiatric evaluation. In this study statistically significant increase in the xerostomia in psychiatric patients was recorded when compared to the control group (pXerostomia was significantly higher in anxiety patients (51%) followed by depression (47%), bipolar disorder (41%), schizophrenia (39%) and control group (27%). The majority of the psychiatric patients had 'moderate' to 'severe' xerostomia whereas the control group had 'mild' xerostomia. Xerostomia was significantly higher in younger age group (18-49 years) than in older age group and females patients had higher xerostomia than male patients. Psychiatric patients had significantly more dryness of lip and mucosa than healthy controls. A moderate

  11. Estimation of Skin to Subarachnoid Space Depth: An Observational Study.

    Science.gov (United States)

    Hazarika, Rajib; Choudhury, Dipika; Nath, Sangeeta; Parua, Samit

    2016-10-01

    In a patient, the skin to Subarachnoid Space Depth (SSD) varies considerably at different levels of the spinal cord. It also varies from patient to patient at the same vertebral level as per age, sex and Body Mass Index (BMI). Estimation of the skin to SSD reduces complications related to spinal anaesthesia. To measure the skin to SSD in the Indian population and to find a formula for predicting this depth. Three hundred adult patients belonging to American Society of Anaesthesiologist class I and II, undergoing surgery using spinal anaesthesia in various surgical specialities of Gauhati Medical College were selected by systemic sampling for this prospective, observational study. Patients were divided into three groups: Group M containing male patients, Group F containing non-pregnant female patients, and Group PF containing pregnant female's patients. SSD was measured after performing lumbar puncture. The relationship between SSD and patient characteristics were studied, correlated and statistical analysis was used to find a formula for predicting the skin to SSD. Statistical analysis was done using Statistical Package for Social Sciences (SPSS 21.0, Chicago, IL, USA). One-way ANOVA with post-hoc(Bonferroni correction factor) analysis was applied to compare the three groups. Multivariate analysis was done for the covariates followed by a multivariate regression analysis to evaluate the covariates influencing SSD for each group separately. Mean SSD was 4.37±0.31cm in the overall population. SSD in adult males was 4.49±0.19cm which was significantly longer than that observed in female's 4.18±0.39cm which was comparable with SSD in parturient 4.43±0.19 cm. The formula for predicting the skin to SSD in the male population was 1.718+0.077×BMI+0.632×Height, in nonpregnant female population was 1.828+0.077×BMI+0.018×Height+0.007×Age and 0.748+0.209×BMI+4.703×Height-0.054×weight in parturient females, respectively. Skin to SSD correlated with the BMI in all

  12. Southeast Atmosphere Studies: learning from model-observation syntheses

    Science.gov (United States)

    Mao, Jingqiu; Carlton, Annmarie; Cohen, Ronald C.; Brune, William H.; Brown, Steven S.; Wolfe, Glenn M.; Jimenez, Jose L.; Pye, Havala O. T.; Ng, Nga Lee; Xu, Lu; McNeill, V. Faye; Tsigaridis, Kostas; McDonald, Brian C.; Warneke, Carsten; Guenther, Alex; Alvarado, Matthew J.; de Gouw, Joost; Mickley, Loretta J.; Leibensperger, Eric M.; Mathur, Rohit; Nolte, Christopher G.; Portmann, Robert W.; Unger, Nadine; Tosca, Mika; Horowitz, Larry W.

    2018-02-01

    Concentrations of atmospheric trace species in the United States have changed dramatically over the past several decades in response to pollution control strategies, shifts in domestic energy policy and economics, and economic development (and resulting emission changes) elsewhere in the world. Reliable projections of the future atmosphere require models to not only accurately describe current atmospheric concentrations, but to do so by representing chemical, physical and biological processes with conceptual and quantitative fidelity. Only through incorporation of the processes controlling emissions and chemical mechanisms that represent the key transformations among reactive molecules can models reliably project the impacts of future policy, energy and climate scenarios. Efforts to properly identify and implement the fundamental and controlling mechanisms in atmospheric models benefit from intensive observation periods, during which collocated measurements of diverse, speciated chemicals in both the gas and condensed phases are obtained. The Southeast Atmosphere Studies (SAS, including SENEX, SOAS, NOMADSS and SEAC4RS) conducted during the summer of 2013 provided an unprecedented opportunity for the atmospheric modeling community to come together to evaluate, diagnose and improve the representation of fundamental climate and air quality processes in models of varying temporal and spatial scales.This paper is aimed at discussing progress in evaluating, diagnosing and improving air quality and climate modeling using comparisons to SAS observations as a guide to thinking about improvements to mechanisms and parameterizations in models. The effort focused primarily on model representation of fundamental atmospheric processes that are essential to the formation of ozone, secondary organic aerosol (SOA) and other trace species in the troposphere, with the ultimate goal of understanding the radiative impacts of these species in the southeast and elsewhere. Here we

  13. Study of Rayleigh-Love coupling from Spatial Gradient Observation

    Science.gov (United States)

    Lin, C. J.; Hosseini, K.; Donner, S.; Vernon, F.; Wassermann, J. M.; Igel, H.

    2017-12-01

    We present a new method to study Rayleigh-Love coupling. Instead of using seismograms solely, where ground motion is recorded as function of time, we incorporate with rotation and strain, also called spatial gradient where ground is represented as function of distance. Seismic rotation and strain are intrinsic different observable wavefield so are helpful to indentify wave type and wave propagation. A Mw 7.5 earthquake on 29 March 2015 occurred in Kokopo, Papua New Guinea recorded by a dense seismic array at PFO, California are used to obtaint seismic spatial gradient. We firstly estimate time series of azimuthal direction and phase velocity of SH wave and Rayleigh wave by analyzing collocated seismograms and rotations. This result also compares with frequency wavenumber methods using a nearby ANZA seismic array. We find the direction of Rayleigh wave fits well with great-circle back azimuth during wave propagation, while the direction of Love wave deviates from that, especially when main energy of Rayleigh wave arrives. From the analysis of cross-correlation between areal strain and vertical rotation, it reveals that high coherence, either positive or negative, happens at the same time when Love wave deparate from great-circle path. We also find the observed azimuth of Love wave and polarized particle motion of Rayleigh wave fits well with the fast direction of Rayleigh wave, for the period of 50 secs. We conclude the cause of deviated azimuth of Love wave is due to Rayleigh-Love coupling, as surface wave propagates through the area with anisotropic structure.

  14. [Pregnancy-Associated Breast Cancer: An analytical observational study].

    Science.gov (United States)

    Baulies, Sonia; Cusidó, Maite; Tresserra, Francisco; Rodríguez, Ignacio; Ubeda, Belén; Ara, Carmen; Fábregas, Rafael

    2014-03-04

    Pregnancy-associated breast cancer is defined as breast cancer diagnosed during pregnancy and up to one year postpartum. A retrospective, analytical, observational study comparing 56 cases of breast cancer and pregnancy (PABC) diagnosed 1976-2008 with 73 patients with breast cancer not associated with pregnancy (non-PABC) was performed. Demographic data, prognostic factors, treatment and survival were reviewed and compared. The prevalence of PABC in our center is 8.3/10,000. The highest frequency (62%) appeared during the postpartum period. The stages are higher in PABC, being 31.3% advanced (EIII and EIV) in PABC versus 13.3% in non-PABC (P < .05). Regarding prognostic factors, 27.3% in PABC had a tumoral grade 3 versus 15.8% of non-PABC. Among women with PABC, 33.3% had negative estrogen receptors, 48.7% negative progesterone receptors and 34.5% positive Her2Neu compared with 22.2, 24.1 and 31%, respectively of non-PABC patients. Finally, positive lymph nodes were found in 52.8% of PABC, versus 33.8% non-PABC (P < .05). Overall and disease-free survival rate at 5 years for PABC was 63.7 and 74.2%, respectively. The poorer survival observed is possibly due to the presence of adverse prognostic features such as lymph node metastases, negative hormone receptors, tumoral grade iii, as well as a delay in diagnosis with a higher rate of advanced stages. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  15. Southeast Atmosphere Studies: learning from model-observation syntheses

    Directory of Open Access Journals (Sweden)

    J. Mao

    2018-02-01

    Full Text Available Concentrations of atmospheric trace species in the United States have changed dramatically over the past several decades in response to pollution control strategies, shifts in domestic energy policy and economics, and economic development (and resulting emission changes elsewhere in the world. Reliable projections of the future atmosphere require models to not only accurately describe current atmospheric concentrations, but to do so by representing chemical, physical and biological processes with conceptual and quantitative fidelity. Only through incorporation of the processes controlling emissions and chemical mechanisms that represent the key transformations among reactive molecules can models reliably project the impacts of future policy, energy and climate scenarios. Efforts to properly identify and implement the fundamental and controlling mechanisms in atmospheric models benefit from intensive observation periods, during which collocated measurements of diverse, speciated chemicals in both the gas and condensed phases are obtained. The Southeast Atmosphere Studies (SAS, including SENEX, SOAS, NOMADSS and SEAC4RS conducted during the summer of 2013 provided an unprecedented opportunity for the atmospheric modeling community to come together to evaluate, diagnose and improve the representation of fundamental climate and air quality processes in models of varying temporal and spatial scales.This paper is aimed at discussing progress in evaluating, diagnosing and improving air quality and climate modeling using comparisons to SAS observations as a guide to thinking about improvements to mechanisms and parameterizations in models. The effort focused primarily on model representation of fundamental atmospheric processes that are essential to the formation of ozone, secondary organic aerosol (SOA and other trace species in the troposphere, with the ultimate goal of understanding the radiative impacts of these species in the southeast and

  16. A log rank type test in observational survival studies with stratified sampling.

    Science.gov (United States)

    Bai, Xiaofei; Tsiatis, Anastasios A

    2016-04-01

    In randomized clinical trials, the log rank test is often used to test the null hypothesis of the equality of treatment-specific survival distributions. In observational studies, however, the ordinary log rank test is no longer guaranteed to be valid. In such studies we must be cautious about potential confounders; that is, the covariates that affect both the treatment assignment and the survival distribution. In this paper, two cases were considered: the first is when it is believed that all the potential confounders are captured in the primary database, and the second case where a substudy is conducted to capture additional confounding covariates. We generalize the augmented inverse probability weighted complete case estimators for treatment-specific survival distribution proposed in Bai et al. (Biometrics 69:830-839, 2013) and develop the log rank type test in both cases. The consistency and double robustness of the proposed test statistics are shown in simulation studies. These statistics are then applied to the data from the observational study that motivated this research.

  17. The value of pragmatic and observational studies in health care and public health.

    Science.gov (United States)

    Barnish, Maxwell S; Turner, Steve

    2017-01-01

    Evidence-based practice is an important component of health care service delivery. However, there is a tendency, embodied in tools such as Grades of Recommendation, Assessment, Development, and Evaluation, to focus principally on the classification of study design, at the expense of a detailed assessment of the strengths and limitations of the individual study. Randomized controlled trials (RCTs), and in particular the classical "explanatory" RCT, have a privileged place in the hierarchy of evidence. However, classical RCTs have substantial limitations, most notably a lack of generalizability, which limit their direct applicability to clinical practice implementation. Pragmatic and observational studies can provide an invaluable perspective into real-world applicability. This evidence could be used more widely to complement ideal-condition results from classical RCTs, following the principle of triangulation. In this review article, we discuss several types of pragmatic and observational studies that could be used in this capacity. We discuss their particular strengths and how their limitations may be overcome and provide real-life examples by means of illustration.

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

    Science.gov (United States)

    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 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.

  19. Corticotherapy for traumatic brain-injured Patients - The Corti-TC trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Asehnoune Karim

    2011-10-01

    Full Text Available Abstract Background Traumatic brain injury (TBI is a main cause of severe prolonged disability of young patients. Hospital acquired pneumonia (HAP add to the morbidity and mortality of traumatic brain-injured patients. In one study, hydrocortisone for treatment of traumatic-induced corticosteroid insufficiency (CI in multiple injured patients has prevented HAP, particularly in the sub-group of patients with severe TBI. Fludrocortisone is recommended in severe brain-injured patients suffering from acute subarachnoid hemorrhage. Whether an association of hydrocortisone with fludrocortisone protects from HAP and improves neurological recovery is uncertain. The aim of the current study is to compare corticotherapy to placebo for TBI patients with CI. Methods The CORTI-TC (Corticotherapy in traumatic brain-injured patients trial is a multicenter, randomized, placebo controlled, double-blind, two-arms study. Three hundred and seventy six patients hospitalized in Intensive Care Unit with a severe traumatic brain injury (Glasgow Coma Scale ≤ 8 are randomized in the first 24 hours following trauma to hydrocortisone (200 mg.day-1 for 7 days, 100 mg on days 8-9 and 50 mg on day-10 with fludrocortisone (50 μg for 10 days or double placebo. The treatment is stopped if patients have an appropriate adrenal response. The primary endpoint is HAP on day-28. The endpoint of the ancillary study is the neurological status on 6 and 12 months. Discussion The CORTI-TC trial is the first randomized controlled trial powered to investigate whether hydrocortisone with fludrocortisone in TBI patients with CI prevent HAP and improve long term recovery. Trial registration NCT01093261

  20. The Healthy Steps Study: A randomized controlled trial of a pedometer-based Green Prescription for older adults. Trial protocol

    OpenAIRE

    Kolt, Gregory S; Schofield, Grant M; Kerse, Ngaire; Garrett, Nicholas; Schluter, Philip J; Ashton, Toni; Patel, Asmita

    2009-01-01

    Abstract Background Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. Methods/Design The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based...

  1. Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

    NARCIS (Netherlands)

    Buch, Maya H.; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K.; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S.; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

    2015-01-01

    Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task

  2. Gross Domestic Product (GDP and productivity of schizophrenia trials: an ecological study

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    Fenton Mark

    2003-12-01

    Full Text Available Abstract Background The 5000 randomised controlled trials (RCTs in the Cochrane Schizophrenia Group's database affords an opportunity to research for variables related to the differences between nations of their output of schizophrenia trials. Methods Ecological study – investigating the relationship between four economic/demographic variables and number of schizophrenia RCTs per country. The variable with closest correlation was used to predict the expected number of studies. Results GDP closely correlated with schizophrenia trial output, with 76% of the total variation about the Y explained by the regression line (r = 0.87, 95% CI 0.79 to 0.92, r2 = 0.76. Many countries have a strong tradition of schizophrenia trials, exceeding their predicted output. All nations with no identified trial output had GDPs that predicted zero trial activity. Several nations with relatively small GDPs are, nevertheless, highly productive of trials. Some wealthy countries seem either not to have produced the expected number of randomised trials or not to have disseminated them to the English-speaking world. Conclusions This hypothesis-generating study could not investigate causal relationships, but suggests, that for those seeking all relevant studies, expending effort searching the scientific literature of Germany, Italy, France, Brazil and Japan may be a good investment.

  3. Gross Domestic Product (GDP) and productivity of schizophrenia trials: an ecological study.

    Science.gov (United States)

    Moll, Carina; Gessler, Ursula; Bartsch, Stephanie; El-Sayeh, Hany George; Fenton, Mark; Adams, Clive Elliott

    2003-12-05

    The 5000 randomised controlled trials (RCTs) in the Cochrane Schizophrenia Group's database affords an opportunity to research for variables related to the differences between nations of their output of schizophrenia trials. Ecological study--investigating the relationship between four economic/demographic variables and number of schizophrenia RCTs per country. The variable with closest correlation was used to predict the expected number of studies. GDP closely correlated with schizophrenia trial output, with 76% of the total variation about the Y explained by the regression line (r = 0.87, 95% CI 0.79 to 0.92, r2 = 0.76). Many countries have a strong tradition of schizophrenia trials, exceeding their predicted output. All nations with no identified trial output had GDPs that predicted zero trial activity. Several nations with relatively small GDPs are, nevertheless, highly productive of trials. Some wealthy countries seem either not to have produced the expected number of randomised trials or not to have disseminated them to the English-speaking world. This hypothesis-generating study could not investigate causal relationships, but suggests, that for those seeking all relevant studies, expending effort searching the scientific literature of Germany, Italy, France, Brazil and Japan may be a good investment.

  4. A pilot study on the quality of data management in a cancer clinical trial

    NARCIS (Netherlands)

    Putten, E. van der; Velden, J.W. van der; Siers, A.; Hamersma, E.A.M.

    Twelve institutional data managers were asked to independently code the data from a patient chart of one patient in an ovarian cancer trial. They abstracted data from the medical record and filled out three types of trial forms (on-study, chemotherapy, and summary forms). The analysis of the

  5. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  6. Evaluation of biases present in the cohort multiple randomised controlled trial design: a simulation study

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    Jane Candlish

    2017-01-01

    Full Text Available Abstract Background The cohort multiple randomised controlled trial (cmRCT design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key concern of the cmRCT design: refusal to treatment is only present in the intervention arm, and this may lead to bias and reduce statistical power. Methods We used simulation studies to assess the effect of this refusal, both random and related to event risk, on bias of the effect estimator and statistical power. A series of simulations were undertaken that represent a cmRCT trial with time-to-event endpoint. Intention-to-treat (ITT, per protocol (PP, and instrumental variable (IV analysis methods, two stage predictor substitution and two stage residual inclusion, were compared for various refusal scenarios. Results We found the IV methods provide a less biased estimator for the causal effect when refusal is present in the intervention arm, with the two stage residual inclusion method performing best with regards to minimum bias and sufficient power. We demonstrate that sample sizes should be adapted based on expected and actual refusal rates in order to be sufficiently powered for IV analysis. Conclusion We recommend running both an IV and ITT analyses in an individually randomised cmRCT as it is expected that the effect size of interest, or the effect we would observe in clinical practice, would lie somewhere between that estimated with ITT and IV analyses. The optimum (in terms of bias and power instrumental variable method was the two stage residual inclusion method. We recommend using adaptive power calculations, updating them as refusal rates are collected in the trial recruitment phase in order to be sufficiently powered for IV analysis.

  7. Conducting feasibilities in clinical trials: An investment to ensure a good study

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    Viraj Rajadhyaksha

    2010-01-01

    Full Text Available Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  8. Sponsors’ participation in conduct and reporting of industry trials: a descriptive study

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    Lundh Andreas

    2012-08-01

    Full Text Available Abstract Background Bias in industry-sponsored trials is common and the interpretation of the results can be particularly distorted in favour of the sponsor’s product. We investigated sponsors’ involvement in the conduct and reporting of industry-sponsored trials. Methods We included all industry-sponsored trials published in The Lancet in 2008 and 2009 and corresponding trial protocols provided by The Lancet. For each protocol and publication, we extracted information on trial conduct and reporting. Results We identified 169 publications of randomised trials and included 69 (41% that were industry-sponsored, and 12 (7% industry-funded but seemingly independently conducted as a subsample. Entry of data into the study database was done independently by academic authors without the involvement of the sponsor or a contract research organisation in one of the 69 trials. Two trials had independent data analysis and one independent reporting of results. In 11 of the trials, there was a discrepancy between the information in the protocols and papers concerning who analysed the data. In four of the 12 seemingly independent trials, the protocol described sponsors’ involvement in writing the report while the published paper explicitly stated that the sponsor was not involved. Conclusions The sponsors are usually involved in the analysis and reporting of results in industry-sponsored trials, but their exact role is not always clear from the published papers. Journals should require more transparent reporting of the sponsors’ role in crucial elements such as data processing, statistical analysis and writing of the manuscript and should consider requiring access to trial protocols, independent data analysis and submission of the raw data.

  9. No short-cut in assessing trial quality: a case study

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    Hirji Karim F

    2009-01-01

    Full Text Available Abstract Background Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. Results The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991 is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. Conclusion A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

  10. Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Weller, Carolina D; Barker, Anna; Darby, Ian; Haines, Terrence; Underwood, Martin; Ward, Stephanie; Aldons, Pat; Dapiran, Elizabeth; Madan, Jason J; Loveland, Paula; Sinha, Sankar; Vicaretti, Mauro; Wolfe, Rory; Woodward, Michael; McNeil, John

    2016-04-11

    Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing. This randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks. The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018. Australian New Zealand Clinical Trials Registry, ACTRN12614000293662.

  11. Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring

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    Karen Day

    2016-06-01

    Full Text Available Abstract Background Action research (AR and randomized controlled trials (RCTs are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. Methods Data came from authors’ observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban, airways disease (Site B, urban, and diabetes (Site C, rural. The research ran from 2008 (project inception until 2012 (project close-off. Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing. Results We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger

  12. Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study

    Science.gov (United States)

    Background: The role of low dose methotrexate (LDM) in potential serious toxicities remains unclear despite its common use. Prior observational studies investigating LDM toxicity compared LDM to other active drugs. Prior placebo-controlled clinical trials of LDM in inflammatory conditions were not l...

  13. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

    Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

  14. The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project

    Science.gov (United States)

    Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso; Legocki, Laurie J; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

    2017-01-01

    Objectives: Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients with disease. Adaptive clinical trials have emerged as a methodology to provide more flexibility in design elements to better answer scientific questions regarding whether new treatments are efficacious. Limited observational data exist that describe the complex process of designing adaptive clinical trials. To address these issues, the Adaptive Designs Accelerating Promising Treatments Into Trials project developed six, tailored, flexible, adaptive, phase-III clinical trials for neurological emergencies, and investigators prospectively monitored and observed the processes. The objective of this work is to describe the adaptive design development process, the final design, and the current status of the adaptive trial designs that were developed. Methods: To observe and reflect upon the trial development process, we employed a rich, mixed methods evaluation that combined quantitative data from visual analog scale to assess attitudes about adaptive trials, along with in-depth qualitative data about the development process gathered from observations. Results: The Adaptive Designs Accelerating Promising Treatments Into Trials team developed six adaptive clinical trial designs. Across the six designs, 53 attitude surveys were completed at baseline and after the trial planning process completed. Compared to baseline, the participants believed significantly more strongly that the adaptive designs would be accepted by National Institutes of Health review panels and non-researcher clinicians. In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies. Conclusion: Introducing the adaptive design at early conceptualization proved critical to successful adoption and implementation of that trial. Involving key

  15. The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project.

    Science.gov (United States)

    Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso; Legocki, Laurie J; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

    2017-01-01

    Clinical trials are complicated, expensive, time-consuming, and frequently do not lead to discoveries that improve the health of patients with disease. Adaptive clinical trials have emerged as a methodology to provide more flexibility in design elements to better answer scientific questions regarding whether new treatments are efficacious. Limited observational data exist that describe the complex process of designing adaptive clinical trials. To address these issues, the Adaptive Designs Accelerating Promising Treatments Into Trials project developed six, tailored, flexible, adaptive, phase-III clinical trials for neurological emergencies, and investigators prospectively monitored and observed the processes. The objective of this work is to describe the adaptive design development process, the final design, and the current status of the adaptive trial designs that were developed. To observe and reflect upon the trial development process, we employed a rich, mixed methods evaluation that combined quantitative data from visual analog scale to assess attitudes about adaptive trials, along with in-depth qualitative data about the development process gathered from observations. The Adaptive Designs Accelerating Promising Treatments Into Trials team developed six adaptive clinical trial designs. Across the six designs, 53 attitude surveys were completed at baseline and after the trial planning process completed. Compared to baseline, the participants believed significantly more strongly that the adaptive designs would be accepted by National Institutes of Health review panels and non-researcher clinicians. In addition, after the trial planning process, the participants more strongly believed that the adaptive design would meet the scientific and medical goals of the studies. Introducing the adaptive design at early conceptualization proved critical to successful adoption and implementation of that trial. Involving key stakeholders from several scientific domains early

  16. Observational study of drug-drug interactions in oncological inpatients

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    María Sacramento Díaz-Carrasco

    2018-01-01

    Full Text Available Objective: To determine the prevalence of potential clinically relevant drug- drug interactions in adult oncological inpatients, as well as to describe the most frequent interactions. A standard database was used. Method: An observational, transversal, and descriptive study including patients admitted to the Oncology Service of a reference hospital. All prescriptions were collected twice a week during a month. They were analysed using Lexicomp® database, recording all interactions classified with a level of risk: C, D or X. Results: A total of 1 850 drug-drug interactions were detected in 218 treatments. The prevalence of treatments with at least one clinically relevant interaction was 95%, being 94.5% for those at level C and 26.1% for levels D and X. The drugs most commonly involved in the interactions detected were opioid analgesics, antipsychotics (butyrophenones, benzodiazepines, pyrazolones, glucocorticoids and heparins, whereas interactions with antineoplastics were minimal, highlighting those related to paclitaxel and between metamizole and various antineoplastics. Conclusions: The prevalence of clinically relevant drug-drug interactions rate was very high, highlighting the high risk percentage of them related to level of risk X. Due to the frequency of onset and potential severity, highlighted the concomitant use of central nervous system depressants drugs with risk of respiratory depression, the risk of onset of anticholinergic symptoms when combining morphine or haloperidol with butylscopolamine, ipratropium bromide or dexchlorpheniramine and the multiple interactions involving metamizole.

  17. Young adult smoking in peer groups: an experimental observational study.

    Science.gov (United States)

    Harakeh, Zeena; Vollebergh, Wilma A M

    2013-03-01

    The aim of this experimental observational study is to examine whether, in a group setting (same-sex triads), passive peer influence (imitation) in the context of homogeneous and heterogeneous (contradictory) behavior of peer models affects young adults' smoking behavior. An experiment was conducted among 48 daily-smoking college and university students aged 17-25. Participants had to complete a 30-min music task with two same-sex confederates. We tested the following three conditions: (a) neither of the confederates is smoking, (b) one confederate is smoking and the other is not, and (c) both confederates are smoking. The primary outcome tested was the total number of cigarettes smoked during the task. Students in the condition with two smoking peer models and in the condition with one smoking peer model and one nonsmoking peer model smoked significantly more cigarettes than those in the condition with two nonsmoking peer models. However, results for the condition with two smoking peer models did not differ significantly from the condition with one smoking peer model and one nonsmoking peer model. Our findings show that in a group setting, the impact of the homogeneity of smoking peers on young adults' smoking behavior is not greater than the impact of the heterogeneity of smoking and nonsmoking peers. This would suggest that the smoking peer in the group has a greater impact on the daily-smoking young adult, thus reducing or even eliminating the protective effect of the nonsmoking peer model.

  18. iPad use during ward rounds: an observational study.

    Science.gov (United States)

    Lehnbom, Elin C; Adams, Kristian; Day, Richard O; Westbrook, Johanna I; Baysari, Melissa T

    2014-01-01

    Much clinical information is computerised and doctors' use of mobile devices such as iPad tablets to access this information is expanding rapidly. This study investigated the use of iPads during ward rounds and their usefulness in providing access to information during ward rounds. Ten teams of doctors at a large teaching hospital were given iPads for ten weeks and were observed on ward rounds for 77.3 hours as they interacted with 525 patients. Use of iPads and other information technology devices to access clinical information was recorded. The majority of clinical information was accessed using iPads (56.2%), followed by computers-on-wheels (35.8%), stationary PCs (7.9%) and smartphones (0.1%). Despite having read-only access on iPads, doctors were generally happy using iPads on ward rounds. These findings provide evidence of the value of iPads as a tool to access information at the point of care.

  19. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study).

    Science.gov (United States)

    Gehring, Marta; Taylor, Rod S; Mellody, Marie; Casteels, Brigitte; Piazzi, Angela; Gensini, Gianfranco; Ambrosio, Giuseppe

    2013-11-15

    Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001). Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical

  20. Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

    Science.gov (United States)

    Ma, Handong; Weng, Chunhua

    2016-04-01

    To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

  1. A pragmatic observational feasibility study on integrated treatment for musculoskeletal disorders: Design and protocol.

    Science.gov (United States)

    Hu, Xiao-yang; Hughes, John; Fisher, Peter; Lorenc, Ava; Purtell, Rachel; Park, A-La; Robinson, Nicola

    2016-02-01

    Musculoskeletal disorders (MSD) comprise a wide range of conditions, associated with an enormous pain and impaired mobility, and are affecting people's lives and work. Management of musculoskeletal disorders typically involves a multidisciplinary team approach. Positive findings have been found in previous studies evaluating the effectiveness of complementary therapies, though little attention has been paid to evaluating of the effectiveness of integrated packages of care combining conventional and complementary approaches for musculoskeletal conditions in a National Health Service (NHS) setting. To determine the feasibility of all aspects of a pragmatic observational study designed: (1) to evaluate the effectiveness and cost effectiveness of integrated treatments for MSDs in an integrated NHS hospital in the UK; (2) to determine the acceptability of the study design and research process to patients; (3) to explore patients' expectation and experience of receiving integrated treatments. This is an observational feasibility study, with 1-year recruitment and 1-year follow-up, conducted in Royal London Hospital for Integrated Medicine, University College London Hospital Trust, UK. All eligible patients with MSDs newly referred to the hospital were included in the study. Interventions are integrated packages of care (conventional and complementary) as currently provided in the hospital. SF-36™ Health Survey, short form Brief Pain Inventory, Visual Analogue Scale, and modified Client Service Receipt Inventory will be assessed at 4/5 time points. Semi-structured interview/focus group will be carried out before treatment, and 1 year after commence of treatment. We intend to conduct a pragmatic observational study of integrated medical treatment of MSDs at a public sector hospital. It will inform the design of a future trial including recruitment, retention, suitability of the outcome measures and patients experiences.

  2. Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis

    NARCIS (Netherlands)

    Daniels, L.; de Korte, N.; van Dieren, S.; Stockmann, H. B.; Vrouenraets, B. C.; Consten, E. C.; van der Hoeven, J. A.; Eijsbouts, Q. A.; Faneyte, I. F.; Bemelman, W. A.; Dijkgraaf, M. G.; Boermeester, M. A.; Glaap, C. E M; Croonen, A.; Cuesta, M. A.; Kuijvenhoven, J.; Buijsman, R.; Den Uil, S.; De Reuver, P. R.; Tuynman, J. B.; Van de Wall, B. J M; Stam, M. A W; Roumen, R. M H; Truin, W.; Wijn, R.; Gerhards, M. F.; Kuhlmann, K. F D; Van der Zaag, E. S.; Biemond, J. E.; Klicks, R. J.; Dhar, N.; Cense, H. A.; De Groot, G. H.; Pikoulin, Y.; Van Ramshorst, G. H.; Hoornweg, L. L.; Koet, L.; Van Geloven, A. A W; Emous, M.; Claassen, A. T P M; Mollink, S.; Sonneveld, D. J A; Bouvé, L.; Diepenhorst, G. M P; Vles, W. J.; Toorenvliet, B. R.; Lange, J. F.; Mannaerts, G. H H; Grotenhuis, B. A.; tot Nederveen Cappel, R. J De Vos; Deerenberg, E. B.; Depla, A. C T M; Bruin, S.; Vos, X.; Scheepers, J. J G; Boom, M. J.; Boerma, D.; Van Esser, S.; Pruim, J.; Reitsma, J. B.

    Background: Antibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis. Methods: Patients with

  3. Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT-proven uncomplicated acute diverticulitis

    NARCIS (Netherlands)

    Daniels, L.; Unlu, C.; Korte, N. de; Dieren, S. van; Stockmann, H.B.; Vrouenraets, B.C.; Consten, E.C.; Hoeven, J.A. van der; Eijsbouts, Q.A.; Faneyte, I.F.; Bemelman, W.A.; Dijkgraaf, M.G.; Boermeester, M.A.; Reuver, P.R.; et al.,

    2017-01-01

    BACKGROUND: Antibiotics are advised in most guidelines on acute diverticulitis, despite a lack of evidence to support their routine use. This trial compared the effectiveness of a strategy with or without antibiotics for a first episode of uncomplicated acute diverticulitis. METHODS: Patients with

  4. Rapid Protective Effects of Early BCG on Neonatal Mortality Among Low Birth Weight Boys: Observations From Randomized Trials.

    Science.gov (United States)

    Biering-Sørensen, Sofie; Jensen, Kristoffer Jarlov; Monterio, Ivan; Ravn, Henrik; Aaby, Peter; Benn, Christine Stabell

    2018-02-14

    Three randomized trials (RCTs) in low-weight (BCG) vaccine nonspecifically reduces all-cause mortality in the neonatal period. Using data from 3 RCTs of early BCG (n = 6583) we examined potential sex differences in the timing of the mortality reduction in the neonatal period, presenting metaestimates of the main outcome mortality rate ratios (MRR) for BCG-vaccinated and controls. Among controls, boys had a particularly high mortality during the first week after randomization: male-female MRR 2.71 (95% CI, 1.70-4.50). During the first week, BCG had a marked beneficial effect for boys, reducing mortality 3-fold (MRR [BCG/no BCG] = 0.36 [0.20-0.67]). In weeks 2-4 the effect waned for boys (MRR = 0.91 [0.51-1.69]). In girls, the pattern was opposite with a limited effect in the first week (MRR = 0.85 [0.46-1.54]), but a significant reduction in weeks 2-4 (MRR = 0.56 [0.31-1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys. The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance of providing BCG soon after birth. ClinicalTrials.gov (NCT00146302) and ClinicalTrials.gov (NCT00625482).

  5. Uptake of an innovation in surgery: observations from the cluster-randomized Quality Initiative in Rectal Cancer trial.

    Science.gov (United States)

    Simunovic, Marko; Coates, Angela; Smith, Andrew; Thabane, Lehana; Goldsmith, Charles H; Levine, Mark N

    2013-12-01

    Theory suggests the uptake of a medical innovation is influenced by how potential adopters perceive innovation characteristics and by characteristics of potential adopters. Innovation adoption is slow among the first 20% of individuals in a target group and then accelerates. The Quality Initiative in Rectal Cancer (QIRC) trial assessed if rectal cancer surgery outcomes could be improved through surgeon participation in the QIRC strategy. We tested if traditional uptake of innovation concepts applied to surgeons in the experimental arm of the trial. The QIRC strategy included workshops, access to opinion leaders, intraoperative demonstrations, postoperative questionnaires, and audit and feedback. For intraoperative demonstrations, a participating surgeon invited an outside surgeon to demonstrate optimal rectal surgery techniques. We used surgeon timing in a demonstration to differentiate early and late adopters of the QIRC strategy. Surgeons completed surveys on perceptions of the strategy and personal characteristics. Nineteen of 56 surgeons (34%) requested an operative demonstration on their first case of rectal surgery. Early and late adopters had similar perceptions of the QIRC strategy and similar characteristics. Late adopters were less likely than early adopters to perceive an advantage for the surgical techniques promoted by the trial (p = 0.023). Most traditional diffusion of innovation concepts did not apply to surgeons in the QIRC trial, with the exception of the importance of perceptions of comparative advantage.

  6. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

    2016-01-01

    To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  7. [The aggression in SPDC: an observational study. Preliminary data].

    Science.gov (United States)

    Minutolo, Giuseppe; Cannavò, Dario; Petralia, Antonino; Gandolfo, Liliana; Palermo, Filippo; Aguglia, Eugenio

    2010-01-01

    In the different psychiatric disorders the aggression often leads to uncontrolled events, taking aspects of impulsiveness and irrationality. Our research proposes the assessment of socio-demographic and clinical characteristics of patients with a psychiatric disorder, who presented an aggressive event. The observational study was conducted on a sample of 50 patients (34 men and 16 women), hospitalized following the manifestation of an aggressive event. For each patient was provided an assessment of socio-demographic and clinical variables and a psychometric investigation through: the OAS, for the analysis of aggressive episodes; the BDHI, for the hostile behavior and attitudes; the BIS-11, for the impulsiveness and the BPRS for the psychopathological aspects. Among the socio-demographic features investigated, the highest correlation with aggressive behavior was related to the concomitant substance abuse, type of admission to psychiatric hospital and the male gender. The OAS has shown a greater propensity to directed-aggression in males with schizophrenia, and self-directed in females with major depression. The BPRS has shown a positive correlation between hetero-directed aggressive behavior and positive symptomatology, and between the self-directed and depression, risk of suicide, feelings of guilt and somatic concerns. The BDHI has indicated greater suspicion in women's group. The hypothesis that aggression is otherwise related to specific socio-demographic and clinical characteristics was confirmed by our study. The data suggest that early identification and assessment of potential risk factors involved in the genesis of aggressive episodes would allow the clinician to implement a better strategy for prevention and intervention.

  8. External Validation of the HERNIAscore: An Observational Study.

    Science.gov (United States)

    Cherla, Deepa V; Moses, Maya L; Mueck, Krislynn M; Hannon, Craig; Ko, Tien C; Kao, Lillian S; Liang, Mike K

    2017-09-01

    The HERNIAscore is a ventral incisional hernia (VIH) risk assessment tool that uses only preoperative variables and predictable intraoperative variables. The aim of this study was to validate and modify, if needed, the HERNIAscore in an external dataset. This was a retrospective observational study of all patients undergoing resection for gastrointestinal malignancy from 2011 through 2015 at a safety-net hospital. The primary end point was clinical postoperative VIH. Patients were stratified into low-risk, medium-risk, and high-risk groups based on HERNIAscore. A revised HERNIAscore was calculated with the addition of earlier abdominal operation as a categorical variable. Cox regression of incisional hernia with stratification by risk class was performed. Incidence rates of clinical VIH formation within each risk class were also calculated. Two hundred and forty-seven patents were enrolled. On Cox regression, in addition to the 3 variables of the HERNIAscore (BMI, COPD, and incision length), earlier abdominal operation was also predictive of VIH. The revised HERNIAscore demonstrated improved predictive accuracy for clinical VIH. Although the original HERNIAscore effectively stratified the risk of an incisional radiographic VIH developing, the revised HERNIAscore provided a statistically significant stratification for both clinical and radiographic VIHs in this patient cohort. We have externally validated and improved the HERNIAscore. The revised HERNIAscore uses BMI, incision length, COPD, and earlier abdominal operation to predict risk of postoperative incisional hernia. Future research should assess methods to prevent incisional hernias in moderate-to-high risk patients. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Pascal H Colson

    Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  10. Fatal poisonings in Oslo: a one-year observational study

    Directory of Open Access Journals (Sweden)

    Heyerdahl Fridtjof

    2010-06-01

    Full Text Available Abstract Background Acute poisonings are common and are treated at different levels of the health care system. Since most fatal poisonings occur outside hospital, these must be included when studying characteristics of such deaths. The pattern of toxic agents differs between fatal and non-fatal poisonings. By including all poisoning episodes, cause-fatality rates can be calculated. Methods Fatal and non-fatal acute poisonings in subjects aged ≥16 years in Oslo (428 198 inhabitants were included consecutively in an observational multi-centre study including the ambulance services, the Oslo Emergency Ward (outpatient clinic, and hospitals, as well as medico-legal autopsies from 1st April 2003 to 31st March 2004. Characteristics of fatal poisonings were examined, and a comparison of toxic agents was made between fatal and non-fatal acute poisoning. Results In Oslo, during the one-year period studied, 103 subjects aged ≥16 years died of acute poisoning. The annual mortality rate was 24 per 100 000. The male-female ratio was 2:1, and the mean age was 44 years (range 19-86 years. In 92 cases (89%, death occurred outside hospital. The main toxic agents were opiates or opioids (65% of cases, followed by ethanol (9%, tricyclic anti-depressants (TCAs (4%, benzodiazepines (4%, and zopiclone (4%. Seventy-one (69% were evaluated as accidental deaths and 32 (31% as suicides. In 70% of all cases, and in 34% of suicides, the deceased was classified as drug or alcohol dependent. When compared with the 2981 non-fatal acute poisonings registered during the study period, the case fatality rate was 3% (95% C.I., 0.03-0.04. Methanol, TCAs, and antihistamines had the highest case fatality rates; 33% (95% C.I., 0.008-0.91, 14% (95% C.I., 0.04-0.33, and 10% (95% C.I., 0.02-0.27, respectively. Conclusions Three per cent of all acute poisonings were fatal, and nine out of ten deaths by acute poisonings occurred outside hospital. Two-thirds were evaluated as accidental

  11. Modified release paracetamol overdose: a prospective observational study (ATOM-3).

    Science.gov (United States)

    Chiew, Angela L; Isbister, Geoffrey K; Page, Colin B; Kirby, Katharine A; Chan, Betty S H; Buckley, Nicholas A

    2018-02-16

    Modified-release (MR) paracetamol is available in many countries as 665 mg tablets of which 69% is MR and 31% is immediate release. There are concerns that MR paracetamol overdose has higher rates of liver injury despite standard treatment algorithms. The objective of this study was to describe the clinical characteristics and outcomes of acute MR paracetamol overdose. Prospective observational study, recruiting patients from January 2013 to June 2017, from five clinical toxicology units and calls to two Poisons Information Centres in Australia. Included were patients >14 years who ingested ≥10 g or 200 mg/kg (whichever is less) of MR paracetamol. Data collected included demographics, ingestion history, pathology results, treatments, and outcomes including hepatotoxicity (ALT >1000 U/L). In total, 116 patients were recruited, 85(73%) were female. The median dose ingested was 32 g (IQR: 20-49 g) and median time to presentation was 3 h (IQR: 2-9 h). 78(67%) had an initial paracetamol concentration above the nomogram line (150 mg/L at 4 h). A further 12(10%) crossed the nomogram after repeat paracetamol measurements, of which five crossed after two non-toxic levels 4 h apart. Six had a double paracetamol peak, in three occurring >24 h post-ingestion. 113(97%) received acetylcysteine of which 67 received prolonged treatment beyond the standard 21 h. This was because of an elevated paracetamol concentration at the completion of acetylcysteine in 39 (median paracetamol concentration 25 mg/L, IQR: 16-62 mg/L). 21 (18%) developed hepatotoxicity, including six treated within 8 h of ingestion. Activated charcoal and double doses of acetylcysteine did not significantly decrease the risk of hepatotoxicity. Drug regulatory authorities are considering restrictions on MR paracetamol preparations. Following an acute MR paracetamol overdose, this study found that many patients had a persistently elevated paracetamol concentrations, many required

  12. Fatal poisonings in Oslo: a one-year observational study.

    Science.gov (United States)

    Bjornaas, Mari A; Teige, Brita; Hovda, Knut E; Ekeberg, Oivind; Heyerdahl, Fridtjof; Jacobsen, Dag

    2010-06-06

    Acute poisonings are common and are treated at different levels of the health care system. Since most fatal poisonings occur outside hospital, these must be included when studying characteristics of such deaths. The pattern of toxic agents differs between fatal and non-fatal poisonings. By including all poisoning episodes, cause-fatality rates can be calculated. Fatal and non-fatal acute poisonings in subjects aged > or =16 years in Oslo (428 198 inhabitants) were included consecutively in an observational multi-centre study including the ambulance services, the Oslo Emergency Ward (outpatient clinic), and hospitals, as well as medico-legal autopsies from 1st April 2003 to 31st March 2004. Characteristics of fatal poisonings were examined, and a comparison of toxic agents was made between fatal and non-fatal acute poisoning. In Oslo, during the one-year period studied, 103 subjects aged > or =16 years died of acute poisoning. The annual mortality rate was 24 per 100 000. The male-female ratio was 2:1, and the mean age was 44 years (range 19-86 years). In 92 cases (89%), death occurred outside hospital. The main toxic agents were opiates or opioids (65% of cases), followed by ethanol (9%), tricyclic anti-depressants (TCAs) (4%), benzodiazepines (4%), and zopiclone (4%). Seventy-one (69%) were evaluated as accidental deaths and 32 (31%) as suicides. In 70% of all cases, and in 34% of suicides, the deceased was classified as drug or alcohol dependent. When compared with the 2981 non-fatal acute poisonings registered during the study period, the case fatality rate was 3% (95% C.I., 0.03-0.04). Methanol, TCAs, and antihistamines had the highest case fatality rates; 33% (95% C.I., 0.008-0.91), 14% (95% C.I., 0.04-0.33), and 10% (95% C.I., 0.02-0.27), respectively. Three per cent of all acute poisonings were fatal, and nine out of ten deaths by acute poisonings occurred outside hospital. Two-thirds were evaluated as accidental deaths. Although case fatality rates were

  13. Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Band, Margaret M; Sumukadas, Deepa; Struthers, Allan D; Avenell, Alison; Donnan, Peter T; Kemp, Paul R; Smith, Karen T; Hume, Cheryl L; Hapca, Adrian; Witham, Miles D

    2018-01-04

    Sarcopenia (the age-related loss of muscle mass and function) is a major contributor to loss of mobility, falls, loss of independence, morbidity and mortality in older people. Although resistance training is effective in preventing and reversing sarcopenia, many older people are sedentary and either cannot or do not want to exercise. This trial examines the efficacy of supplementation with the amino acid leucine and/or angiotensin converting enzyme inhibition to potentially improve muscle mass and function in people with sarcopenia. Promising preliminary data exist from small studies for both interventions, but neither has yet been tested in adequately powered randomised trials in patients with sarcopenia. Leucine and ACE inhibitors in sarcopenia (LACE) is a multicentre, masked, placebo-controlled, 2 × 2 factorial randomised trial evaluating the efficacy of leucine and perindopril (angiotensin converting enzyme inhibitor (ACEi)) in patients with sarcopenia. The trial will recruit 440 patients from primary and secondary care services across the UK. Male and female patients aged 70 years and over with sarcopenia as defined by the European Working Group on Sarcopenia (based on low total skeletal muscle mass on bioimpedance analysis and either low gait speed or low handgrip strength) will be eligible for participation. Participants will be excluded if they have a contraindication to, or are already taking, an ACEi, angiotensin receptor blocker or leucine. The primary clinical outcome for the trial is the between-group difference in the Short Physical Performance Battery score at all points between baseline and 12 months. Secondary outcomes include appendicular muscle mass measured using dual-energy X-ray absorptiometry, muscle strength, activities of daily living, quality of life, activity using pedometer step counts and falls. Participants, clinical teams, outcomes assessors and trial analysts are masked to treatment allocation. A panel of biomarkers including

  14. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    International Nuclear Information System (INIS)

    Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

    2011-01-01

    Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

  15. Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pérez-Mármol, Jose Manuel; García-Ríos, M Carmen; Barrero-Hernandez, Francisco J; Molina-Torres, Guadalupe; Brown, Ted; Aguilar-Ferrándiz, María Encarnación

    2015-11-05

    Upper limb apraxia is a common disorder associated with stroke that can reduce patients' independence levels in activities of daily living and increase levels of disability. Traditional rehabilitation programs designed to promote the recovery of upper limb function have mainly focused on restorative or compensatory approaches. However, no previous studies have been completed that evaluate a combined intervention method approach, where patients concurrently receive cognitive training and learn compensatory strategies for enhancing daily living activities. This study will use a two-arm, assessor-blinded, parallel, randomized controlled trial design, involving 40 patients who present a left- or right-sided unilateral vascular lesion poststroke and a clinical diagnosis of upper limb apraxia. Participants will be randomized to either a combined functional rehabilitation or a traditional health education group. The experimental group will receive an 8-week combined functional program at home, including physical and occupational therapy focused on restorative and compensatory techniques for upper limb apraxia, 3 days per week in 30-min intervention periods. The control group will receive a conventional health education program once a month over 8 weeks, based on improving awareness of physical and functional limitations and facilitating the adaptation of patients to the home. Study outcomes will be assessed immediately postintervention and at the 2-month follow-up. The primary outcome measure will be basic activities of daily living skills as assessed with the Barthel Index. Secondary outcome measures will include the following: 1) the Lawton and Brody Instrumental Activities of Daily Living Scale, 2) the Observation and Scoring of ADL-Activities, 3) the De Renzi Test for Ideational Apraxia, 4) the De Renzi Test for Ideomotor Apraxia, 5) Recognition of Gestures, 6) the Test of Upper Limb Apraxia (TULIA), and 7) the Quality of Life Scale For Stroke (ECVI-38). This trial is

  16. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study

    Directory of Open Access Journals (Sweden)

    Latimer Nicholas

    2011-01-01

    Full Text Available Abstract Background We investigate methods used to analyse the results of clinical trials with survival outcomes in which some patients switch from their allocated treatment to another trial treatment. These included simple methods which are commonly used in medical literature and may be subject to selection bias if patients switching are not typical of the population as a whole. Methods which attempt to adjust the estimated treatment effect, either through adjustment to the hazard ratio or via accelerated failure time models, were also considered. A simulation study was conducted to assess the performance of each method in a number of different scenarios. Results 16 different scenarios were identified which differed by the proportion of patients switching, underlying prognosis of switchers and the size of true treatment effect. 1000 datasets were simulated for each of these and all methods applied. Selection bias was observed in simple methods when the difference in survival between switchers and non-switchers were large. A number of methods, particularly the AFT method of Branson and Whitehead were found to give less biased estimates of the true treatment effect in these situations. Conclusions Simple methods are often not appropriate to deal with treatment switching. Alternative approaches such as the Branson & Whitehead method to adjust for switching should be considered.

  17. Study design issues in trials among children with MAM

    International Nuclear Information System (INIS)

    Friis, Henrik

    2014-01-01

    There is a need for acceptable and affordable food aid products for children with moderate acute malnutrition (MAM), which effectively restore body tissues and functions. The effects of potential products need to be assessed through randomised controlled trials (RCT). However, nutritional RCTs pose ethical and scientific challenges. Control groups are usually given “standard of care”, but recommendations for treatment do not exist in all settings or supplements are not always available. In places where treatment is nonexistent, not giving any food to children in the control group is not without ethical concerns. However, from public health and scientific perspectives, it is problematic to compare with supplements which are not recommended or the effect of which is unknown. Firstly, it is of questionable value for a low-income country that a trial is conducted to compare an experimental supplement to a supplement that is not already standard of care, and national ethics committees may not grant permission for such a trial. Secondly, it is difficult to interpret findings from a trial comparing an experimental supplement to one that has not been properly tested. Hence, where supplementation is not standard of care, it may be ethically justifiable to have an unsupplemented control group. In such cases, mothers should receive health education and the children should receive medical attention, be monitored closely, and referred for further medical examination and treatment if not recovering. Delayed supplementation may also be considered. Food interventions are complex, since supplements with the same energy content may be based on different ingredients, and nutrients in different forms and amounts. Consequently, there are an infinite number of potential food supplements, yet only a few can be tested in trials. Some components may be potentially important, but costly. If several factors are of interest, then a factorial design may be needed. E.g. the treatFOOD trial

  18. Southeast Atmosphere Studies: learning from model-observation syntheses

    Data.gov (United States)

    U.S. Environmental Protection Agency — Observed and modeled data shown in figure 2b-c. This dataset is associated with the following publication: Mao, J., A. Carlton, R. Cohen, W. Brune, S. Brown, G....

  19. Pulp polyp - A periapical lesion: Radiographic observational study

    Directory of Open Access Journals (Sweden)

    Kandagal V Suresh

    2015-01-01

    Full Text Available Introduction: Pulp polyp (PP is a chronic hyperplastic condition resulting in formation of granulation tissue and proliferative mass. The radiographic appearance of PP has innumerable presentations. Diagnosing and treatment planning of periapical lesions, heavily relies on the radiographic changes surrounding the root structures. Objective: To evaluate different radiographic periapical changes in clinically detected PP patients. Materials and Methods: Patients reporting to Department of Oral Medicine and Radiology and who were clinically diagnosed with PP by an oral diagnostician were subjected to radiographic examination. Digital intraoral periapical radiographs of 50 patients with PP were taken. Various periapical changes in the digital radiographs were recorded by a skilled oral radiologist. The data obtained was subjected to statistical analysis using SPSS ver 17.0 and P-value was set at <0.05 as significant. Result: Periapical changes like periodontal space widening (PDLW, loss of lamina dura, periapical abscess, periapical granuloma, hypercementosis, condensing osteitis and root resorption were noted. Periodontal space widening was seen in all patients (100%, loss of lamina dura was noted in 72%, periapical rarefying osteitis in 56%, condensing osteitis in 8%, hypercementosis, periapical granuloma, and root resorption were seen in 4% of PP patients. Majority of PP were asymptomatic (66%. Pulp polyp was commonly seen in mandibular first molar followed by mandibular second molar and maxillary first molar. Statistically significant difference was noticed between periapical changes in PP patients (P value <0.0001. All PP patients showed definite periapical changes suggesting it to be a periapical lesion. Conclusion: Pulp polyp is confined to the pulpal portion of the tooth which, may or may not cause changes in periapical region. The results of the present study showed that majority of the PP patients were associated with definite periapical

  20. Multicentre observational study of the Gatekeeper for faecal incontinence.

    Science.gov (United States)

    Ratto, C; Buntzen, S; Aigner, F; Altomare, D F; Heydari, A; Donisi, L; Lundby, L; Parello, A

    2016-02-01

    A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up. Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up. © 2015 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

  1. Managing acute alcohol withdrawal with Homoeopathy: A prospective, observational, multicentre exploratory study

    Directory of Open Access Journals (Sweden)

    Debadatta Nayak

    2014-01-01

    Full Text Available Background: Alcohol dependence is a common social problem which may be associated with other risk factors and co-morbidities. Abrupt cessation of alcohol intake may provoke an acute alcohol withdrawal phase with varying degrees of signs and symptoms. In conventional medical system, specific pharmacological interventions are used for management of Acute Alcohol Withdrawal (AAW. There exists a need to explore safe and holistic treatment of AAW. The present work reports the results of a prospective, observational, exploratory, multicentre trial (2008-2011 to assess the role of Homoeopathy in AAW. Materials and Methods: Individualised Homoeopathy was given to 112 patients reporting with AAW. The clinical assessment was done for 05 days using Clinical Institute Withdrawal Assessment Scale of Alcohol-Revised (CIWA-Ar. Post-withdrawal phase, quality of life of patients was assessed at end of 01 st , 03 rd and 06 th month using World Health Organisation quality of life (WHOQOL- BREF. Results and Analysis: There was a significant decrease in CIWA-Ar mean scores and increase in quality of life score (P < 0.001. The most common remedies used were Arsenicum album, Lycopodium clavatum, Belladonna, Nux vomica and Pulsatilla. Conclusion: The results of current observational pilot study suggest the promising use of Homoeopathy in the management of acute alcohol withdrawal. Further studies with large sample size and rigorous design are warranted.

  2. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study.

    Science.gov (United States)

    Boselli, E; Bouvet, L; Bégou, G; Dabouz, R; Davidson, J; Deloste, J-Y; Rahali, N; Zadam, A; Allaouchiche, B

    2014-04-01

    The analgesia/nociception index (ANI) is derived from heart rate variability, ranging from 0 (maximal nociception) to 100 (maximal analgesia), to reflect the analgesia/nociception balance during general anaesthesia. This should be correlated with immediate postoperative pain in the post-anaesthesia care unit (PACU). The aim of this study was to evaluate the performance of ANI measured at arousal from general anaesthesia to predict immediate postoperative pain on arrival in PACU. Two hundred patients undergoing ear, nose, and throat or lower limb orthopaedic surgery with general anaesthesia using an inhalational agent and remifentanil were included in this prospective observational study. The ANI was measured immediately before tracheal extubation and pain intensity was assessed within 10 min of arrival in PACU using a 0-10 numerical rating scale (NRS). The relationship between ANI and NRS was assessed using linear regression. A receiver-operating characteristic (ROC) curve was used to evaluate the performance of ANI to predict NRS>3. A negative linear relationship was observed between ANI immediately before extubation and NRS on arrival in PACU. Using a threshold of 3 were both 86% with 92% negative predictive value, corresponding to an area under the ROC curve of 0.89. The measurement of ANI immediately before extubation after inhalation-remifentanil anaesthesia was significantly associated with pain intensity on arrival in PACU. The performance of ANI for the prediction of immediate postoperative pain is good and may assist physicians in optimizing acute pain management. ClinicalTrials.gov NCT01796249.

  3. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  4. Evaluation of homoeopathic medicines as add-on to institutional management protocol in Acute Encephalitis Syndrome: An exploratory observational comparative study

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2015-01-01

    Conclusion: This exploratory observational study suggests reduction of mortality and morbidity with add-on homoeopathic medicine. Further randomized controlled trial study with comparable groups is desirable. If findings are confirmed by subsequent research, add-on Homoeopathy might have relevant implication for its management.

  5. Intake of total protein, plant protein and animal protein in relation to blood pressure : a meta-analysis of observational and intervention studies

    NARCIS (Netherlands)

    Tielemans, S. M. A. J.; Altorf-van der Kuil, W.; Engberink, M. F.; Brink, E. J.; van Baak, M. A.; Bakker, S. J. L.; Geleijnse, J. M.

    There is growing evidence from epidemiological studies that dietary protein may beneficially influence blood pressure (BP), but findings are inconclusive. We performed a meta-analysis of 29 observational studies and randomized controlled trials (RCTs) of dietary protein and types of protein in

  6. What are the health benefits of active travel? A systematic review of trials and cohort studies.

    Directory of Open Access Journals (Sweden)

    Lucinda E Saunders

    Full Text Available BACKGROUND: Increasing active travel (primarily walking and cycling has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. METHODS: The study design was a systematic review of (i non-randomised and randomised controlled trials, and (ii prospective observational studies examining either (a the effects of interventions to promote active travel or (b the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. RESULTS: Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. CONCLUSIONS: Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such

  7. Observational Study Designs for Comparative Effectiveness Research: An Alternative Approach to Close Evidence Gaps in Head-and-Neck Cancer

    International Nuclear Information System (INIS)

    Goulart, Bernardo H.L.; Ramsey, Scott D.; Parvathaneni, Upendra

    2014-01-01

    Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H and N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H and N RCTs, which limits the validity of their results to the broader H and N cancer patient population seen in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H and N cancer, including treatment comparisons for rare types of H and N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H and N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H and N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design

  8. Association between day of delivery and obstetric outcomes: observational study.

    Science.gov (United States)

    Palmer, William L; Bottle, A; Aylin, P

    2015-11-24

    What is the association between day of delivery and measures of quality and safety of maternity services, particularly comparing weekend with weekday performance? This observational study examined outcomes for maternal and neonatal records (1,332,835 deliveries and 1,349,599 births between 1 April 2010 and 31 March 2012) within the nationwide administrative dataset for English National Health Service hospitals by day of the week. Groups were defined by day of admission (for maternal indicators) or delivery (for neonatal indicators) rather than by day of complication. Logistic regression was used to adjust for case mix factors including gestational age, birth weight, and maternal age. Staffing factors were also investigated using multilevel models to evaluate the association between outcomes and level of consultant presence. The primary outcomes were perinatal mortality and-for both neonate and mother-infections, emergency readmissions, and injuries. Performance across four of the seven measures was significantly worse for women admitted, and babies born, at weekends. In particular, the perinatal mortality rate was 7.3 per 1000 babies delivered at weekends, 0.9 per 1000 higher than for weekdays (adjusted odds ratio 1.07, 95% confidence interval 1.02 to 1.13). No consistent association between outcomes and staffing was identified, although trusts that complied with recommended levels of consultant presence had a perineal tear rate of 3.0% compared with 3.3% for non-compliant services (adjusted odds ratio 1.21, 1.00 to 1.45). Limitations of the analysis include the method of categorising performance temporally, which was mitigated by using a midweek reference day (Tuesday). Further research is needed to investigate possible bias from unmeasured confounders and explore the nature of the causal relationship. This study provides an evaluation of the "weekend effect" in obstetric care, covering a range of outcomes. The results would suggest approximately