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Sample records for trial observational study

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

    Science.gov (United States)

    Malmivaara, Antti

    2016-09-01

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

  2. 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

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

    Science.gov (United States)

    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

  4. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins

    NARCIS (Netherlands)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J.

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions).

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

    Science.gov (United States)

    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.

  6. Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

    Science.gov (United States)

    Malmivaara, Antti

    2015-06-01

    The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

  7. Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

    Science.gov (United States)

    Malmivaara, Antti

    2016-01-01

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

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

    Science.gov (United States)

    Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

    2014-04-01

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

  9. Expanding the Evidence Base: Comparing Randomized Controlled Trials and Observational Studies of Statins.

    Science.gov (United States)

    Atar, Dan; Ong, Seleen; Lansberg, Peter J

    2015-01-01

    It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions). To examine the role that observational studies can play in complementing data from RCTs, we reviewed published studies for statins, a class of drugs that have been widely used to reduce the risk of cardiovascular (CV) events by lowering low-density lipoprotein cholesterol levels. RCTs have consistently demonstrated the benefits of statin treatment in terms of CV risk reduction and have demonstrated that more intensive statin therapy has incremental benefits over less intensive treatment. Observational studies of statin use in 'real-world' populations have served to augment the evidence base generated from statin RCTs in preselected populations of patients who are often at high CV risk and have led to similar safety and efficacy findings. They have also raised questions about factors affecting medication adherence, under-treatment, switching between statins, and failure to reach low-density lipoprotein cholesterol target levels, questions for which the answers could lead to improved patient care.

  10. A Radical Sodium Reduction Policy is not Supported by Randomized Controlled Trials or Observational Studies

    DEFF Research Database (Denmark)

    Graudal, Niels

    2016-01-01

    Several health institutions recommend sodium intake be reduced to below 2,300 mg, which means that 6-7 billion individuals should alter their diet to accommodate. Such a radical recommendation should be based on solid evidence. However, this review reveals that (i) there are no randomized...... controlled trials (RCTs) allocating individuals to below 2,300 mg and measuring health outcomes; (ii) RCTs allocating risk groups such as obese prehypertensive individuals and hypertensive individuals down to (but not below) 2,300 mg show no effect of sodium reduction on all-cause mortality; (iii) RCTs...... allocating individuals to below 2,300 mg show a minimal effect on blood pressure in the healthy population (less than 1mm Hg) and significant increases in renin, aldosterone, noradrenalin cholesterol, and triglyceride; and (iv) observational studies show that sodium intakes below 2,645 and above 4,945 mg...

  11. Informing potential participants about research: observational study with an embedded randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Helen M Kirkby

    Full Text Available OBJECTIVES: To assess: 1 the feasibility of electronic information provision; 2 gather evidence on the topics and level of detail of information potential research participant's accessed; 3 to assess satisfaction and understanding. DESIGN: Observational study with an embedded randomised controlled trial. SETTING: Low risk intervention study based in primary care. PARTICIPANTS: White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study. INTERVENTIONS: PDF copy of the standard paper participant information sheet (PDF-PIS and an electronic Interactive Information Sheet (IIS where participants could choose both the type and level of detail accessed. MAIN OUTCOME MEASURES: 1 Proportion of participants providing an email address and accessing electronic information 2 Willingness to participate in a recruitment clinic. 3 Type and depth of information accessed on the IIS. 4 Participant satisfaction and understanding. RESULTS: 1160 participants were eligible for the study. Of these, 276 (24% provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4. Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59% who chose not to access any electronic information also booked an appointment. CONCLUSIONS: Current written information about research may not be read, emphasising the importance of the consent

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

    Science.gov (United States)

    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.

  13. What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial.

    Science.gov (United States)

    Sharma, Anjana E; Willard-Grace, Rachel; Hessler, Danielle; Bodenheimer, Thomas; Thom, David H

    2016-05-01

    Health coaching is effective for chronic disease self-management in the primary care safety-net setting, but little is known about the persistence of its benefits. We conducted an observational study evaluating the maintenance of improved cardiovascular risk factors following a health coaching intervention. We performed a naturalistic follow-up to the Health Coaching in Primary Care Study, a 12-month randomized controlled trial (RCT) comparing health coaching to usual care for patients with uncontrolled diabetes, hypertension, or hyperlipidemia. Participants were followed up 24 months from RCT baseline. The primary outcome was the proportion at goal for at least 1 measure (hemoglobin A1c, systolic blood pressure, or LDL cholesterol) that had been above goal at enrollment; secondary outcomes included each individual clinical goal. Chi-square tests and paired t-tests compared dichotomous and continuous measures. 290 of 441 participants (65.8%) participated at both 12 and 24 months. The proportion of patients in the coaching arm of the RCT who achieved the primary outcome dropped only slightly from 47.1% at 12 to 45.9% at 24 months (P = .80). The proportion at goal for hemoglobin A1c dropped from 53.4% to 36.2% (P = .03). All other clinical metrics had small, nonsignificant changes between 12 and 24 months. Results support the conclusion that most improved clinical outcomes persisted 1 year after the completion of the health coaching intervention. © 2016 Annals of Family Medicine, Inc.

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

    Science.gov (United States)

    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.

  15. Comparison between treatment effects in a randomised controlled trial and an observational study using propensity scores in primary care

    NARCIS (Netherlands)

    Stuart, Beth L.; Grebel, Louise E.N.; Butler, Christopher C.; Hood, Kerenza; Verheij, Theo J.M.; Little, Paul

    2017-01-01

    Background  Although randomised controlled trials (RCTs) are considered 'gold standard' evidence, they are not always feasible or appropriate, and may represent a select population. Observational studies provide a useful alternative to enhance applicability, but results can be biased due to

  16. 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

  17. YouTube Videos as a Source of Information About Clinical Trials: Observational Study.

    Science.gov (United States)

    Hillyer, Grace Clarke; MacLean, Sarah A; Beauchemin, Melissa; Basch, Corey H; Schmitt, Karen M; Segall, Leslie; Kelsen, Moshe; Brogan, Frances L; Schwartz, Gary K

    2018-06-26

    Clinical trials are essential to the advancement of cancer treatment but fewer than 5% of adult cancer patients enroll in a trial. A commonly cited barrier to participation is the lack of understanding about clinical trials. Since the internet is a popular source of health-related information and YouTube is the second most visited website in the world, we examined the content of the top 115 YouTube videos about clinical trials to evaluate clinical trial information available through this medium. YouTube videos posted prior to March 2017 were searched using selected keywords. A snowballing technique was used to identify videos wherein sequential screening of the autofill search results for each set of keywords was conducted. Video characteristics (eg, number of views and video length) were recorded. The content was broadly grouped as related to purpose, phases, design, safety and ethics, and participant considerations. Stepwise multivariable logistic regression analysis was conducted to assess associations between video type (cancer vs noncancer) and video characteristics and content. In total, 115 videos were reviewed. Of these, 46/115 (40.0%) were cancer clinical trials videos and 69/115 (60.0%) were noncancer/general clinical trial videos. Most videos were created by health care organizations/cancer centers (34/115, 29.6%), were oriented toward patients (67/115, 58.3%) and the general public (68/115, 59.1%), and were informational (79/115, 68.7%); altruism was a common theme (31/115, 27.0%). Compared with noncancer videos, cancer clinical trials videos more frequently used an affective communication style and mentioned the benefits of participation. Cancer clinical trial videos were also much more likely to raise the issue of costs associated with participation (odds ratio [OR] 5.93, 95% CI 1.15-29.46) and advise patients to communicate with their physician about cancer clinical trials (OR 4.94, 95% CI 1.39-17.56). Collectively, YouTube clinical trial videos

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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

  3. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

    Science.gov (United States)

    Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

    2010-10-01

    In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

  4. Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies Proposal of a Multidisciplinary Research Group

    NARCIS (Netherlands)

    Vergouwen, Mervyn D. I.; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J. E.; Wijdicks, Eelco F.; Muizelaar, J. Paul; Mendelow, A. David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G.; Macdonald, R. Loch; Diringer, Michael N.; Broderick, Joseph P.; Dreier, Jens P.; Roos, Yvo B. W. E. M.

    2010-01-01

    Background and Purpose-In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence 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.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available 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

  6. Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials.

    Science.gov (United States)

    Mathes, Tim; Buehn, Stefanie; Prengel, Peggy; Pieper, Dawid

    2018-01-01

    The objective of this study was to analyze the features of registry-based randomized trials (rRCTs). We systematically searched PubMed for rRCTs. Study selection was performed independently by two reviewers. We extracted all data in standardized tables and prepared descriptive summary statistics. The search resulted in 1,202 hits. We included 71 rRCTs. Most rRCTs were from Denmark and Sweden. Chronic conditions were considered in 82.2%. A preventive intervention was examined in 45.1%. The median of included patients was 2,000 (range: 69-246,079). Definition of the study population was mostly broad. Study procedures were regularly little standardized. The number of included and analyzed patients was the same in 82.1%. In half of the rRCTs, more than one registry was utilized. Various linkage techniques were used. In median, two outcomes were collected from the registry/ies. The median follow-up of the rRCTs was 5.3 years (range: 6 weeks to 27 years). Information on quality of registry data was reported in 11.3%. rRCTs can provide valid (randomization, low lost-to-follow-up rates, generalizable) patient important long-term comparative-effectiveness data for relative little effort. Researchers planning an RCT should always check whether existing registries can be used for data collection. Reporting on data quality must be improved for use in evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Conflicting results between randomized trials and observational studies on the impact of proton pump inhibitors on cardiovascular events when coadministered with dual antiplatelet therapy: systematic review.

    Science.gov (United States)

    Melloni, Chiara; Washam, Jeffrey B; Jones, W Schuyler; Halim, Sharif A; Hasselblad, Victor; Mayer, Stephanie B; Heidenfelder, Brooke L; Dolor, Rowena J

    2015-01-01

    Discordant results have been reported on the effects of concomitant use of proton pump inhibitors (PPIs) and dual antiplatelet therapy (DAPT) for cardiovascular outcomes. We conducted a systematic review comparing the effectiveness and safety of concomitant use of PPIs and DAPT in the postdischarge treatment of unstable angina/non-ST-segment-elevation myocardial infarction patients. We searched for clinical studies in MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews, from 1995 to 2012. Reviewers screened and extracted data, assessed applicability and quality, and graded the strength of evidence. We performed meta-analyses of direct comparisons when outcomes and follow-up periods were comparable. Thirty-five studies were eligible. Five (4 randomized controlled trials and 1 observational) assessed the effect of omeprazole when added to DAPT; the other 30 (observational) assessed the effect of PPIs as a class when compared with no PPIs. Random-effects meta-analyses of the studies assessing PPIs as a class consistently reported higher event rates in patients receiving PPIs for various clinical outcomes at 1 year (composite ischemic end points, all-cause mortality, nonfatal MI, stroke, revascularization, and stent thrombosis). However, the results from randomized controlled trials evaluating omeprazole compared with placebo showed no difference in ischemic outcomes, despite a reduction in upper gastrointestinal bleeding with omeprazole. Large, well-conducted observational studies of PPIs and randomized controlled trials of omeprazole seem to provide conflicting results for the effect of PPIs on cardiovascular outcomes when coadministered with DAPT. Prospective trials that directly compare pharmacodynamic parameters and clinical events among specific PPI agents in patients with unstable angina/non-ST-segment-elevation myocardial infarction treated with DAPT are warranted. © 2015 American Heart Association, Inc.

  8. 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

    Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. 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. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

  9. 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

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

    Science.gov (United States)

    Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

    2017-09-01

    Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). 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.

  11. The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J; Brawer, Michael K; Barry, Michael J; Jones, Karen M; Kwon, Young; Gingrich, Jeffrey R; Aronson, William J; Nsouli, Imad; Iyer, Padmini; Cartagena, Ruben; Snider, Glenn; Roehrborn, Claus; Fox, Steven

    2009-01-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia. We screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason

  12. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  13. 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

  14. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    Science.gov (United States)

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  15. Comparison of treatment effect estimates of non-vitamin K antagonist oral anticoagulants versus warfarin between observational studies using propensity score methods and randomized controlled trials

    International Nuclear Information System (INIS)

    Li, Guowei; Holbrook, Anne; Jin, Yanling; Zhang, Yonghong; Levine, Mitchell A. H.; Mbuagbaw, Lawrence; Witt, Daniel M.; Crowther, Mark; Connolly, Stuart; Chai-Adisaksopha, Chatree; Wan, Zhongxiao; Cheng, Ji; Thabane, Lehana

    2016-01-01

    Emerging observational studies using propensity score (PS) methods assessed real-world comparative effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin in patients with non-valvular atrial fibrillation (AF). We aimed to compare treatment effect estimates of NOACs between PS studies and randomized controlled trials (RCTs). Electronic databases and conference proceedings were searched systematically. Primary outcomes included stroke or systemic embolism (SE) and major bleeding. A random-effects meta-analysis was performed to synthesize the data by pooling the PS- and RCT-derived hazard ratios (HRs) separately. The ratio of HRs (RHR) from the ratio of PS-derived HRs relative to RCT-derived HRs was used to determine whether there was a difference between estimates from PS studies and RCTs. There were 10 PS studies and 5 RCTs included for analysis. No significant difference of treatment effect estimates between the PS studies and RCTs was observed: RHR 1.11, 95 % CI 0.98–1.23 for stroke or SE; RHR 1.07, 95 % CI 0.87–1.34 for major bleeding. A significant association between NOACs and risk of stroke or SE was observed: HR 0.88, 95 % CI 0.83–0.94 for the PS studies; HR 0.79, 95 % CI 0.72–0.87 for the RCTs. However, no relationship between NOACs and risk of major bleeding was found: HR 0.91, 95 % CI 0.79–1.05 for the PS studies; HR 0.85, 95 % CI 0.73–1.00 for the RCTs. In this study, treatment effect estimates of NOACs versus warfarin in patients with non-valvular AF from PS studies are found to be in agreement with those from RCTs.

  16. 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.

  17. 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.

  18. 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.

  19. The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease.

    Science.gov (United States)

    van der Linden, Michelle; Meeuwis, Kim; van Hees, Colette; van Dorst, Eleonora; Bulten, Johan; Bosse, Tjalling; IntHout, Joanna; Boll, Dorry; Slangen, Brigitte; van Seters, Manon; van Beurden, Marc; van Poelgeest, Mariëtte; de Hullu, Joanne

    2017-09-06

    Vulvar Paget disease is a rare skin disorder, which is most common in postmenopausal Caucasian women. They usually present with an erythematous plaque that may show fine or typical "cake icing" scaling or ulceration that may cause itching, pain, irritation, or a burning sensation. Although most cases are noninvasive, vulvar Paget disease may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The histological evidence of so-called "Paget cells" with abundant pale cytoplasm in the epithelium confirms the diagnosis. The origin of these Paget cells is still unclear. Treatment of choice is wide local excision with negative margins. Obtaining clear surgical margins is challenging and may lead to extensive and mutilating surgery. Even then, recurrence rates are high, ranging from 15% to 70%, which emphasizes the need for new treatment options. A number of case reports, retrospective case series, and one observational study have shown promising results using the topical immune response modifier imiquimod. This study aims to investigate the efficacy, safety, and immunological response in patients with noninvasive vulvar Paget disease using a standardized treatment schedule with 5% imiquimod cream. Topical 5% imiquimod cream might be an effective and safe treatment alternative for vulvar Paget disease. The Paget Trial is a multicenter observational cohort study including eight tertiary referral hospitals in the Netherlands. It is ethically approved by the Medical-Ethical Committee of Arnhem-Nijmegen and registered in the Central Committee on Research Involving Human Subjects (CCMO) Register by as NL51648.091.14. Twenty patients with (recurrent) noninvasive vulvar Paget disease will be treated with topical 5% imiquimod cream three times a week for 16 weeks. The primary efficacy outcome is the reduction in lesion size at 12 weeks after end of treatment. Secondary outcomes are safety, immunological response, and quality of life. Safety will be

  20. Assessing the association between natural food folate intake and blood folate concentrations: a systematic review and Bayesian meta-analysis of trials and observational studies.

    Science.gov (United States)

    Marchetta, Claire M; Devine, Owen J; Crider, Krista S; Tsang, Becky L; Cordero, Amy M; Qi, Yan Ping; Guo, Jing; Berry, Robert J; Rosenthal, Jorge; Mulinare, Joseph; Mersereau, Patricia; Hamner, Heather C

    2015-04-10

    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.

  1. 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.

  2. Effect of early supplemental parenteral nutrition in the paediatric ICU: a preplanned observational study of post-randomisation treatments in the PEPaNIC trial.

    Science.gov (United States)

    Vanhorebeek, Ilse; Verbruggen, Sascha; Casaer, Michaël P; Gunst, Jan; Wouters, Pieter J; Hanot, Jan; Guerra, Gonzalo Garcia; Vlasselaers, Dirk; Joosten, Koen; Van den Berghe, Greet

    2017-06-01

    Large randomised controlled trials have shown that early supplemental parenteral nutrition in patients admitted to adult and paediatric intensive care units (PICUs) is harmful. Overdosing of energy with too little protein was suggested as a potential reason for this. This study analysed which macronutrient was associated with harm caused by early supplemental parenteral nutrition in the Paediatric Early versus Late Parenteral Nutrition In Critical Illness (PEPaNIC) randomised trial. Patients in the initial randomised controlled trial were randomly assigned to receive suppplemental parenteral nutrition (PN) within 24 h of PICU admission (early PN) or to receive such PN after 1 week (late PN) when enteral nutrition was insufficient. In this post-randomisation, observational study, doses of glucose, lipids, and aminoacids administered during the first 7 days of PICU stay were expressed as % of reference doses from published clinical guidelines for age and weight. Independent associations between average macronutrient doses up to each of the first 7 days and likelihood of acquiring an infection in the PICU, of earlier live weaning from mechanical ventilation, and of earlier live PICU discharge were investigated using multivariable Cox proportional hazard analyses. The three macronutrients were included in the analysis simultaneously and baseline risk factors were adjusted for. From June 18, 2012, to July 27, 2015, 7519 children aged between newborn and 17 years were assessed for eligibility. 6079 patients were excluded, and 1440 children were randomly assigned to receive either early PN (n=723) or late PN (n=717). With increasing doses of aminoacids, the likelihood of acquiring a new infection was higher (adjusted hazard ratios [HRs] per 10% increase between 1·043-1·134 for days 1-5, p≤0·029), while the likelihood of earlier live weaning from mechanical ventilation was lower (HRs 0·950-0·975 days 3-7, p≤0·045), and the likelihood of earlier live PICU

  3. 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 (Pflexibility, 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 Elsevier Inc. All rights reserved.

  4. A Prospective Observational Study

    African Journals Online (AJOL)

    Methods: This was a prospective, questionnaire-based observational study. Printed questionnaires were distributed to the visitors of medical, surgical and neurosurgical ICU patients to determine awareness of basic infection control practices among visitors to an ICU. All the ICU staff, including nurses, doctors, consultant ...

  5. 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.

  6. 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

  7. An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial

    Directory of Open Access Journals (Sweden)

    Nixon DR

    2012-12-01

    Full Text Available Donald R Nixon,1 Susan Simonyi,2 Meetu Bhogal,2 Christopher S Sigouin,3 Andrew C Crichton,4 Marino Discepola,5 Cindy ML Hutnik,6 David B Yan71Private Practice, Barrie, ON, 2Allergan Inc, Markham, ON, 3CLINWest Research, Burlington, ON, 4University of Calgary, Calgary, AB, 5McGill University, Montreal, QC, 6London Health Sciences Centre, London, ON, 7University of Toronto, Toronto, ON, CanadaBackground: This study was designed to evaluate the occurrence and severity of ocular hyperemia in subjects with elevated intraocular pressure (IOP due to primary open angle glaucoma (POAG or ocular hypertension (OHT following treatment with bimatoprost 0.01% in a real-world clinical setting.Methods: This was an open-label, observational study conducted at 67 centers in Canada. Subjects with elevated IOP due to POAG or OHT instilled bimatoprost 0.01% topically as monotherapy once daily. Ocular hyperemia was graded by the investigator at baseline and weeks 6 and 12 using a photographic five-point grading scale. Change in IOP from baseline was also evaluated at these time points. This analysis includes only the subgroup of 522 subjects who were naïve to IOP-lowering medication prior to the study.Results: After 12 weeks of treatment with bimatoprost 0.01%, hyperemia was graded as none-to-mild (grades 0, +0.5, or +1 for 93.3% of subjects and as moderate-to-severe (grades +2 or +3 for 6.7%. At weeks 6 and 12, most subjects (93.2% and 93.5% had no change in hyperemia grade from baseline. IOP was reduced by 7.4 mmHg (29.8% at week 6 and 7.7 mmHg (30.9% at week 12 from baseline.Conclusion: This real-world, observational study found that bimatoprost 0.01% instilled once daily reduced IOP by a mean of 30% from baseline without moderate or severe ocular hyperemia in 93% of treatment-naïve subjects with POAG or OHT.Keywords: glaucoma, intraocular pressure, hyperemia, bimatoprost

  8. 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.

  9. An observational study of bimatoprost 0.01% in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan® RC Early Analysis Review (CLEAR trial

    Directory of Open Access Journals (Sweden)

    Crichton AC

    2014-05-01

    Full Text Available Andrew C Crichton,1 Donald R Nixon,2 Susan Simonyi,3 Meetu Bhogal,3 Christopher S Sigouin,4 Marino J Discepola,5 Cindy ML Hutnik,6 Darryl C Baptiste,3 David B Yan7 On behalf of the CLEAR Study Group 1Division of Ophthalmology, University of Calgary, Calgary, AB, Canada; 2Private practice, Barrie, ON, Canada; 3Medical Affairs, Allergan Inc., Markham, ON, Canada; 4CLINWest Research, Burlington, ON, Canada; 5Department of Ophthalmology, McGill University, Montreal, QC, Canada; 6Department of Ophthalmology and Pathology, Ivey Eye Institute, London, ON, Canada; 7Department of Ophthalmology, University of Toronto, Toronto, ON, Canada Purpose: To evaluate the ocular hyperemia and intraocular pressure (IOP-lowering efficacy of bimatoprost 0.01% in subjects with elevated IOP due to primary open-angle glaucoma (POAG or ocular hypertension (OHT in a real-world clinical setting. Subjects and methods: This open-label, 12-week, observational study was conducted at 67 centers in Canada. Subjects with elevated IOP due to POAG or OHT instilled bimatoprost 0.01% as monotherapy once daily. Ocular hyperemia was graded by the investigator at baseline, week 6, and week 12 using a standardized photographic 5-point grading scale. Change in IOP from baseline was also evaluated at these time points. This analysis includes the subgroup of 268 subjects who had been previously treated with latanoprost 0.005%, bimatoprost 0.03%, travoprost 0.004%, and travoprost 0.004% with SofZia™ or nonselective beta-adrenergic receptor blockers prior to the study. Results: After 12 weeks of treatment with 0.01% bimatoprost, ocular hyperemia was graded as none-to-mild hyperemia (grades 0, +0.5, or +1 for 94.1% of subjects and as moderate-to-severe hyperemia (grades +2 or +3 for 5.9%. No statistically significant shifts in ocular hyperemia ratings were observed at week 12 for any of the prior IOP-lowering therapies except bimatoprost 0.03%, in which 20.8% of subjects experienced an

  10. 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...... randomised to BCG at birth and examined for scar at 12 months; a subgroup was tested for PPD response at 2 and 6 months. The BCG batches from the Slow growth period were compared with the precedent and subsequent Normal growth batches with regard to prevalence and size of BCG scar and PPD response. We also...... batches were associated with larger scar size (5.0mm) than precedent (4.4mm, pPPD responses, and among PPD positive children, a larger PPD...

  11. 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.

  12. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

    Science.gov (United States)

    Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

    2016-04-01

    Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  13. 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

  14. Impact of Short- and Long-term Tai Chi Mind-Body Exercise Training on Cognitive Function in Healthy Adults: Results From a Hybrid Observational Study and Randomized Trial.

    Science.gov (United States)

    Walsh, Jacquelyn N; Manor, Brad; Hausdorff, Jeffrey; Novak, Vera; Lipsitz, Lewis; Gow, Brian; Macklin, Eric A; Peng, Chung-Kang; Wayne, Peter M

    2015-07-01

    Cognitive decline amongst older adults is a significant public health concern. There is growing interest in behavioral interventions, including exercise, for improving cognition. Studies to date suggest tai chi (TC) may be a safe and potentially effective exercise for preserving cognitive function with aging; however, its short-term and potential long-term impact on physically active, healthy adults is unclear. To compare differences in cognitive function among long-term TC expert practitioners and age-matched and gender-matched TC-naïve adults and to determine the effects of short-term TC training on measures of cognitive function in healthy, nonsedentary adults. A hybrid design including an observational comparison and a 2-arm randomized clinical trial (RCT). Healthy, nonsedentary, TC-naive adults (50 y-79 y) and age-matched and gender-matched long-term TC experts. A cross-sectional comparison of cognitive function in healthy TC-naïve (n=60) and TC expert (24.5 y ÷ 12 y experience; n=27) adults: TC-naïve adults then completed a 6-month, 2-arm, wait-list randomized clinical trial of TC training. Six measures of cognitive function were assessed for both cross-sectional and longitudinal comparisons. TC experts exhibited trends towards better scores on all cognitive measures, significantly so for category fluency (P=.01), as well as a composite z score summarizing all 6 cognitive assessments (P=.03). In contrast, random assignment to 6 months of TC training in TC-naïve adults did not significantly improve any measures of cognitive function. In healthy nonsedentary adults, long-term TC training may help preserve cognitive function; however, the effect of short-term TC training in healthy adults remains unclear. ClinicalTrials.gov NCT01340365.

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

    OpenAIRE

    Marchetta, Claire M.; Devine, Owen J.; Crider, Krista S.; Tsang, Becky L.; Cordero, Amy M.; Qi, Yan Ping; Guo, Jing; Berry, Robert J.; Rosenthal, Jorge; Mulinare, Joseph; Mersereau, Patricia; Hamner, Heather C.

    2015-01-01

    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 folat...

  16. 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.

  17. 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

  18. Distracted Biking: An Observational Study.

    Science.gov (United States)

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

    2016-01-01

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

  19. The effects of video observation of chewing during lunch on masticatory ability, food intake, cognition, activities of daily living, depression, and quality of life in older adults with dementia: a study protocol of an adjusted randomized controlled trial.

    Science.gov (United States)

    Douma, Johanna G; Volkers, Karin M; Vuijk, Pieter Jelle; Scherder, Erik J A

    2016-02-04

    Masticatory functioning alters with age. However, mastication has been found to be related to, for example, cognitive functioning, food intake, and some aspects of activities of daily living. Since cognitive functioning and activities of daily living show a decline in older adults with dementia, improving masticatory functioning may be of relevance to them. A possible way to improve mastication may be showing videos of people who are chewing. Observing chewing movements may activate the mirror neuron system, which becomes also activated during the execution of that same movement. The primary hypothesis is that the observation of chewing has a beneficial effect on masticatory functioning, or, more specifically, masticatory ability of older adults with dementia. Secondary, the intervention is hypothesized to have beneficial effects on food intake, cognition, activities of daily living, depression, and quality of life. An adjusted parallel randomized controlled trial is being performed in dining rooms of residential care settings. Older adults with dementia, for whom also additional eligibility criteria apply, are randomly assigned to the experimental (videos of chewing people) or control condition (videos of nature and buildings), by drawing folded pieces of paper. Participants who are able to watch each other's videos are assigned to the same study condition. The intervention takes place during lunchtime, from Monday to Friday, for 3 months. During four moments of measurement, masticatory ability, food intake, cognitive functioning, activities of daily living, depression, and quality of life are assessed. Tests administrators blind to the group allocation administer the tests to participants. The goal of this study is to examine the effects of video observation of chewing on masticatory ability and several secondary outcome measures. In this study, the observation of chewing is added to the execution of the same action (i.e., during eating). Beneficial effects on

  20. Does a balanced transfusion ratio of plasma to packed red blood cells improve outcomes in both trauma and surgical patients? A meta-analysis of randomized controlled trials and observational studies.

    Science.gov (United States)

    Rahouma, Mohamed; Kamel, Mohamed; Jodeh, Diana; Kelley, Thomas; Ohmes, Lucas B; de Biasi, Andreas R; Abouarab, Ahmed A; Benedetto, Umberto; Guy, T Sloane; Lau, Christopher; Lee, Paul C; Girardi, Leonard N; Gaudino, Mario

    2017-09-23

    The effect of high transfusion ratios of fresh frozen plasma (FFP): packed red blood cell (RBC) on mortality is still controversial. Observational evidence contradicts a recent randomized controlled trial regarding mortality benefit. This is an updated meta-analysis, including a non-trauma cohort. Patients were grouped into high vs. low based on FFP:RBC ratio. Primary outcomes were 24-h and 30-day/in-hospital mortality. Secondary outcomes were acute respiratory distress syndrome and acute lung injury rates. Random model and leave-one-out-analyses were used. In 36 studies, lower ratio showed poorer 24-h and 30-day survival (p ratio was associated with worse 24-h and 30-day mortality (P ratio of 1:1.5 provided the largest 24-h and 30-day survival benefit (p ratio was not associated with ARDS or ALI. High FFP:RBC ratio confers survival benefits in trauma and non-trauma settings, with the highest survival benefit at 1:1.5. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background 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. Methods 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. Results 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. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  2. 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.

  3. Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Jasmin Stadler

    2018-01-01

    Full Text Available Background. Nonpharmacological strategies have actually become more important in neonatal pain management during routinely applied minor painful procedures. However, commonly used nonpharmacological strategies are inferior to orally administered sweet solutions. Therefore, we will compare laser acupuncture, as a recent nonpharmacological method, with the standard care of oral glucose solution for pain prevention. Methods. Ninety-five healthy term neonates will be allocated into one of two groups. Before routine heel lance for metabolic screening, one group will receive laser acupuncture at acupuncture point Large Intestine 4 (LI 4 bilaterally for 60 seconds per point (acupuncture group and the other will receive the standard care with orally administered glucose solution (glucose group. The complete procedure of blood sampling will be recorded on video, excluding the intervention before heel lance. A paediatric nurse, blinded with respect to the allocation, will evaluate these video recordings and determine the Premature Infant Pain Profile (PIPP for each neonate. Primary outcome will be the mean difference in PIPP scores between groups. Discussion. This observer-blinded randomised controlled trial has been designed to explore potential advantages of laser acupuncture in the management of neonatal pain because more data are required to provide information about its efficacy and safety. Trial Registration. This trial is registered with DRKS00010122.

  4. 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 observ......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...

  5. 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.

  6. 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

  7. Science Studies from Archived Observations

    Science.gov (United States)

    Armstrong, T. P.; Manweiler, J. W.; Patterson, J. D.

    2008-12-01

    Goals for spaceflight investigations include the discovery and characterization of physical features of the in- situ and remote environment. Abundant successes of flight investigations are easily documented. Prudent scientific practice dictates that to the maximum extent possible, observations should be well-characterized, reliably catalogued, and knowledgeably interpreted. This is especially true of data sets used in the publication of results in the reviewed literature. Typical scientific standards include making primary data numbers available to other investigators for replicated study. While NASA's contracts with investigators have required that data be submitted to agency official archives, the details, completeness (especially of ancillary and metadata) and forms differ from investigation to investigation and project to project. After several generations of improvements and refinements, modern computing and communications technology makes it possible to link multiple data sets at multiple locations through a unified data model. Virtual Observatories provide the overall organizational structures and SPASE-compliant XML defines the data granules that can be located. Proofs of the feasibility and value of this latest approach remain to be seen, but its ultimate goal of improving archival research using flight-derived data sets appears to depend on user acceptance and efficient use of the VxO resources. Criteria based on the authors experience in science derived from archival sources follow: 1. Interfaces and tools must be easy to learn, easy to use, and reliable. 2. Data numbers must be promptly downloadable in plain text. 3. Data must be available in or readily converted to physical units using calibrations and algorithms easily traceable as part of the search. Knowledge about (or heritage of) specific data items present in the science literature must be associated with the search for that item. 4. Data items must be trustworthy, having quoted uncertainties and

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

    NARCIS (Netherlands)

    Pagnoux, C.; Carette, S.; Khalidi, N. A.; Walsh, M.; Hiemstra, T. F.; Cuthbertson, D.; Langford, C.; Hoffman, G.; Koening, C. L.; Monach, P. A.; Moreland, L.; Mouthon, L.; Seo, P.; Specks, U.; Ytterbere, S.; Westman, K.; Hoglund, P.; Harper, L.; Flossmann, O.; Luqmani, R.; Savage, C.; Rasmussen, N.; de Groot, K.; Tesar, V.; Jayne, D.; Merkel, P. A.; Guillevin, L.; Stegeman, C. A.

    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

  9. Marketing and clinical trials: a case study

    OpenAIRE

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

    2007-01-01

    Abstract Background 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. Methods 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, o...

  10. Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial.

    Science.gov (United States)

    Stadler, Jasmin; Avian, Alexander; Posch, Katrin; Urlesberger, Berndt; Raith, Wolfgang

    2018-01-01

    Nonpharmacological strategies have actually become more important in neonatal pain management during routinely applied minor painful procedures. However, commonly used nonpharmacological strategies are inferior to orally administered sweet solutions. Therefore, we will compare laser acupuncture, as a recent nonpharmacological method, with the standard care of oral glucose solution for pain prevention. Ninety-five healthy term neonates will be allocated into one of two groups. Before routine heel lance for metabolic screening, one group will receive laser acupuncture at acupuncture point Large Intestine 4 (LI 4) bilaterally for 60 seconds per point (acupuncture group) and the other will receive the standard care with orally administered glucose solution (glucose group). The complete procedure of blood sampling will be recorded on video, excluding the intervention before heel lance. A paediatric nurse, blinded with respect to the allocation, will evaluate these video recordings and determine the Premature Infant Pain Profile (PIPP) for each neonate. Primary outcome will be the mean difference in PIPP scores between groups. This observer-blinded randomised controlled trial has been designed to explore potential advantages of laser acupuncture in the management of neonatal pain because more data are required to provide information about its efficacy and safety. This trial is registered with DRKS00010122.

  11. Observed and Predicted Risk of Breast Cancer Death in Randomized Trials on Breast Cancer Screening.

    Science.gov (United States)

    Autier, Philippe; Boniol, Mathieu; Smans, Michel; Sullivan, Richard; Boyle, Peter

    2016-01-01

    The role of breast screening in breast cancer mortality declines is debated. Screening impacts cancer mortality through decreasing the number of advanced cancers with poor diagnosis, while cancer treatment works through decreasing the case-fatality rate. Hence, reductions in cancer death rates thanks to screening should directly reflect reductions in advanced cancer rates. We verified whether in breast screening trials, the observed reductions in the risk of breast cancer death could be predicted from reductions of advanced breast cancer rates. The Greater New York Health Insurance Plan trial (HIP) is the only breast screening trial that reported stage-specific cancer fatality for the screening and for the control group separately. The Swedish Two-County trial (TCT)) reported size-specific fatalities for cancer patients in both screening and control groups. We computed predicted numbers of breast cancer deaths, from which we calculated predicted relative risks (RR) and (95% confidence intervals). The Age trial in England performed its own calculations of predicted relative risk. The observed and predicted RR of breast cancer death were 0.72 (0.56-0.94) and 0.98 (0.77-1.24) in the HIP trial, and 0.79 (0.78-1.01) and 0.90 (0.80-1.01) in the Age trial. In the TCT, the observed RR was 0.73 (0.62-0.87), while the predicted RR was 0.89 (0.75-1.05) if overdiagnosis was assumed to be negligible and 0.83 (0.70-0.97) if extra cancers were excluded. In breast screening trials, factors other than screening have contributed to reductions in the risk of breast cancer death most probably by reducing the fatality of advanced cancers in screening groups. These factors were the better management of breast cancer patients and the underreporting of breast cancer as the underlying cause of death. Breast screening trials should publish stage-specific fatalities observed in each group.

  12. 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.

  13. 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

  14. 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

  15. When clinical trials compete: prioritising study recruitment.

    Science.gov (United States)

    Gelinas, Luke; Lynch, Holly Fernandez; Bierer, Barbara E; Cohen, I Glenn

    2017-12-01

    It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. 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/.

  16. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel.

    Science.gov (United States)

    Rongetti, Regiane Ladislau; Oliveira e Castro, Paulo de Tarso; Vieira, Renê Aloisio da Costa; Serrano, Sérgio Vicente; Mengatto, Mariana Fabro; Fregnani, José Humberto Tavares Guerreiro

    2014-01-01

    To evaluate the incidence of surgical site infection (SSI) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues. Observer-blind, randomized equivalence clinical trial with two arms (electrocautery versus conventional scalpel) which evaluated 133 women undergoing elective abdominal gynecologic oncology surgery. A simple randomization stratified by body mass index (BMI: 30 kg/m(2)) was carried out. Women were evaluated at 14 and 30 days following the operation. A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI. Group arms were balanced for all variables, excepted for surgical time, which was significantly higher in the electrocautery group (mean: 161.1 versus 203.5 min, P = 0.029). The rates of SSI were 7.4% and 9.7%, respectively, for the conventional scalpel and electrocautery groups (P = 0.756). The exploratory multivariate model identified body mass index ≥30 kg/m(2) (OR = 24.2, 95% CI: 2.8-212.1) and transverse surgical incision (OR = 8.1, 95% CI: 1.5-42.6) as independent risk factors for SSI. The type of scalpel used in surgery, when adjusted for these variables and the surgery time, was not a risk factor for SSI. This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different. These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI. NCT01410175 (Clinical Trials - NIH). Copyright © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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, ma...

  2. 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.

  3. 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 http://cwfis.cfs.nrcan.gc.ca/datamart.

  4. 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

  5. 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

  6. 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.

  7. An observational study on oesophageal variceal endoscopic ...

    African Journals Online (AJOL)

    An observational study on oesophageal variceal endoscopic injection sclerotherapy in patients with portal hypertension seen at the Centre for Clinical Research, ... The report concludes that variceal injection sclerotherapy is a useful method of treating oesophageal varices and can be performed on an out patient basis.

  8. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial.

    Science.gov (United States)

    Tolleson, Thaddeus R; O'Shea, J Conor; Bittl, John A; Hillegass, William B; Williams, Kathryn A; Levine, Glenn; Harrington, Robert A; Tcheng, James E

    2003-02-05

    We evaluated the relationship between the degree of heparin anticoagulation and clinical efficacy and bleeding in patients undergoing contemporary percutaneous coronary intervention (PCI) with stent implantation. Despite universal acceptance of heparin anticoagulation as a standard of care in PCI, considerable controversy still exists regarding the appropriate dosing of heparin. The study population (n = 2,064) comprised all patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. The index activated clotting time (ACT) was defined as the ACT measured after the last heparin dose and before first device activation and was correlated with outcome and bleeding events. No association was observed between decreasing ACT levels and the rate of ischemic events in the treatment or placebo arms. The incidence of the primary composite end point (death, myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy at 48 h) was actually lowest in the lowest ACT tertile for both the placebo (10.0%) and treatment groups (6.1%). When analyzed by tertile, major bleeding rates did not increase in the lowest ACT tertile in patients given placebo (0.6%) versus those receiving eptifibatide (0.7%). Major bleeding rates increased as the ACT increased in the eptifibatide-treated patients. Ischemic end points in patients undergoing contemporary PCI with stent placement do not increase by decreasing ACT levels, at least to a level of 200 s. Bleeding events do increase with increasing ACT levels and are enhanced with eptifibatide treatment. An ACT of 200 to 250 s is reasonable in terms of efficacy and safety with the use of contemporary technology and pharmacotherapy.

  9. 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.

  10. 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......-BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of ... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

  11. 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.

  12. 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.

  13. A random walk model for evaluating clinical trials involving serial observations.

    Science.gov (United States)

    Hopper, J L; Young, G P

    1988-05-01

    For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

  14. Urinary Tract Infection Antibiotic Trial Study Design: A Systematic Review.

    Science.gov (United States)

    Basmaci, Romain; Vazouras, Konstantinos; Bielicki, Julia; Folgori, Laura; Hsia, Yingfen; Zaoutis, Theoklis; Sharland, Mike

    2017-12-01

    Urinary tract infections (UTIs) represent common bacterial infections in children. No guidance on the conduct of pediatric febrile UTI clinical trials (CTs) exist. To assess the criteria used for patient selection and the efficacy end points in febrile pediatric UTI CTs. Medline, Embase, Cochrane central databases, and clinicaltrials.gov were searched between January 1, 1990, and November 24, 2016. We combined Medical Subject Headings terms and free-text terms for "urinary tract infections" and "therapeutics" and "clinical trials" in children (0-18 years), identifying 3086 articles. Two independent reviewers assessed study quality and performed data extraction. We included 40 CTs in which a total of 4381 cases of pediatric UTIs were investigated. Positive urine culture results and fever were the most common inclusion criteria (93% and 78%, respectively). Urine sampling method, pyuria, and colony thresholds were highly variable. Clinical and microbiological end points were assessed in 88% and 93% of the studies, respectively. Timing for end point assessment was highly variable, and only 3 studies (17%) out of the 18 performed after the Food and Drug Administration 1998 guidance publication assessed primary and secondary end points consistently with this guidance. Our limitations included a mixed population of healthy children and children with an underlying condition. In 6 trials, researchers studied a subgroup of patients with afebrile UTI. We observed a wide variability in the microbiological inclusion criteria and the timing for end point assessment. The available guidance for adults appear not to be used by pediatricians and do not seem applicable to the childhood UTI. A harmonized design for pediatric UTIs CT is necessary. Copyright © 2017 by the American Academy of Pediatrics.

  15. 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.

  16. 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.

  17. 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

    DEFF Research Database (Denmark)

    Lindholdt, Louise; Labriola, Merete; Nielsen, Claus Vinther

    2017-01-01

    INTRODUCTION: 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...... (LBP). METHODS: 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. RESULTS: The logistic regression analysis showed no difference in labour market participation for patients in the two groups...

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

    Science.gov (United States)

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

    2013-04-30

    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 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 algorithms based on image-registration as in iPlan, it is apparent that agreement between observer and automatic segmentation will be a function of patient-specific image characteristics, particularly for anatomy with poor contrast definition. For this reason, it is suggested that automatic registration based on transformation of a single reference dataset

  19. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

    Science.gov (United States)

    Logvinov, Ilana

    2014-03-01

    Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. 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.

  1. 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.

  2. 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

    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......)]) served as effect size. RESULTS: The inclusion criteria yielded 25 trials (3,458 patients). Glucosamine moderately reduced pain (SMD -0.51 [95% CI -0.72, -0.30]), although a high level of between-trial inconsistency was observed (I(2) = 88%). The single most important explanation (i.e., covariate......) 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...

  3. Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

    Science.gov (United States)

    Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

    2016-06-01

    To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. 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.

  5. AECL's excavation stability study - summary of observations

    International Nuclear Information System (INIS)

    Read, R.S.; Chandler, N.A.

    1996-05-01

    The Excavation Stability Study (ESS) was conducted at the 420 Level of the Underground Research Laboratory (URL) to evaluate stability and the extent of excavation damage in tunnels as a function of tunnel geometry and orientation, geology, and excavation method. A series of ovaloid and circular openings were used to achieve different boundary stress levels and near-field stress distributions to assess the effect of tunnel geometry on damage development. Several of these openings had sections in both granite and granodiorite lithology, providing a comparison of damage in rock types with different strength characteristics. Damage around circular tunnels (one excavated by drill-and-blast, the other by mechanical means) was also investigated. The study.showed that mechanically stable openings can be excavated in the most adverse stress conditions at the 420 Level of the URL. In addition, it was shown that tunnel stability is sensitive to tunnel shape, variations in geology, and to some extent, the excavation method. Findings of the study are relevant in developing design criteria, and in assessing the feasibility of constructing large ovaloid openings in adverse stress conditions. This report summarizes the preliminary observations related to tunnel stability and excavation damage. (author). 8 refs., 7 tabs., 23 figs

  6. 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...

  7. [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...... 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...... 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...

  8. Theoretical and observational studies of stellar activity

    International Nuclear Information System (INIS)

    Schmitt, J.H.M.M.

    1984-01-01

    In the theoretical part of this thesis, doubly-diffusive MHD instabilities are studied as a means of breaking up a diffuse magnetic field at the bottom of the solar convection zone. The analysis is linear and local, and assumes short meridional wavelengths; the effects of rotation and diffusion of vorticity, magnetic fields and heat are included. Results show that the instability depends sensitively on the temperature stratification, but rather insensitively on the assumed magnetic field configuration; instability time scales considerably less than the solar cycle period can be easily obtained. In the observational part of the thesis, results are reported of a survey of the x-ray emission of stars with shallow connection zones to study the onset of convection and dynamo activity along the main sequence. Complications arising from stellar multiplicity are discussed extensively; it is demonstrated that binaries have statistically higher x-ray luminosities; and it is shown that physical parameters can only be deduced from single stars. It is further shown that the x-ray luminosities of stars with spectral type in the color range 0.1 less than or equal to B. V less than or equal to 0.5 increase rapidly, whereas stars with B. V approx. 0.0 appear to have no intrinsic x-ray emission at presently detectable levels

  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. 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.

  11. Late onset rheumatoid arthritis an observational study.

    Science.gov (United States)

    Rexhepi, Sylejman; Rexhepi, Mjellma; Sahatçiu-Meka, Vjollca; Rexhepi, Blerta; Bahtiri, Elton; Mahmutaj, Vigan

    Rheumatoid arthritis (RA) may have an onset at older age. The onset of the disease at the age of 60 and over is called late-onset rheumatoid arthritis (LORA). The aim of this study was to analyze the clinical, laboratory, radiological, and treatment characteristics of patients with LORA compared to those with early-onset RA (EaORA), provided that all the patients had an approximately equal duration of the disease. This is an observational single-center study, which involved 120 patients with an established diagnosis of RA, of which 60 patients had LORA, and 60 patients EaORA. The disease activity, measured by the Disease Activity Score 28 (DAS28-ESR), was significantly higher in the LORA group compared to the EaORA group (p0.05), while the number of patients positive for anti-citrullinated protein antibody (ACPA) was signifi cantly greater in the EaORA group (p<0.05). The values of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were significantly higher in the LORA than in the EaORA group. Hemoglobin levels were lower in the LORA group (11.96±1.64 g/dL) than in the EaORA group (12.18±1.56 g/dL). The most used disease-modifying antirheumatic drugs (DMARDs) were methotrexate and sulfasalazine, while biological drugs were not used. In conclusion, based on the results of our study, LORA has some features that distinguish it from EaORA, such as higher disease activity, more frequent involvement of large joints, and more pronounced structural damage. This should be taken in account in clinical practice, especially regarding treatment choices.

  12. 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

  13. Consent for pediatric anesthesia: an observational study.

    Science.gov (United States)

    Lagana, Zoe; Foster, Andrew; Bibbo, Adriana; Dowling, Kate; Cyna, Allan M

    2012-08-01

    Informed consent prior to anesthesia is an important part of the pediatric pre-anesthetic consultation. This study aimed to observe and identify the number and nature of the anesthesia risks considered and communicated to parents/guardians and children during the pediatric informed consent process on the day of elective surgery. A convenience sample of anesthetists had their pre-anesthesia consultations voice recorded, prior to elective surgery, during a 4-month period at the largest tertiary referral centre for pediatric care in South Australia. A data collection form was used to note baseline demographic data, and voice recording transcripts were independently documented by two researchers and subsequently compared for accuracy regarding the number and nature of risks discussed. Of the 96 voice recordings, 91 (92%) were suitable for the analysis. The five most commonly discussed risks were as follows: nausea and vomiting (36%); sore throat (35%); allergy (29%); hypoxia (25%); and emergence delirium (19%). Twenty-seven pre-anesthetic consultations (30%) were found to have had no discussion of anesthetic risk at all while a further 23 consultations (26%) incorporated general statements inferring that anesthesia carried risks, but with no elaboration about their nature, ramifications or incidence. The median number of risks (IQR) specifically mentioned per consultation was higher, 3 (1) vs 1 (1), P anesthesia experience odds ratio 0.34, 95% CI [0.13, 0.87], P = 0.025. The pediatric anesthesia risk discussion is very variable. Trainees tend to discuss more specific risks than consultants and a patient's previous experience of anesthesia was associated with a more limited discussion of anesthesia risk. © 2011 Blackwell Publishing Ltd.

  14. 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.

  15. 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.

  16. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  17. 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.

  18. Study partners should be required in preclinical Alzheimer's disease trials.

    Science.gov (United States)

    Grill, Joshua D; Karlawish, Jason

    2017-12-06

    In an effort to intervene earlier in Alzheimer's disease (AD), clinical trials are testing promising candidate therapies in preclinical disease. Preclinical AD trial participants are cognitively normal, functionally independent, and autonomous decision-makers. Yet, like AD dementia trials, preclinical trials require dual enrollment of a participant and a knowledgeable informant, or study partner. The requirement of dyadic enrollment is a barrier to recruitment and may present unique ethical challenges. Despite these limitations, the requirement should continue. Study partners may be essential to ensure participant safety and wellbeing, including overcoming distress related to biomarker disclosure and minimizing risk for catastrophic reactions and suicide. The requirement may maximize participant retention and ensure data integrity, including that study partners are the source of data that will ultimately instruct whether a new treatment has a clinical benefit and meaningful impact on the population health burden associated with AD. Finally, study partners are needed to ensure the scientific and clinical value of trials. Preclinical AD will represent a new model of care, in which persons with no symptoms are informed of probable cognitive decline and eventual dementia. The rationale for early diagnosis in symptomatic AD is equally applicable in preclinical AD-to minimize risk, maximize quality of life, and ensure optimal planning and communication. Family members and other sources of support will likely be essential to the goals of this new model of care for preclinical AD patients and trials must instruct this clinical practice.

  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. 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.

  1. 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…

  2. 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

  3. Observational study of Herbig-Haro nebulae

    International Nuclear Information System (INIS)

    Brugel, E.W.

    1981-01-01

    Spectrophotometric data have been obtained for twelve Herbig-Haro nebulae with the multichannel spectrometer on the Mt. Palomar 5.08 meter telescope and with the image intensified dissector scanner on the Kitt Peak 2.13 meter telescope. Energy distributions of the continuous spectra of the Herbig-Haro objects H-H 1 (NW), H-H 2A, H-H 2G, H-H 2H, H-H 24A and H-H 32 have been determined in the wavelength range 3300 to 8000A. The signal-to-noise ratio has been improved in comparison to an earlier attempt to measure the continuum in H-H 1 and H-H 2H. Reddening corrections are based on Miller's [SII] method. The [FeII] emission line spectra have also been utilized as a secondary method for determining the interstellar reddening. In all continua the flux F/sub lambda/ increases rapidly with decreasing wavelength after the small scale structure has been averaged out. A power law interpolation F/sub lambda/ proportional lambda/sup -n/ demonstrates that for all observed H-H objects n lies in the range between 2.04 (H-H 2A, H-H 2H) and 2.92 (H-H 32). The relation of these results to recent I.U.E. observations of H-H 1 is discussed. It is also found that the ratio of the total optical continuum flux to Hβ flux is almost the same for all observed H-H objects with the sole exception of H-H 24A in which the continuum is considerably stronger than in other objects. This fact leads to difficulties in the usual dust scattering hypothesis for the interpretation of H-H continua. It is argued, if these energy distributions are really due to dust scattering in stellar continua as has been usually assumed, the original source must be a hot object and cannot be a T Tauri star.An interpretation in terms of transition radiation (as suggested by Gurzadyan) does not seem to be possible because the observed rise of F/sub lambda/ towards the ultraviolet is too steep

  4. 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.

  5. Geomagnetic Observations for Main Field Studies

    DEFF Research Database (Denmark)

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

    2010-01-01

    Direct measurements of the geomagnetic field have been made for more than 400 years, beginning with individual determinations of the angle between geographic and magnetic North. This was followed by the start of continuous time series of full vector measurements at geomagnetic observatories...... 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....

  6. 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.

  7. 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

  8. 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.

  9. 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...... characteristics. Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes....

  10. 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.

  11. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

    Science.gov (United States)

    Briel, Matthias; Lane, Melanie; Montori, Victor M; Bassler, Dirk; Glasziou, Paul; Malaga, German; Akl, Elie A; Ferreira-Gonzalez, Ignacio; Alonso-Coello, Pablo; Urrutia, Gerard; Kunz, Regina; Culebro, Carolina Ruiz; da Silva, Suzana Alves; Flynn, David N; Elamin, Mohamed B; Strahm, Brigitte; Murad, M Hassan; Djulbegovic, Benjamin; Adhikari, Neill KJ; Mills, Edward J; Gwadry-Sridhar, Femida; Kirpalani, Haresh; Soares, Heloisa P; Elnour, Nisrin O Abu; You, John J; Karanicolas, Paul J; Bucher, Heiner C; Lampropulos, Julianna F; Nordmann, Alain J; Burns, Karen EA; Mulla, Sohail M; Raatz, Heike; Sood, Amit; Kaur, Jagdeep; Bankhead, Clare R; Mullan, Rebecca J; Nerenberg, Kara A; Vandvik, Per Olav; Coto-Yglesias, Fernando; Schünemann, Holger; Tuche, Fabio; Chrispim, Pedro Paulo M; Cook, Deborah J; Lutz, Kristina; Ribic, Christine M; Vale, Noah; Erwin, Patricia J; Perera, Rafael; Zhou, Qi; Heels-Ansdell, Diane; Ramsay, Tim; Walter, Stephen D; Guyatt, Gordon H

    2009-01-01

    Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed

  12. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2

    Directory of Open Access Journals (Sweden)

    Mullan Rebecca J

    2009-07-01

    Full Text Available Abstract Background Randomized clinical trials (RCTs stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1, which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic t

  13. Efficacy and safety of a hexanic extract of Serenoa repens (Permixon® ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): Systematic review and meta-analysis of randomized controlled trials and observational studies.

    Science.gov (United States)

    Vela-Navarrete, Remigio; Alcaraz, Antonio; Rodríguez-Antolín, Alfredo; Miñana López, Bernardino; Fernández-Gómez, Jesús M; Angulo, Javier C; Castro Díaz, David; Romero-Otero, Javier; Brenes, Francisco J; Carballido, Joaquín; Molero García, José M; Fernández-Pro Ledesma, Antonio; Cózar Olmos, José Manuel; Manasanch Dalmau, José; Subirana Cachinero, Isaac; Herdman, Michael; Ficarra, Vincenzo

    2018-04-25

    To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon), at a dose of 320 mg daily, as monotherapy for the treatment of LUTS/BPH. Systematic review and meta-analysis of randomized and observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge [ISI], Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data was collected on IPSS score, peak urinary flow (Qmax), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADR). Data obtained from randomized controlled trials (RCT) and observational studies (OS) were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies which included patients on longer-term treatment (≥one year). Data from 27 studies (15 RCTs and 12 OS) were included for meta-analysis (total N=5,800). Compared with placebo, the HESr was associated with 0.64 (95% CI -0.98 to -0.31) fewer voids per night (p=0.0001) and an additional mean increase in Qmax of 2.75 mL/s (95% CI 0.57 to 4.93; p=0.01). When compared with alpha-blockers, the HESr showed similar improvements on IPSS (WMD 0.57; 95%CI, -0.27 to 1.42; p=0.18) and a comparable increase in Qmax to tamsulosin (WMD -0.02; 95%CI, -0.71 to 0.66; p=0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5ARIs. Analysis of all available published data for the HESr showed a mean improvement in IPSS score from baseline of -5.73 points (95% CI -6.91 to -4.54; pBPH. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  14. 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

  15. 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.

  16. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Liu, Zhishun; Wang, Yang; Xu, Huanfang; Wu, Jiani; He, Liyun; Jiang, John Yi; Yan, Shiyan; Du, Ruosang; Liu, Baoyan

    2014-06-21

    Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture. In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made. Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms. ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

  17. 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.

  18. Diagnosing displaced four-part fractures of the proximal humerus: a review of observer studies

    DEFF Research Database (Denmark)

    Brorson, Stig; Bagger, Jens; Sylvest, Annette

    2009-01-01

    Displaced four-part fractures comprise 2-10 % of all proximal humeral fractures. The optimal treatment is unclear and randomised trials are needed. The conduct and interpretation of such trials is facilitated by a reproducible fracture classification. We aimed at quantifying observer agreement...... on the classification of displaced four-part fractures according to the Neer system. Published and unpublished data from five observer studies were reviewed. Observers agreed less on displaced four-part fractures than on the overall Neer classification. Mean kappa values for interobserver agreement ranged from 0.......16 to 0.48. Specialists agreed slightly more than fellows and residents. Advanced imaging modalities (CT and 3D CT) seemed to contribute more to classification of displaced four-part patterns than in less complex fracture patterns. Low observer agreement may challenge the clinical approach to displaced...

  19. Management of rheumatic chorea: an observational study

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    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.

  20. Body characteristics, [corrected] dietary protein and body weight regulation. Reconciling conflicting results from intervention and observational studies?

    Directory of Open Access Journals (Sweden)

    Mikkel Z Ankarfeldt

    Full Text Available Physiological evidence indicates that high-protein diets reduce caloric intake and increase thermogenic response, which may prevent weight gain and regain after weight loss. Clinical trials have shown such effects, whereas observational cohort studies suggest an association 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 into clinical trials.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, 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.Trial participants were generally heavier, had larger waist circumference and larger fat mass than the participants in the entire DCH cohort. A better weight maintenance in the high-protein group compared to the low protein group was observed in the subgroups of the DCH cohort matching body characteristics of the trial participants.This modified observational study, minimized the differences between the RCT and observational data with regard to dietary intake, participant characteristics and statistical analysis. Compared with low protein diet the high protein diet was associated with better weight maintenance when individuals with greater body mass index and waist circumference were analyzed. Selecting subsets of large-scale observational cohort studies with similar characteristics as participants in clinical trials may reconcile the otherwise conflicting

  1. Results of an Oncology Clinical Trial Nurse Role Delineation Study.

    Science.gov (United States)

    Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

    2017-09-01

    To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

  2. 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

  3. [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

  4. Benchmarking Controlled Trial—a novel concept covering all observational effectiveness studies

    Science.gov (United States)

    Malmivaara, Antti

    2015-01-01

    Abstract The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals. PMID:25965700

  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 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

  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. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

    2015-03-15

    Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

  9. Transabdominal amnioinfusion for preterm premature rupture of membranes: a systematic review and metaanalysis of randomized and observational studies.

    Science.gov (United States)

    Porat, Shay; Amsalem, Hagai; Shah, Prakesh S; Murphy, Kellie E

    2012-11-01

    The purpose of this study was to review systematically the efficacy of transabdominal amnioinfusion (TA) in early preterm premature rupture of membranes (PPROM). We conducted a literature search of EMBASE, MEDLINE, and ClinicalTrials.gov databases and identified studies in which TA was used in cases of proven PPROM and oligohydramnios. Risk of bias was assessed for observational studies and randomized controlled trials. Primary outcomes were latency period and perinatal mortality rates. Four observational studies (n = 147) and 3 randomized controlled trials (n = 165) were eligible. Pooled latency period was 14.4 (range, 8.2-20.6) and 11.41 (range -3.4 to 26.2) days longer in the TA group in the observational and the randomized controlled trials, respectively. Perinatal mortality rates were reduced among the treatment groups in both the observational studies (odds ratio, 0.12; 95% confidence interval, 0.02-0.61) and the randomized controlled trials (odds ratio, 0.33; 95% confidence interval, 0.10-1.12). Serial TA for early PPROM may improve early PPROM-associated morbidity and mortality rates. Additional adequately powered randomized control trials are needed. Copyright © 2012 Mosby, Inc. All rights reserved.

  10. 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.

  11. Study of neurontin: titrate to effect, profile of safety (STEPS) trial: a narrative account of a gabapentin seeding trial.

    Science.gov (United States)

    Krumholz, Samuel D; Egilman, David S; Ross, Joseph S

    2011-06-27

    Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail. We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation. Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in 2 published articles. The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

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

    Science.gov (United States)

    Petrini, Carlo

    2011-01-01

    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.

  13. 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.

  14. 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

  15. Effect of Ramadan Fasting on Body Weight, (BP) and Biochemical Parameters in Middle Aged Hypertensive Subjects: An Observational Trial.

    Science.gov (United States)

    M, Salahuddin; Ah, Sayed Ashfak; Sr, Syed; Km, Badaam

    2014-03-01

    Ramadan fasting is a religious obligation which is practised by Muslim population all over the world. However, there is scarcity of scientific literature regarding its effects on health determinants in cardiovascular disturbances like hypertension. The present study was done to assess the (BP), body weight and serum cholesterol changes over the period of Ramadan fasting in patients with hypertension. Materails And Methods:This prospective observational trial was done on 15 hypertensive subjects who were in the age group of 35 to 65 years, who were determined to complete Ramadan fast. All subjects were on antihypertensive therapy. Outcome measures of (BP), body weight and serum cholesterol were assessed in all the subjects before and after Ramadan month. Mean age of subjects was 44.6 ± 5.62 years. Systolic BP decreased from 148 ± 19.6 to 132.5 ± 17.9 mm of Hg. The decrease of 15.5 units (95% CI: 7.5 to 24.4) was statistically significant (p = 0.0009). Diastolic BP decreased from 90.4 ± 7.8 to 81.1 ± 6.3 mm of Hg. The decrease of 9.3 units (95% CI: 5.7 to 13) was statistically significant (p Ramadan fasting duration. However there was no change found in serum cholesterol levels.

  16. 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.

  17. 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

  18. 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...

  19. [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.

  20. 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.

  1. 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

  2. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  3. 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 SMD ... 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...

  4. Observational studies in systematic [corrected] reviews of comparative effectiveness: AHRQ and the Effective Health Care Program.

    Science.gov (United States)

    Norris, Susan L; Atkins, David; Bruening, Wendy; Fox, Steven; Johnson, Eric; Kane, Robert; Morton, Sally C; Oremus, Mark; Ospina, Maria; Randhawa, Gurvaneet; Schoelles, Karen; Shekelle, Paul; Viswanathan, Meera

    2011-11-01

    Systematic reviewers disagree about the ability of observational studies to answer questions about the benefits or intended effects of pharmacotherapeutic, device, or procedural interventions. This study provides a framework for decision making on the inclusion of observational studies to assess benefits and intended effects in comparative effectiveness reviews (CERs). The conceptual model and recommendations were developed using a consensus process by members of the methods workgroup of the Effective Health Care Program of the Agency for Healthcare Research and Quality. In considering whether to use observational studies in CERs for addressing beneficial effects, reviewers should answer two questions: (1) Are there gaps in the evidence from randomized controlled trials (RCTs)? (2) Will observational studies provide valid and useful information? The latter question involves the following: (a) refocusing the study questions on gaps in the evidence from RCTs, (b) assessing the risk of bias of the body of evidence of observational studies, and (c) assessing whether available observational studies address the gap review questions. Because it is unusual to find sufficient evidence from RCTs to answer all key questions concerning benefit or the balance of benefits and harms, comparative effectiveness reviewers should routinely assess the appropriateness of inclusion of observational studies for questions of benefit. Furthermore, reviewers should explicitly state the rationale for inclusion or exclusion of observational studies when conducting CERs. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. 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

  6. 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…

  7. 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.

  8. 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...

  9. 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...

  10. 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....

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. Clinical Trial Results Summary for Laypersons: A User Testing Study.

    Science.gov (United States)

    Raynor, D K; Myers, L; Blackwell, K; Kress, B; Dubost, A; Joos, A

    2018-01-01

    To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary-a new European requirement. "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

  16. The Bipolar Interactive Psychoeducation (BIPED study: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Jones Ian

    2009-08-01

    Full Text Available Abstract Background Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder. Methods/design The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness. Discussion Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients. Trial registration Current Controlled Trials

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  18. 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

  19. Evaluation of Multiclass Model Observers in PET LROC Studies

    Science.gov (United States)

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

    2007-02-01

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

  20. 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.

  1. 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.)

  2. 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.)

  3. Stroke risk and NSAIDs: A systematic review of observational studies

    NARCIS (Netherlands)

    C. Varas-Lorenzo (Cristina); N. Riera-Guardia (Nuria); B. Calingaert (Brian); J. Castellsague (Jordi); A. Pariente (Antoine); L. Scotti (Lorenza); M.C.J.M. Sturkenboom (Miriam); S. Perez-Gutthann (Susana)

    2011-01-01

    textabstractAims: To perform a quantitative systematic review of observational studies on the risk of stroke associated with the use of individual NSAIDs. Methods and results: Searches were conducted using the Medline database within PubMed (1990-2008). Observational cohort or case-control studies

  4. 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....

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

    African Journals Online (AJOL)

    ARTICLE. An observational study on the relationship between plasma ... To study plasma vitamin C, oxidative stress, hyperglycaemia, endothelial dysfunction and outcome in septic shock. ..... with critical illness,[6,7,16] and excess losses of.

  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. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study.

    Science.gov (United States)

    Wallach, Joshua D; Ciani, Oriana; Pease, Alison M; Gonsalves, Gregg S; Krumholz, Harlan M; Taylor, Rod S; Ross, Joseph S

    2018-03-21

    The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product's actual clinical effect. This study aims to compare the treatment effects among pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease with those observed among postapproval trials for the same indication. We searched Drugs@FDA and PubMed to identify published randomized superiority design pivotal trials for all novel drugs initially approved by the FDA between 2005 and 2012 based on surrogate markers as primary endpoints and published postapproval trials using the same surrogate markers or patient-relevant outcomes as endpoints. Summary ratio of odds ratios (RORs) and difference between standardized mean differences (dSMDs) were used to quantify the average difference in treatment effects between pivotal and matched postapproval trials. Between 2005 and 2012, the FDA approved 88 novel drugs for 90 indications based on one or multiple pivotal trials using surrogate markers of disease. Of these, 27 novel drugs for 27 indications were approved based on pivotal trials using surrogate markers as primary endpoints that could be matched to at least one postapproval trial, for a total of 43 matches. For nine (75.0%) of the 12 matches using the same non-continuous surrogate markers as trial endpoints, pivotal trials had larger treatment effects than postapproval trials. On average, treatment effects were 50% higher (more beneficial) in the pivotal than the postapproval trials (ROR 1.5; 95% confidence interval CI 1.01-2.23). For 17 (54.8%) of the 31 matches using the same continuous surrogate markers as trial endpoints, pivotal trials had larger treatment effects than the postapproval trials. On average, there was no difference in treatment effects between pivotal and postapproval trials (dSMDs 0.01; 95

  8. Risk factors for failed conversion of labor epidural analgesia to cesarean delivery anesthesia: a systematic review and meta-analysis of observational trials.

    Science.gov (United States)

    Bauer, M E; Kountanis, J A; Tsen, L C; Greenfield, M L; Mhyre, J M

    2012-10-01

    This systematic review and meta-analysis evaluates evidence for seven risk factors associated with failed conversion of labor epidural analgesia to cesarean delivery anesthesia. Online scientific literature databases were searched using a strategy which identified observational trials, published between January 1979 and May 2011, which evaluated risk factors for failed conversion of epidural analgesia to anesthesia or documented a failure rate resulting in general anesthesia. 1450 trials were screened, and 13 trials were included for review (n=8628). Three factors increase the risk for failed conversion: an increasing number of clinician-administered boluses during labor (OR=3.2, 95% CI 1.8-5.5), greater urgency for cesarean delivery (OR=40.4, 95% CI 8.8-186), and a non-obstetric anesthesiologist providing care (OR=4.6, 95% CI 1.8-11.5). Insufficient evidence is available to support combined spinal-epidural versus standard epidural techniques, duration of epidural analgesia, cervical dilation at the time of epidural placement, and body mass index or weight as risk factors for failed epidural conversion. The risk of failed conversion of labor epidural analgesia to anesthesia is increased with an increasing number of boluses administered during labor, an enhanced urgency for cesarean delivery, and care being provided by a non-obstetric anesthesiologist. Further high-quality studies are needed to evaluate the many potential risk factors associated with failed conversion of labor epidural analgesia to anesthesia for cesarean delivery. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

    Science.gov (United States)

    Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

    2014-11-01

    The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014

  10. 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.

  11. 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

  12. 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.

  13. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  14. Case-Control Studies - An Efficient Observational Study Design

    NARCIS (Netherlands)

    van Stralen, Karlijn J.; Dekker, Friedo W.; Zoccali, Carmine; Jager, Kitty J.

    2010-01-01

    Case-control studies are an efficient research method for investigating risk factors of a disease. The method involves the comparison of the odds of exposure in a patient group with that of the odds of exposure in a control group. As only a minority of the population is included in the study, less

  15. 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)

  16. 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.

  17. 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 of Medi...

  18. Changes in relative and absolute concentrations of plasma phospholipid fatty acids observed in a randomized trial of Omega-3 fatty acids supplementation in Uganda.

    Science.gov (United States)

    Song, Xiaoling; Diep, Pho; Schenk, Jeannette M; Casper, Corey; Orem, Jackson; Makhoul, Zeina; Lampe, Johanna W; Neuhouser, Marian L

    2016-11-01

    Expressing circulating phospholipid fatty acids (PLFAs) in relative concentrations has some limitations: the total of all fatty acids are summed to 100%; therefore, the values of individual fatty acid are not independent. In this study we examined if both relative and absolute metrics could effectively measure changes in circulating PLFA concentrations in an intervention trial. 66 HIV and HHV8 infected patients in Uganda were randomized to take 3g/d of either long-chain omega-3 fatty acids (1856mg EPA and 1232mg DHA) or high-oleic safflower oil in a 12-week double-blind trial. Plasma samples were collected at baseline and end of trial. Relative weight percentage and absolute concentrations of 41 plasma PLFAs were measured using gas chromatography. Total cholesterol was also measured. Intervention-effect changes in concentrations were calculated as differences between end of 12-week trial and baseline. Pearson correlations of relative and absolute concentration changes in individual PLFAs were high (>0.6) for 37 of the 41 PLFAs analyzed. In the intervention arm, 17 PLFAs changed significantly in relative concentration and 16 in absolute concentration, 15 of which were identical. Absolute concentration of total PLFAs decreased 95.1mg/L (95% CI: 26.0, 164.2; P=0.0085), but total cholesterol did not change significantly in the intervention arm. No significant change was observed in any of the measurements in the placebo arm. Both relative weight percentage and absolute concentrations could effectively measure changes in plasma PLFA concentrations. EPA and DHA supplementation changes the concentrations of multiple plasma PLFAs besides EPA and DHA.Both relative weight percentage and absolute concentrations could effectively measure changes in plasma phospholipid fatty acid (PLFA) concentrations. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. An observational study of road safety around selected primary ...

    African Journals Online (AJOL)

    Materials and Methods: A multistage sampling technique was used to select 46 of the 74 schools in the study area. Some (11) of the selected schools were sited within the same premises and shared a common entrance; thus a total of 35 school premises were eventually observed. Trained research assistants observed the ...

  20. 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...... 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...

  1. 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

    , 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......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...

  2. 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

    difference (SMD), the protocols for the reviews and the trial reports (n=45) were retrieved. DATA EXTRACTION: Five experienced methodologists and five PhD students independently extracted data from the trial reports for calculation of the first SMD result in each review. The observers did not have access...... to the reviews but to the protocols, where the relevant outcome was highlighted. The agreement was analysed at both trial and meta-analysis level, pairing the observers in all possible ways (45 pairs, yielding 2025 pairs of trials and 450 pairs of meta-analyses). Agreement was defined as SMDs that differed less...... than 0.1 in their point estimates or confidence intervals. RESULTS: The agreement was 53% at trial level and 31% at meta-analysis level. Including all pairs, the median disagreement was SMD=0.22 (interquartile range 0.07-0.61). The experts agreed somewhat more than the PhD students at trial level (61...

  3. 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.

  4. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

    Directory of Open Access Journals (Sweden)

    Price Jackie F

    2011-01-01

    Full Text Available Abstract Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA trial (N = 11, and AAA trial participants who had stopped taking the trial medication (N = 11. A focus group with further participants who had stopped taking the trial medication (N = 6. (Total participants N = 28. Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

  5. Observational studies and the difficult quest for causality

    DEFF Research Database (Denmark)

    Lipsitch, Marc; Jha, Ayan; Simonsen, Lone

    2016-01-01

    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...... 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...... as 'ecological'. Such designs are the only observational study design that can measure the overall effect of a vaccination programme [indirect (herd) as well as direct effects], and are in fact already an important part of the evidence base for several vaccines currently in use. Despite the great strides towards...

  6. Pain in neurosurgically treated patients: A prospective observational study

    NARCIS (Netherlands)

    M. Klimek (Markus); J.F. Ubben (Johannes); J. Ammann (Jan); K. Borner (Katy); J. Klein (Jan); S.J.C. Verbrugge (Serge)

    2006-01-01

    textabstractObject. This is the first observational study to compare perioperative pain character and intensity in patients undergoing different types of elective neurosurgical procedures. Methods. A structured questionnaire was used to inquire about pain intensity, character, and management during

  7. 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.

  8. Clinical Impact Research – how to choose experimental or observational intervention study?

    Science.gov (United States)

    Malmivaara, Antti

    2016-01-01

    Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

  9. Clinical Impact Research - how to choose experimental or observational intervention study?

    Science.gov (United States)

    Malmivaara, Antti

    2016-11-01

    Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

  10. 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...

  11. 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

  12. Neonatal ECMO Study of Temperature (NEST - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Juszczak Edmund

    2010-04-01

    Full Text Available Abstract Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III at age of 2 years (24 - 27 months. Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For

  13. 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

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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.

  19. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

    2017-01-26

    Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

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

    DEFF Research Database (Denmark)

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

    2018-01-01

    these to patient-important outcomes. With this protocol and statistical analysis plan we describe the methods used to obtain data and the details of the planned analyses. Methods: The INFECT study is a multicentre, prospective observational cohort study. Patients with NSTIs are enrolled in five Scandinavian......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...

  1. 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...

  2. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.

    Science.gov (United States)

    Eborall, Helen C; Stewart, Marlene C W; Cunningham-Burley, Sarah; Price, Jackie F; Fowkes, F Gerry R

    2011-01-11

    Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28). Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. ISRCTN66587262.

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

    Science.gov (United States)

    Suissa, Samy

    2018-01-01

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

  4. 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.

  5. Assessing a Novel Method to Reduce Anesthesia Machine Contamination: A Prospective, Observational Trial

    Directory of Open Access Journals (Sweden)

    Chuck J. Biddle

    2018-01-01

    Full Text Available Background. Anesthesia machines are known reservoirs of bacterial species, potentially contributing to healthcare associated infections (HAIs. An inexpensive, disposable, nonpermeable, transparent anesthesia machine wrap (AMW may reduce microbial contamination of the anesthesia machine. This study quantified the density and diversity of bacterial species found on anesthesia machines after terminal cleaning and between cases during actual anesthesia care to assess the impact of the AMW. We hypothesized reduced bioburden with the use of the AMW. Methods. In a prospective, experimental research design, the AMW was used in 11 surgical cases (intervention group and not used in 11 control surgical cases. Cases were consecutively assigned to general surgical operating rooms. Seven frequently touched and difficult to disinfect “hot spots” were cultured on each machine preceding and following each case. The density and diversity of cultured colony forming units (CFUs between the covered and uncovered machines were compared using Wilcoxon signed-rank test and Student’s t-tests. Results. There was a statistically significant reduction in CFU density and diversity when the AMW was employed. Conclusion. The protective effect of the AMW during regular anesthetic care provides a reliable and low-cost method to minimize the transmission of pathogens across patients and potentially reduces HAIs.

  6. Assessing a Novel Method to Reduce Anesthesia Machine Contamination: A Prospective, Observational Trial.

    Science.gov (United States)

    Biddle, Chuck J; George-Gay, Beverly; Prasanna, Praveen; Hill, Emily M; Davis, Thomas C; Verhulst, Brad

    2018-01-01

    Anesthesia machines are known reservoirs of bacterial species, potentially contributing to healthcare associated infections (HAIs). An inexpensive, disposable, nonpermeable, transparent anesthesia machine wrap (AMW) may reduce microbial contamination of the anesthesia machine. This study quantified the density and diversity of bacterial species found on anesthesia machines after terminal cleaning and between cases during actual anesthesia care to assess the impact of the AMW. We hypothesized reduced bioburden with the use of the AMW. In a prospective, experimental research design, the AMW was used in 11 surgical cases (intervention group) and not used in 11 control surgical cases. Cases were consecutively assigned to general surgical operating rooms. Seven frequently touched and difficult to disinfect "hot spots" were cultured on each machine preceding and following each case. The density and diversity of cultured colony forming units (CFUs) between the covered and uncovered machines were compared using Wilcoxon signed-rank test and Student's t -tests. There was a statistically significant reduction in CFU density and diversity when the AMW was employed. The protective effect of the AMW during regular anesthetic care provides a reliable and low-cost method to minimize the transmission of pathogens across patients and potentially reduces HAIs.

  7. 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

  8. 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.

  9. 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

  10. 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 ...

  11. CPUE TRENDS OF THE INDONESIA’S TUNA LONGLINE FISHERY: LESSONS LEARNED FROM A TRIAL OBSERVER PROGRAM

    Directory of Open Access Journals (Sweden)

    Lilis Sadiyah

    2014-06-01

    Full Text Available In an effort to address a shortage of reliable CPUE information, and as a preliminary step to a broader observer program, Indonesia established a Trial Observer Program (TOP for the industrial tuna long line fishery based at Benoa Fishing Port, Bali, in mid 2005. The objectives of this paper are i to describe spatial and temporal catch and effort trends from the Indonesian Indian Ocean industrial tuna long line fishery based at Benoa Fishing Port, and ii to provide an understanding of the fishing strategies used by different companies and of the environmental conditions that may influence catch trends. The observed effort covered areas both north and south of 20°S, with a concentration within 10°-20°S; 105°-120°E which overlaps with the only known spawning grounds of southern bluefin tuna (SBT. This data set showed that SBT comprised the lowest catch proportion, relative to the other three tuna species caught, bigeye tuna (BET, yellowfin tuna (YFT and albacore (ALB. BET and ALB had been suggested as the main target species for the fishery, but this varied by region. The TOP data set suggests that different tuna fishing companies targeted different species and used different fishing practices, including differences in bait used, areas fished, start time of setting, and the number of hooks between floats (HBF. It is a priority to improve the spatial and temporal coverage of the observer program before the data can be considered to be representative of the fleet, particularly given the high degree of variability in fishing practices between companies.

  12. Efficiency and safety of leflunomide in rheumatoid arthritis: Results of a Russian observational multicenter of trial

    Directory of Open Access Journals (Sweden)

    R. M. Balabanova

    2015-01-01

    CRP from 27.8 to 12.35 mg/l. By 6 months of therapy, low and moderate RA activities estimated by DAS28 were noted in 70.9% of cases and those by CDAI in 61.2%. No serious ARs were detected during the study.Conclusion. The findings suggest that leflunomide shows a good clinical efficacy and tolerability.

  13. 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......: 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....... 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...

  14. Application of Cherenkov light observation to reactor measurements (2). Design and trial fabrication of Cherenkov light estimation system

    International Nuclear Information System (INIS)

    Yamamoto, Keiichi; Takeuchi, Tomoaki; Tsuchiya, Kunihiko; Hayashi, Takayasu; Kosuge, Fumiaki; Sano, Tadafumi

    2015-11-01

    Development of the reactor measurement system was started to obtain the real-time in-core nuclear and thermal information, where the quantitative measurement of brightness of Cherenkov light was investigated. This report summarized the results of design and trial fabrication of the Cherenkov light estimation system from thermal power evaluation from Cherenkov light image emitted from the fuel elements. The developed Cherenkov light estimation system was verified with the Cherenkov light image emitted from the fuels in the core of Kyoto University Research Reactor (KUR). From the results, the thermal power of the fuel elements evaluated from the brightness of the Cherenkov light observed by a CCD camera was almost the same as that of thermal power calculated from SRAC code. On the other hand, the evaluation values of some fuel elements were different from the calculation values. This, it is necessary to improve the observation method of Cherenkov light in the reactor and the evaluation method of the brightness of Cherenkov light. (author)

  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 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.......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...

  16. Case-control Studies on the Effectiveness of Breast Cancer Screening: Insights from the UK Age Trial.

    Science.gov (United States)

    van der Waal, Daniëlle; Broeders, Mireille J M; Verbeek, André L M; Duffy, Stephen W; Moss, Sue M

    2015-07-01

    Ongoing breast cancer screening programs can only be evaluated using observational study designs. Most studies have observed a reduction in breast cancer mortality, but design differences appear to have resulted in different estimates. Direct comparison of case-control and trial analyses gives more insight into this variation. Here, we performed case-control analyses within the randomized UK Age Trial. The Age Trial assessed the effect of screening on breast cancer mortality in women ages 40-49 years. In our approach, case subjects were defined as breast cancer deaths between trial entry (1991-1997) and 2004. Women were ages 39-41 years at entry. For every case subject, five control subjects were selected. All case subjects were included in analyses of screening invitation (356 case subjects, 1,780 controls), whereas analyses of attendance were restricted to women invited to screening (105 case subjects, 525 age-matched controls). Odds ratios (OR) were estimated with conditional logistic regression. We used and compared two methods to correct for self-selection bias. Screening invitation resulted in a breast cancer mortality reduction of 17% (95% confidence interval [CI]: -36%, +6%), similar to trial results. Different exposure definitions and self-selection adjustments influenced the observed breast cancer mortality reduction. Depending on the method, "ever screened" appeared to be associated with a small reduction (OR: 0.86, 95% CI: 0.40, 1.89) or no reduction (OR: 1.02, 95% CI: 0.48, 2.14) using the two methods of correction. Recent attendance resulted in an adjusted mortality reduction of 36% (95% CI: -69%, +31%) or 45% (95% CI: -71%, +5%). Observational studies, and particularly case-control studies, are an important monitoring tool for breast cancer screening programs. The focus should be on diminishing bias in observational studies and gaining a better understanding of the influence of study design on estimates of mortality reduction.

  17. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT: study protocol and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kruger Peter

    2011-03-01

    Full Text Available Abstract Background Swine origin influenza A/H1N1 infection (H1N1 emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM, waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to

  18. 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. ...

  19. Clinical Trials

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    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 ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  2. 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, ...

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

    Science.gov (United States)

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

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

  4. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  5. 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

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

    Science.gov (United States)

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    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. 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. 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 activity promotion in families. It should advance our

  7. JAKE® Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder.

    Science.gov (United States)

    Ness, Seth L; Manyakov, Nikolay V; Bangerter, Abigail; Lewin, David; Jagannatha, Shyla; Boice, Matthew; Skalkin, Andrew; Dawson, Geraldine; Janvier, Yvette M; Goodwin, Matthew S; Hendren, Robert; Leventhal, Bennett; Shic, Frederick; Cioccia, Walter; Pandina, Gahan

    2017-01-01

    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.

  8. 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

  9. 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

  10. Space observations for global and regional studies of the biosphere

    Science.gov (United States)

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

    1994-01-01

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

  11. 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.

  12. 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.

  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. [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.

  15. Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process.

    Science.gov (United States)

    Nestle, Ursula; Rischke, Hans Christian; Eschmann, Susanne Martina; Holl, Gabriele; Tosch, Marco; Miederer, Matthias; Plotkin, Michail; Essler, Markus; Puskas, Cornelia; Schimek-Jasch, Tanja; Duncker-Rohr, Viola; Rühl, Friederike; Leifert, Anja; Mix, Michael; Grosu, Anca-Ligia; König, Jochem; Vach, Werner

    2015-11-01

    Oncologic imaging is a key for successful cancer treatment. While the quality assurance (QA) of image acquisition protocols has already been focussed, QA of reading and reporting offers still room for improvement. The latter was addressed in the context of a prospective multicentre trial on fluoro-deoxyglucose (FDG)-positron-emission tomography (PET)/CT-based chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). An expert panel was prospectively installed performing blinded reviews of mediastinal NSCLC involvement in FDG-PET/CT. Due to a high initial reporting inter-observer disagreement, the independent data monitoring committee (IDMC) triggered an interventional harmonisation process, which overall involved 11 experts uttering 6855 blinded diagnostic statements. After assessing the baseline inter-observer agreement (IOA) of a blinded re-review (phase 1), a discussion process led to improved reading criteria (phase 2). Those underwent a validation study (phase 3) and were then implemented into the study routine. After 2 months (phase 4) and 1 year (phase 5), the IOA was reassessed. The initial overall IOA was moderate (kappa 0.52 CT; 0.53 PET). After improvement of reading criteria, the kappa values improved substantially (kappa 0.61 CT; 0.66 PET), which was retained until the late reassessment (kappa 0.71 CT; 0.67 PET). Subjective uncertainty was highly predictive for low IOA. The IOA of an expert panel was significantly improved by a structured interventional harmonisation process which could be a model for future clinical trials. Furthermore, the low IOA in reporting nodal involvement in NSCLC may bear consequences for individual patient care. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. 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

    2018-06-01

    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.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  18. POLICY IMPLICATIONS OF ADJUSTING RANDOMIZED TRIAL DATA FOR ECONOMIC EVALUATIONS: A DEMONSTRATION FROM THE ASCUS-LSIL TRIAGE STUDY

    Science.gov (United States)

    Campos, Nicole G.; Castle, Philip E.; Schiffman, Mark; Kim, Jane J.

    2013-01-01

    Background Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Methods Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm, and 2) potential ascertainment bias among providers in the most aggressive management arm. Results We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for two of the three age groups we considered. Conclusion Decision analysts need to examine study design, available trial data and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data. PMID:22147881

  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. Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial

    Science.gov (United States)

    García-Sanz, Ramón; Oriol, Albert; Moreno, María J.; de la Rubia, Javier; Payer, Angel R.; Hernández, Miguel T.; Palomera, Luis; Teruel, Ana I.; Blanchard, María J.; Gironella, Mercedes; Ribas, Paz; Bargay, Joan; Abellá, Eugenia; Granell, Miquel; Ocio, Enrique M.; Ribera, Josep M.; San Miguel, Jesús F.; Mateos, María V.

    2015-01-01

    This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse. One hundred patients were randomized to receive either zoledronic acid (4 mg iv/4 weeks, 12 doses) (n=51) or not (n=49). Experimental and control groups were well balanced for disease and prognostic features. Zoledronic acid did not show an antitumor effect according to changes in M-component. However, there were fewer symptomatic progressions in the experimental group than in the control group (34 versus 41, respectively; P=0.05) resulting in a median time to symptoms of 16 versus 10 months (P=0.161). The median time to next therapy was also slightly longer for the treated group than the untreated, control group (13.4 versus 10.1 months), although the difference was not statistically significant (P=0.360). The pattern of relapses was different for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunction (1 versus 2), and plasmacytomas (1 versus 1, respectively). This concurred with fewer skeletal-related events in the treated group than in the control group (2 versus 14), with a projected 4-year event proportion of 6% versus 40% (P<0.001). In summary, zoledronic acid monotherapy does not show an antitumor effect on biochemical relapses in multiple myeloma, but does reduce the risk of progression with symptomatic bone disease and skeletal complications. This trial was registered in the ClinicalTrials.gov database with code NCT01087008 PMID:26069291

  1. 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

  2. Observed Orbit Effects during Long Range Beam-Beam Studies

    CERN Document Server

    Alemany, R; Buffat, X; Calaga, R; Fitterer, M; Giachino, R; Hemelsoet, GH; Herr, W; Papotti, G; Pieloni, T; Poyer, M; Schaumann, M; Trad, G; Wollmann, D

    2012-01-01

    Possible limitations due to long range beam-beam effects at the LHC have been studied and are presented in this note. With a larger number of bunches and collisions in all interaction points, the crossing angles were reduced to enhance long range beam-beam effects. The analysis of the effects on the dynamic aperture and losses are documented in [1]. This note concentrates on the bunch-by-bunch orbit effects observed during the experiment.

  3. 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.

  4. The new worlds observer: The astrophysics strategic mission concept study

    Directory of Open Access Journals (Sweden)

    Cash W.

    2011-07-01

    Full Text Available We present some results of the Astrophysics Strategic Mission Concept Study for the New Worlds Observer (NWO. We show that the use of starshades is the most effective and affordable path to mapping and understanding our neighboring planetary systems, to opening the search for life outside our solar system, while serving the needs of the greater astronomy community. A starshade-based mission can be implemented immediately with a near term program of technology demonstration.

  5. Integrating technology into complex intervention trial processes: a case study.

    Science.gov (United States)

    Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

    2016-11-17

    Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

  6. A foundational observation method for studying design situations

    DEFF Research Database (Denmark)

    Cash, Philip; Hicks, Ben; Culley, Steve

    2015-01-01

    Observational studies of designers play an important role in engineering design research, yet there is currently no accepted standard approach for comparing, combining, or contrasting studies. Consequentially, reuse, reanalysis, replication, and aggregation of data are limited and the potential...... 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...

  7. 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

  8. 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

  9. 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.

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

    Science.gov (United States)

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

    2014-10-01

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

  12. 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.

  13. Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bucur, Roxana C; Reid, Lauren S; Hamilton, Celeste J; Cummings, Steven R; Jamal, Sophie A

    2013-09-08

    Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. This will be an open-label randomized, controlled trial conducted at Women's College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We will use the 'multiple

  14. 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

  15. Effect of parent-delivered action observation therapy on upper limb function in unilateral cerebral palsy: a randomized controlled trial.

    Science.gov (United States)

    Kirkpatrick, Emma; Pearse, Janice; James, Peter; Basu, Anna

    2016-10-01

    To determine whether home-based, parent-delivered therapy comprising action observation (AO) and repeated practice (RP) improves upper limb function more than RP alone in children with unilateral cerebral palsy (UCP). single-blinded parallel-group randomized controlled trial with 1:1 allocation comparing AO+RP (intervention) with RP alone (control). computer-generated, with allocation concealment by opaque sequentially-numbered envelopes. northern England, August 2011 to September 2013. 70 children with UCP; mean age 5.6 years (SD 2.1), 31 female. home-based activities were provided, tailored to interests and abilities. 15 minutes/day, 5 days/week for 3 months. Assisting Hand Assessment (AHA; primary outcome measure), Melbourne Assessment 2 (MA2), and ABILHAND-Kids at baseline, 3 months, and 6 months. Outcome data was available at 3 months for 28 children in the AO+RP group and 31 controls, and at 6 months for 26 and 28 children respectively. There were no between-group differences in AHA, MA2, or ABILHAND-Kids at 3 or 6 months versus baseline (all p>0.05). Combined-group improvements (pMA2 at 3 months, were maintained at 6 months. ABILHAND-Kids also showed improvement at 3 months (p=0.003), maintained at 6 months. Parent-delivered RP (with or without AO) improves upper limb function and could supplement therapist input. © 2016 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.

  16. Antibiotic prescription strategies for acute sore throat: a prospective observational cohort study.

    Science.gov (United States)

    Little, Paul; Stuart, Beth; Hobbs, F D Richard; Butler, Chris C; Hay, Alastair D; Delaney, Brendan; Campbell, John; Broomfield, Sue; Barratt, Paula; Hood, Kerenza; Everitt, Hazel; Mullee, Mark; Williamson, Ian; Mant, David; Moore, Michael

    2014-03-01

    Data from trials suggest that antibiotics reduce the risk of complications of sore throat by at least 50%, but few trials for complications have been done in modern settings, and datasets of delayed antibiotic prescription are underpowered. Observational evidence is important in view of poor compliance with antibiotic treatment outside trials, but no prospective observational cohort studies have been done to date. We generated a large prospective cohort from the DESCARTE study, and the PRISM component of DESCARTE, of 12,829 adults presenting with sore throat (≤ 2 weeks duration) in primary care. Our follow-up of the cohort was based on a detailed and structured review of routine medical records, and analysis of the comparison of three antibiotic prescription strategies (no antibiotic prescription, immediate antibiotic prescription, and delayed antibiotic prescription) to control for the propensity to prescribe antibiotics. Information about antibiotic prescription was recorded in 12,677 individuals (4805 prescribed no antibiotics, 6088 prescribed antibiotics immediately, and 1784 prescribed delayed antibiotics). We documented by review of patients' notes (n=11,950) the development of suppurative complications (eg, quinsy, impetigo and cellulitis, otitis media, and sinusitis) or reconsultation with new or non-resolving symptoms). We used multivariate analysis to control for variables significantly related to the propensity to prescribe antibiotics and for clustering by general practitioner. 164 (1.4%) of the 11,950 patients with information available developed complications; otitis media and sinusitis were the most common complications (101 patients [62%]). Compared with no antibiotic prescription, immediate antibiotic prescription was associated with fewer complications (adjusted risk ratio [RR] 0.62, 95% CI 0.43-0.91, estimated number needed to treat [NNT 193) as was delayed prescription of antibiotics (0.58, 0.34-0.98; NNT 174). 1787 of the 11,950 patients (15

  17. 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…

  18. 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...

  19. 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....

  20. The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

    Directory of Open Access Journals (Sweden)

    Nakkash Rima

    2011-08-01

    Full Text Available Abstract Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks. Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress. Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241

  1. 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

  2. An observational study of sea breeze characteristics over Kalpakkam Coast

    International Nuclear Information System (INIS)

    Mohan, Manju; Mishra, M.K.

    2005-01-01

    An observational study of the sea breeze characteristics has been carried out at Kalpakkam, India which lies on the East coast of Southern Indian peninsula about 700 m inland from the sea, the Bay of Bengal. There are clear and significant changes in the surface meteorological parameters at the onset and during sea-breeze phenomenon in the coastal areas. Hourly averaged measurements from a 30 m tall micrometeorological tower were used to study the sea-breeze characteristics at the above site. In this study, based on detailed analysis of the data on-set criteria of the sea breeze is characterized by increase in relative humidity at least by 5%, fall in temperature by equal or greater than 0.5 K and increase in wind speed with respect to previous hour record. The present study is also compared with the earlier studies in relation to sea breeze carried out at Chennai located approximately 80 km North from Kalpakkam and the differences between these studies are discussed. The comparison of sea breeze characteristics of the present study with those from earlier studies that were carried out more than half a century back also reflects the changes due to urbanization and other development activities as well as resulting climatic impacts. (author)

  3. 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

  4. 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.

  5. 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.

  6. 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.

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

    Science.gov (United States)

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

    2016-03-30

    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. 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. 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. 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.

  8. An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

    Science.gov (United States)

    Brass, D; Fouweather, T; Stocken, D D; Macdonald, C; Wilkinson, J; Lloyd, J; Farr, P M; Reynolds, N J; Hampton, P J

    2017-12-13

    Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective. To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids. Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI). In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups. In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema. © 2017 British Association of Dermatologists.

  9. Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol.

    Science.gov (United States)

    Thamsborg, Lise Holst; Andersen, Berit; Larsen, Lise Grupe; Christensen, Jette; Johansen, Tonje; Hariri, Jalil; Christiansen, Sanne; Rygaard, Carsten; Lynge, Elsebeth

    2018-05-26

    The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls. Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7-8 years. The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data. The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal. NCT03049553; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. 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...... records. Sixty-eight women (5.8%) developed GDM. Serum YKL-40 increased from gestational age (GA) 12 weeks and the following weeks in the women who developed GDM and was independent of BMI, parity, and maternal age (OR = 2.69, 95% CI: 1.45-5.00, p = 0.002). No association was found between serum YKL-40...

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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 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.

  16. 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.

  17. JAKE® Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder

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    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.

  18. 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

  19. Prospective Observational Study on acute Appendicitis Worldwide (POSAW).

    Science.gov (United States)

    Sartelli, Massimo; Baiocchi, Gian L; Di Saverio, Salomone; Ferrara, Francesco; Labricciosa, Francesco M; Ansaloni, Luca; Coccolini, Federico; Vijayan, Deepak; Abbas, Ashraf; Abongwa, Hariscine K; Agboola, John; Ahmed, Adamu; Akhmeteli, Lali; Akkapulu, Nezih; Akkucuk, Seckin; Altintoprak, Fatih; Andreiev, Aurelia L; Anyfantakis, Dimitrios; Atanasov, Boiko; Bala, Miklosh; Balalis, Dimitrios; Baraket, Oussama; Bellanova, Giovanni; Beltran, Marcelo; Melo, Renato Bessa; Bini, Roberto; Bouliaris, Konstantinos; Brunelli, Daniele; Castillo, Adrian; Catani, Marco; Che Jusoh, Asri; Chichom-Mefire, Alain; Cocorullo, Gianfranco; Coimbra, Raul; Colak, Elif; Costa, Silvia; Das, Koray; Delibegovic, Samir; Demetrashvili, Zaza; Di Carlo, Isidoro; Kiseleva, Nadezda; El Zalabany, Tamer; Faro, Mario; Ferreira, Margarida; Fraga, Gustavo P; Gachabayov, Mahir; Ghnnam, Wagih M; Giménez Maurel, Teresa; Gkiokas, Georgios; Gomes, Carlos A; Griffiths, Ewen; Guner, Ali; Gupta, Sanjay; Hecker, Andreas; Hirano, Elcio S; Hodonou, Adrien; Hutan, Martin; Ioannidis, Orestis; Isik, Arda; Ivakhov, Georgy; Jain, Sumita; Jokubauskas, Mantas; Karamarkovic, Aleksandar; Kauhanen, Saila; Kaushik, Robin; Kavalakat, Alfie; Kenig, Jakub; Khokha, Vladimir; Khor, Desmond; Kim, Dennis; Kim, Jae I; Kong, Victor; Lasithiotakis, Konstantinos; Leão, Pedro; Leon, Miguel; Litvin, Andrey; Lohsiriwat, Varut; López-Tomassetti Fernandez, Eudaldo; Lostoridis, Eftychios; Maciel, James; Major, Piotr; Dimova, Ana; Manatakis, Dimitrios; Marinis, Athanasio; Martinez-Perez, Aleix; Marwah, Sanjay; McFarlane, Michael; Mesina, Cristian; Pędziwiatr, Michał; Michalopoulos, Nickos; Misiakos, Evangelos; Mohamedahmed, Ali; Moldovanu, Radu; Montori, Giulia; Mysore Narayana, Raghuveer; Negoi, Ionut; Nikolopoulos, Ioannis; Novelli, Giuseppe; Novikovs, Viktors; Olaoye, Iyiade; Omari, Abdelkarim; Ordoñez, Carlos A; Ouadii, Mouaqit; Ozkan, Zeynep; Pal, Ajay; Palini, Gian M; Partecke, Lars I; Pata, Francesco; Pędziwiatr, Michał; Pereira Júnior, Gerson A; Pintar, Tadeja; Pisarska, Magdalena; Ploneda-Valencia, Cesar F; Pouggouras, Konstantinos; Prabhu, Vinod; Ramakrishnapillai, Padmakumar; Regimbeau, Jean-Marc; Reitz, Marianne; Rios-Cruz, Daniel; Saar, Sten; Sakakushev, Boris; Seretis, Charalampos; Sazhin, Alexander; Shelat, Vishal; Skrovina, Matej; Smirnov, Dmitry; Spyropoulos, Charalampos; Strzałka, Marcin; Talving, Peep; Teixeira Gonsaga, Ricardo A; Theobald, George; Tomadze, Gia; Torba, Myftar; Tranà, Cristian; Ulrych, Jan; Uzunoğlu, Mustafa Y; Vasilescu, Alin; Occhionorelli, Savino; Venara, Aurélien; Vereczkei, Andras; Vettoretto, Nereo; Vlad, Nutu; Walędziak, Maciej; Yilmaz, Tonguç U; Yuan, Kuo-Ching; Yunfeng, Cui; Zilinskas, Justas; Grelpois, Gérard; Catena, Fausto

    2018-01-01

    Acute appendicitis (AA) is the most common surgical disease, and appendectomy is the treatment of choice in the majority of cases. A correct diagnosis is key for decreasing the negative appendectomy rate. The management can become difficult in case of complicated appendicitis. The aim of this study is to describe the worldwide clinical and diagnostic work-up and management of AA in surgical departments. This prospective multicenter observational study was performed in 116 worldwide surgical departments from 44 countries over a 6-month period (April 1, 2016-September 30, 2016). All consecutive patients admitted to surgical departments with a clinical diagnosis of AA were included in the study. A total of 4282 patients were enrolled in the POSAW study, 1928 (45%) women and 2354 (55%) men, with a median age of 29 years. Nine hundred and seven (21.2%) patients underwent an abdominal CT scan, 1856 (43.3%) patients an US, and 285 (6.7%) patients both CT scan and US. A total of 4097 (95.7%) patients underwent surgery; 1809 (42.2%) underwent open appendectomy and 2215 (51.7%) had laparoscopic appendectomy. One hundred eighty-five (4.3%) patients were managed conservatively. Major complications occurred in 199 patients (4.6%). The overall mortality rate was 0.28%. The results of the present study confirm the clinical value of imaging techniques and prognostic scores. Appendectomy remains the most effective treatment of acute appendicitis. Mortality rate is low.

  20. Periodontal disease and risk of preeclampsia: a meta-analysis of observational studies.

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    Ben-Juan Wei

    Full Text Available BACKGROUND: Many epidemiological studies have found a positive association between periodontal disease (PD and the risk of preeclampsia, but the magnitude of this association varies and independent studies have reported conflicting findings. We performed a meta-analysis to ascertain the relationship between PD and preeclampsia. METHODS: The PubMed database was searched up to January 12, 2013, for relevant observational studies on an association between PD and the risk of preeclampsia. Data were extracted and analyzed independently by two authors. The meta-analysis was performed using comprehensive meta-analysis software. RESULTS: Thirteen observational case-control studies and two cohort studies, involving 1089 preeclampsia patients, were identified. Based on a random-effects meta-analysis, a significant association between PD and preeclampsia was identified (odds ratio = 2.79, 95% confidence interval CI, 2.01-3.01, P<0.0001. CONCLUSIONS: Although the causality remains unclear, the association between PD and preeclampsia may reflect the induction of PD by the preeclamptic state, or it may be part of an overall exaggerated inflammatory response to pregnancy. Larger randomized controlled trials with preeclampsia as the primary outcome and pathophysiological studies are required to explore causality and to dissect the biological mechanisms involved.

  1. 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

  2. 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

  3. 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

  4. Conducting feasibilities in clinical trials: An investment to ensure a good study

    Directory of Open Access Journals (Sweden)

    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.

  5. Conducting feasibilities in clinical trials: an investment to ensure a good study.

    Science.gov (United States)

    Rajadhyaksha, Viraj

    2010-07-01

    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.

  6. Learning crisis resource management: Practicing versus an observational role in simulation training - a randomized controlled trial.

    Science.gov (United States)

    Lai, Anita; Haligua, Alexis; Dylan Bould, M; Everett, Tobias; Gale, Mark; Pigford, Ashlee-Ann; Boet, Sylvain

    2016-08-01

    Simulation training has been shown to be an effective way to teach crisis resource management (CRM) skills. Deliberate practice theory states that learners need to actively practice so that learning is effective. However, many residency programs have limited opportunities for learners to be "active" participants in simulation exercises. This study compares the effectiveness of learning CRM skills when being an active participant versus being an observer participant in simulation followed by a debriefing. Participants were randomized to two groups: active or observer. Active participants managed a simulated crisis scenario (pre-test) while paired observer participants viewed the scenario via video transmission. Then, a trained instructor debriefed participants on CRM principles. On the same day, each participant individually managed another simulated crisis scenario (post-test) and completed a post-test questionnaire. Two independent, blinded raters evaluated all videos using the Ottawa Global Rating Scale (GRS). Thirty-nine residents were included in the analysis. Normally distributed data were analyzed using paired and unpaired t-tests. Inter-rater reliability was 0.64. Active participants significantly improved from pre-test to post-test (P=0.015). There was no significant difference between the post-test performance of active participants compared to observer participants (P=0.12). We found that learning CRM principles was not superior when learners were active participants compared to being observers followed by debriefing. These findings challenge the deliberate practice theory claiming that learning requires active practice. Assigning residents as observers in simulation training and involving them in debriefing is still beneficial. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  7. 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.

  8. 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.

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

    Science.gov (United States)

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

    2013-03-01

    Breakthrough pain (BTP) is traditionally defined as a transitory pain flare in opioid-treated patients with chronic background pain. This definition has, however, been challenged in recent years. This study aimed to analyze BTP prevalence in different pain conditions. This was a prospective, non-interventional, observational study conducted from June to September 2011 in two Italian pain treatment reference centres. Consecutive patients aged >18 years with oncological or non-oncological pain were eligible for this study; background pain was acute/ subacute (3 months). The characteristics of pain were evaluated by means of a structured interview by physicians, and patients were asked to complete a dedicated clinical study form. The following outcomes were assessed: chronic pain duration (in patients with chronic pain), BTP prevalence, and number and severity of daily BTP episodes. All outcomes were assessed in four populations of patients with: (a) chronic oncological pain; (b) chronic non-oncological pain; (c) non-chronic oncological pain; (d) non-chronic non-oncological pain. The correlation between BTP and gender was also investigated. Of 1,270 patients with chronic pain, 1,086 had non-oncological pain (85.5%). Most patients (68.6%) with non-oncological pain were female (P = 0.001). Pain duration was significantly longer in non-oncological pain versus oncological pain groups (P = 0.002). BTP prevalence was lower in non-oncological patients (P definition. BTP frequency and severity is similar in oncological and non-oncological pain.

  10. Warfarin and fibrinolysis - a challenging combination: an observational cohort study

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    Luurila Harri

    2011-04-01

    Full Text Available Abstract Background Patients presenting with ST-segment elevation myocardial infarction (STEMI frequently use warfarin. Fibrinolytic agents and warfarin both increase bleeding risk, but only a few studies have been published concerning the bleeding risk of warfarin-prescribed patients receiving fibrinolysis. The objective of this study was to define the prevalence for intracranial haemorrhage (ICH or major bleeding in patients on warfarin treatment receiving pre-hospital fibrinolysis. Methods This was an observational cohort study. Data for this retrospective case series were collected in Helsinki Emergency Medical Service catchment area from 1.1.1997 to 30.6.2010. All warfarin patients with suspected ST-segment elevation myocardial infarction (STEMI, who received pre-hospital fibrinolysis, were included. Bleeding complications were detected from Medical Records and classified as ICH, major or minor bleeding. Results Thirty-six warfarin patients received fibrinolysis during the study period. Fourteen patients had bleeding complications. One (3%, 95% CI 0-15% patient had ICH, six (17%, 95% CI 7-32% had major and seven (19%, 95% CI 9-35% had minor bleeding. The only fatal bleeding occurred in a patient with ICH. Patients' age, fibrinolytic agent used or aspirin use did not predispose to bleeding complications. High International Normalized Ratio (INR seemed to predispose to bleedings with values over 3, but no statistically significant difference was found. Conclusions Bleedings occur frequently in warfarin patients treated with fibrinolysis in the real world setting, but they are rarely fatal.

  11. An observational study of foot lifts asymmetry during obstacle avoidance

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    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.

  12. Intrauterine temperature during intrapartum amnioinfusion: a prospective observational study.

    Science.gov (United States)

    Tomlinson, T M; Schaecher, C; Sadovsky, Y; Gross, G

    2012-07-01

    To determine the influence of routine intrapartum amnioinfusion (AI) on intrauterine temperature. Prospective observational study. Maternity unit, Barnes Jewish Hospital, St Louis, MO, USA. Forty women with singleton gestations and an indication for intrapartum intrauterine pressure catheter placement. Using a temperature probe, we digitally recorded intrauterine temperature every 10 minutes during labour. Amnioinfusion was administered according to a standard protocol using saline equilibrated to the ambient temperature. Mean intrauterine temperature during labour. Participants were monitored for a mean of 280 minutes (range 20-820). A total of 164 intrauterine temperature readings in the AI cohort were compared with 797 control measurements. When compared with controls, we observed a lower intrauterine temperature in the AI cohort (36.4 versus 37.4°C, P<0.01). More measurements in the AI cohort were recorded in the presence of intrapartum fever (40% versus 30%). A subgroup analysis of measurements recorded in afebrile parturients revealed an even greater effect of AI (1.5°C decrease, 37.3 versus 35.8°C, P<0.01). Routine intrapartum AI using saline equilibrated to a mean ambient temperature of 25.0°C reduces intrauterine temperature and may thereby affect fetal core temperature. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  13. 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

  14. "I will miss the study, God bless you all": participation in a nutritional chemoprevention trial.

    Science.gov (United States)

    Moreno-Black, Geraldine; Shor-Posner, Gail; Miguez, Maria-Jose; Burbano, Ximena; O'Mellan, Sandra; Yovanoff, P

    2004-01-01

    Randomized controlled clinical trials are often considered to be the "gold standard" for health research. Consequently, understanding the reasons people participate in these trials, especially minority groups who are often under-represented in clinical trials, or populations who have chronic illnesses or abuse drugs, is salient for successful recruitment, retention, and project design. This paper describes the results of a study that was designed to examine some of the ways in which participants in a randomized double blind clinical trial perceived their participation in the clinical trial, and the reasons they gave for continuing in the study. All of the participants were individuals who were using drugs and were infected with the HIV-1 virus, and had participated in a chemoprevention trial. The data from an exit interview were analyzed thematically in order to reveal units of meaning concerning participation and continuation in the clinical trial. The analysis revealed 3 higher-level concepts, or themes, that guided participation: increased health awareness, personal enhancement, and sociability. The data clearly indicated that involvement and retention in the trial were directly related to the ways in which the participants interpreted the study, perceived the benefits they derived from participating, and imbued their participation with value so that it was important and relevant to their own perceptions of health, as well as personal and social well being.

  15. [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.

  16. 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.

  17. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. Reporting outcomes of back pain trials: a modified Delphi study

    DEFF Research Database (Denmark)

    Froud, R.; Eldridge, S.; Kovacs, F.

    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......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

  5. Radiology workstation for mammography: preliminary observations, eyetracker studies, and design

    Science.gov (United States)

    Beard, David V.; Johnston, Richard E.; Pisano, Etta D.; Hemminger, Bradley M.; Pizer, Stephen M.

    1991-07-01

    For the last four years, the UNC FilmPlane project has focused on constructing a radiology workstation facilitating CT interpretations equivalent to those with film and viewbox. Interpretation of multiple CT studies was originally chosen because handling such large numbers of images was considered to be one of the most difficult tasks that could be performed with a workstation. The authors extend the FilmPlane design to address mammography. The high resolution and contrast demands coupled with the number of images often cross- compared make mammography a difficult challenge for the workstation designer. This paper presents the results of preliminary work with workstation interpretation of mammography. Background material is presented to justify why the authors believe electronic mammographic workstations could improve health care delivery. The results of several observation sessions and a preliminary eyetracker study of multiple-study mammography interpretations are described. Finally, tentative conclusions of what a mammographic workstation might look like and how it would meet clinical demand to be effective are presented.

  6. Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

    Science.gov (United States)

    Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

    2018-01-01

    Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

  7. 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

  8. 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.)

  9. 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.

  10. [Association between chronic periodontitis and hyperlipidemia: a Meta-analysis based on observational studies].

    Science.gov (United States)

    Lianhui, Yang; Meifei, Lian; Zhongyue, Hu; Yunzhi, Feng

    2017-08-01

    Objective The aim of this study is to evaluate the relationship between periodontitis and hyperlipidemia risks through Meta-analysis. Methods Two researchers conducted an electronic search on PubMed, Cochrane Library, Embase, CBM, CNKI, Wanfang and VIP databases established until July 2016 for observational studies on the association between periodontitis and hyperlipidemia. The language used was limited to Chinese and English. After data extraction and quality evaluation of included trials, Meta-analysis was conducted using the RevMan 5.3 software. The GRADE 3.6 software was used to evaluate the quality level of the evidence. Results Six case-control studies and one cohort study were included. The results of Meta-analysis showed that serum triglyceride (TG) in patients with periodontitis was significantly higher than that of the periodontal health group (MD=50.50, 95% confidence interval=39.57-61.42, Pchronic periodontitis were 4.73 times (OR=4.73, 95% confidence interval=2.74-8.17, Pperiodontal healthy patients. No significant difference was observed between the group with high-density lipoprotein cholesterol (HDL-C) and that with low density lipoprotein cholesterol (LDL-C). Conclusion Current evidence indicates that a correlation exists between chronic periodontitis and hyperlipidemia, and chronic periodontitis is an independent risk factor for hyperlipidemia, especially for TC and TG in serum.

  11. Clinical Trials

    Medline Plus

    Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  14. Validation of the Diabetes Prevention Trial-Type 1 Risk Score in the TrialNet Natural History Study.

    Science.gov (United States)

    Sosenko, Jay M; Skyler, Jay S; Mahon, Jeffrey; Krischer, Jeffrey P; Beam, Craig A; Boulware, David C; Greenbaum, Carla J; Rafkin, Lisa E; Cowie, Catherine; Cuthbertson, David; Palmer, Jerry P

    2011-08-01

    We assessed the accuracy of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS), developed from the Diabetes Prevention Trial-Type 1 (DPT-1), in the TrialNet Natural History Study (TNNHS). Prediction accuracy of the DPTRS was assessed with receiver-operating characteristic curve areas. The type 1 diabetes cumulative incidence within the DPTRS intervals was compared between the TNNHS and DPT-1 cohorts. Receiver-operating characteristic curve areas for the DPTRS were substantial in the TNNHS (P < 0.001 at both 2 and 3 years). The type 1 diabetes cumulative incidence did not differ significantly between the TNNHS and DPT-1 cohorts within DPTRS intervals. In the TNNHS, 2-year and 3-year risks were low for DPTRS intervals <6.50 (<0.10 and <0.20, respectively). Thresholds ≥7.50 were indicative of high risk in both cohorts (2-year risks: 0.49 in the TNNHS and 0.51 in DPT-1). The DPTRS is an accurate and robust predictor of type 1 diabetes in autoantibody-positive populations.

  15. 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

  16. 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.

  17. 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

  18. Observational Study on Safety of Prehospital BLS CPAP in Dyspnea.

    Science.gov (United States)

    Sahu, Novneet; Matthews, Patrick; Groner, Kathryn; Papas, Mia A; Megargel, Ross

    2017-12-01

    Introduction Continuous positive airway pressure (CPAP) improves outcomes in patients with respiratory distress. Additional benefits are seen with CPAP application in the prehospital setting. Theoretical safety concerns regarding Basic Life Support (BLS) providers using CPAP exist. In Delaware's (USA) two-tiered Emergency Medical Service (EMS) system, BLS often arrives before Advanced Life Support (ALS). Hypothesis This study fills a gap in literature by evaluating the safety of CPAP applied by BLS prior to ALS arrival. This was a retrospective, observational study using Quality Assurance (QA) data collected from October 2009 through December 2012 throughout a state BLS CPAP pilot program; CPAP training was provided to BLS providers prior to participation. Collected data include pulse-oximetry (spO2), respiratory rate (RR), heart rate (HR), skin color, and Glasgow Coma Score (GCS) before and after CPAP application. Pre-CPAP and post-CPAP values were compared using McNemar's and t-tests. Advanced practitioners evaluated whether CPAP was correctly applied and monitored and whether the patient condition was "improved," "unchanged," or "worsened." Seventy-four patients received CPAP by BLS; CPAP was correctly indicated and applied for all 74 patients. Respiratory status and CPAP were appropriately monitored and documented in the majority of cases (98.6%). A total of 89.2% of patients improved and 4.1% worsened; CPAP significantly reduced the proportion of patients with SpO224, and cyanosis (PCPAP (mean difference [MD]=0.17; 95% CI, -0.49 to 0.83; P=.59). The HR decreased from 115.7 (SD=53) to 105.1 (SD=37) after CPAP (MD=-10.9; 95% CI, -3.2 to -18.6; PCPAP (MD=17.8; 95% CI, 14.2-21.5; PCPAP was indicated, to apply it correctly, and to appropriately monitor the status of these patients. The majority of patients who received CPAP by BLS providers had improvement in their clinical status and vital signs. The findings suggest that CPAP can be safely used by BLS providers

  19. 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

  20. [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.

  1. 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

  2. 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.

  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. Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Loozen, Charlotte S; van Santvoort, Hjalmar C; van Geloven, Antoinette A W; Nieuwenhuijzen, Grard A P; de Reuver, Philip R; Besselink, Mark H G; Vlaminckx, Bart; Kelder, Johannes C; Knibbe, Catherijne A J; Boerma, Djamila

    2017-08-23

    The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. Evidence-based guidelines are lacking, and consequently the use of antibiotic prophylaxis varies greatly among surgeons and hospitals. Recently, high-level evidence became available demonstrating that postoperative antibiotic prophylaxis in patients with acute cholecystitis does not reduce the risk of infectious complications. Preoperative antibiotic prophylaxis in relation to the risk of infectious complications, however, has never been studied. The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial whose aim is to determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Patients with mild or moderate acute cholecystitis, as defined according the Tokyo Guidelines, will be randomly assigned to a single preoperative dose of antibiotic prophylaxis (2000 mg of first-generation cephalosporin delivered intravenously) or no antibiotic prophylaxis before emergency cholecystectomy. The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery. Secondary endpoints include all the individual components of the primary endpoint, all other complications, duration of hospital stay, and total costs. The hypothesis is that the absence of antibiotic prophylaxis is noninferior to the presence of antibiotic prophylaxis. A noninferiority margin of 10% is assumed. With a 1-sided risk of 2.5% and a power of 80%, a total of 454 subjects will have to be included. Analysis will be performed according to the intention-to-treat principle. The PEANUTS II trial will provide evidence-based advice concerning the utility of antibiotic prophylaxis in patients undergoing

  5. 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

  6. Safe medication management in specialized home healthcare - an observational study.

    Science.gov (United States)

    Lindblad, Marléne; Flink, Maria; Ekstedt, Mirjam

    2017-08-24

    Medication management is a complex, error-prone process. The aim of this study was to explore what constitutes the complexity of the medication management process (MMP) in specialized home healthcare and how healthcare professionals handle this complexity. The study is theoretically based in resilience engineering. Data were collected during the MMP at three specialized home healthcare units in Sweden using two strategies: observation of workplaces and shadowing RNs in everyday work, including interviews. Transcribed material was analysed using grounded theory. The MMP in home healthcare was dynamic and complex with unclear boundaries of responsibilities, inadequate information systems and fluctuating work conditions. Healthcare professionals adapted their everyday clinical work by sharing responsibility and simultaneously being authoritative and preserving patients' active participation, autonomy and integrity. To promote a safe MMP, healthcare professionals constantly re-prioritized goals, handled gaps in communication and information transmission at a distance by creating new bridging solutions. Trade-offs and workarounds were necessary elements, but also posed a threat to patient safety, as these interim solutions were not systematically evaluated or devised learning strategies. To manage a safe medication process in home healthcare, healthcare professionals need to adapt to fluctuating conditions and create bridging strategies through multiple parallel activities distributed over time, space and actors. The healthcare professionals' strategies could be integrated in continuous learning, while preserving boundaries of safety, instead of being more or less interim solutions. Patients' and family caregivers' as active partners in the MMP may be an underestimated resource for a resilient home healthcare.

  7. 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.

  8. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study: Rationale and Trial Protocol.

    Science.gov (United States)

    Toyoda, Kazunori; Minematsu, Kazuo; Yasaka, Masahiro; Nagai, Yoji; Hosomi, Naohisa; Origasa, Hideki; Kitagawa, Kazuo; Uchiyama, Shinichiro; Koga, Masatoshi; Matsumoto, Masayasu

    2017-03-01

    The preventive effect of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) on progression of carotid intima-media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. The Japan Statin Treatment Against Recurrent Stroke (J-STARS) Echo Study aims to determine the effect of pravastatin on carotid IMT in Japanese patients with hyperlipidemia who developed noncardioembolic ischemic stroke. This is a substudy of the J-STARS, a multicenter, randomized, open-label, blinded-end point, parallel-group trial to examine whether pravastatin reduces stroke recurrence in patients with noncardioembolic stroke. The patients are randomized to receive pravastatin (10 mg daily) or not to receive any statins. Carotid ultrasonography is performed by well-trained certified examiners in each participating institute, and the recorded data are measured centrally. The primary outcome is change in the IMT of the distal wall in a consecutive 2-cm section on the central side of the common carotid artery bifurcation over 5 years of observation. The trial may help determine if the usual dose of pravastatin for daily clinical practice in Japan can affect carotid IMT in Japanese patients with noncardioembolic stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  9. 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 women are randomly assigned to 'standard high risk care' or 'standard high risk care' plus enoxaparin 40 mg from recruitment until 36 +0 weeks or delivery, whichever occurs sooner. Standard high risk care includes the use of aspirin 100 mg daily and calcium 1000-1500 mg daily (unless only had previous SGA with no preeclampsia). The primary outcome is preeclampsia and/or SGA restricted composite primary outcome. The inclusion of standard use of aspirin (and calcium) for all participants will help to ensure that any differences observed in outcome are likely to be related to enoxaparin use. These data will make a significant contribution to future meta-analyses and systematic reviews on the use of LMWH for the prevention of placental mediated conditions. ACTRN12609000699268 Australian New Zealand Clinical Trials Registry. Date registered 13/Aug/2009 (prospective registration).

  10. Clinical trial allocation in multinational pharmaceutical companies – a qualitative study on influential factors

    DEFF Research Database (Denmark)

    Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik

    2017-01-01

    (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting......Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were...... trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities...

  11. Endobronchial intubation detected by insertion depth of endotracheal tube, bilateral auscultation, or observation of chest movements: randomised trial.

    Science.gov (United States)

    Sitzwohl, Christian; Langheinrich, Angelika; Schober, Andreas; Krafft, Peter; Sessler, Daniel I; Herkner, Harald; Gonano, Christopher; Weinstabl, Christian; Kettner, Stephan C

    2010-11-09

    To determine which bedside method of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity. Prospective randomised blinded study. Department of anaesthesia in tertiary academic hospital. 160 consecutive patients (American Society of Anesthesiologists category I or II) aged 19-75 scheduled for elective gynaecological or urological surgery. Patients were randomly assigned to eight study groups. In four groups, an endotracheal tube was fibreoptically positioned 2.5-4.0 cm above the carina, whereas in the other four groups the tube was positioned in the right mainstem bronchus. The four groups differed in the bedside test used to verify the position of the endotracheal tube. To determine whether the tube was properly positioned in the trachea, in each patient first year residents and experienced anaesthetists were randomly assigned to independently perform bilateral auscultation of the chest (auscultation); observation and palpation of symmetrical chest movements (observation); estimation of the position of the tube by the insertion depth (tube depth); or a combination of all three (all three). Correct and incorrect judgments of endotracheal tube position. 160 patients underwent 320 observations by experienced and inexperienced anaesthetists. First year residents missed endobronchial intubation by auscultation in 55% of cases and performed significantly worse than experienced anaesthetists with this bedside test (odds ratio 10.0, 95% confidence interval 1.4 to 434). With a sensitivity of 88% (95% confidence interval 75% to 100%) and 100%, respectively, tube depth and the three tests combined were significantly more sensitive for detecting endobronchial intubation than auscultation (65%, 49% to 81%) or observation(43%, 25% to 60%) (Pauscultation to detect inadvertent endobronchial intubation. But even experienced physicians will benefit from inserting tubes to 20-21 cm in women and 22-23 cm in men, especially when high

  12. 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

  13. The Healthy Steps Study: A randomized controlled trial of a pedometer-based Green Prescription for older adults. Trial protocol

    Directory of Open Access Journals (Sweden)

    Schluter Philip J

    2009-11-01

    Full Text Available 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 Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention, and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire, quality of life (SF-36 and EQ-5D, depressive symptoms (Geriatric Depression Scale, blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test and falls and adverse events (self-report. Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. Discussion The findings from the Healthy Steps trial are due in late

  14. Rationale, Design, and Methodology of the APOLLON trial: A comPrehensive, ObservationaL registry of heart faiLure with midrange and preserved ejectiON fraction.

    Science.gov (United States)

    Özlek, Bülent; Özlek, Eda; Çelik, Oğuzhan; Çil, Cem; Doğan, Volkan; Tekinalp, Mehmet; Zencirkıran Ağuş, Hicaz; Kahraman, Serkan; Ösken, Altuğ; Rencüzoğulları, İbrahim; Tanık, Veysel Ozan; Bekar, Lütfü; Çakır, Mustafa Ozan; Kaya, Bedri Caner; Tibilli, Hakan; Çelik, Yunus; Başaran, Özcan; Mert, Kadir Uğur; Sevinç, Samet; Demirci, Erkan; Dondurmacı, Engin; Biteker, Murat

    2018-05-01

    Although almost half of chronic heart failure (HF) patients have mid-range (HFmrEF) and preserved left-ventricular ejection fraction (HFpEF), no studies have been carried out with these patients in our country. This study aims to determine the demographic characteristics and current status of the clinical background of HFmrEF and HFpEF patients in a multicenter trial. A comPrehensive, ObservationaL registry of heart faiLure with mid range and preserved ejectiON fraction (APOLLON) trial will be an observational, multicenter, and noninterventional study conducted in Turkey. The study population will include 1065 patients from 12 sites in Turkey. All data will be collected at one point in time and the current clinical practice will be evaluated (ClinicalTrials.gov number NCT03026114). We will enroll all consecutive patients admitted to the cardiology clinics who were at least 18 years of age and had New York Heart Association class II, III, or IV HF, elevated brain natriuretic peptide levels within the last 30 days, and an left ventricular ejection fraction (LVEF) of at least 40%. Patients fulfilling the exclusion criteria will not be included in the study. Patients will be stratified into two categories according to LVEF: mid-range EF (HFmrEF, LVEF 40%-49%) and preserved EF (HFpEF, LVEF ≥50%). Regional quota sampling will be performed to ensure that the sample was representative of the Turkish population. Demographic, lifestyle, medical, and therapeutic data will be collected by this specific survey. The APOLLON trial will be the largest and most comprehensive study in Turkey evaluating HF patients with a LVEF ≥40% and will also be the first study to specifically analyze the recently designated HFmrEF category.

  15. Exploring interprofessional, interagency multimorbidity care: case study based observational research

    Science.gov (United States)

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

    2017-01-01

    Background The increase in multimorbidity or co-occurring chronic illnesses is a leading healthcare concern. Patients with multimorbidity require ongoing care from many different professionals and agencies, and often report a lack of integrated care. Objective To explore the daily help-seeking behaviours of patients with multimorbidity, including which health professionals they seek help from, how professionals work together, and perceptions and characteristics of effective interprofessional, interagency multimorbidity care. Design Using a case study observational research design, multiple data sources were assembled for four patients with multimorbidity, identified by two general practitioners in New Zealand. In this paper, two case studies are presented, including the recorded instances of contact and communication between patients and professionals, and between professionals. Professional interactions were categorized as consultation, coordination, or collaboration. Results The two case studies illustrated two female patients with likely similar educational levels, but with different profiles of multimorbidity, social circumstances, and personal capabilities, involving various professionals and agencies. Engagement between professionals showed varying levels of interaction and a lack of clarity about leadership or care coordination. The majority of interactions were one-to-one consultations and rarely involved coordination and collaboration. Patients were rarely included in communications between professionals. Conclusion Cases constructed from multiple data sources illustrate the complexity of day-to-day, interprofessional, interagency multimorbidity care. While consultation is the most frequent mode of professional interaction, targeted coordinated and collaborative interactions (including the patient) are highly effective activities. Greater attention should be given to developing and facilitating these interactions and determining who should lead them. PMID

  16. Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

    Science.gov (United States)

    Merali, Zamir; Wilson, Jefferson R

    2017-11-01

    Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

  17. Coordinated Regional Benefit Studies of Coastal Ocean Observing Systems

    National Research Council Canada - National Science Library

    Kite-Powell, Hauke L; Colgan, Charles S; Luger, Michael; Wieand, Ken; Pulsipher, Allan; Pendleton, Linwood; Wellman, Katherine; Pelsoci, Tom

    2003-01-01

    .... The authors will first produce regional "inventories" of ocean observation user sectors, including information about the physical and economic scale of their activities, how products from improved...

  18. Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis

    Science.gov (United States)

    Gurung, Vinita; Williamson, Catherine; Chappell, Lucy; Chambers, Jenny; Briley, Annette; Pipkin, Fiona Broughton; Thornton, Jim

    2009-01-01

    Background Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 4500 women per year in the UK. Affected women develop itching and occasionally jaundice. More importantly, the condition is associated with premature delivery, fetal distress and is believed to be an important cause of stillbirth. However, even now, there is no clear evidence as to whether the most popular treatment, a drug called ursodeoxycholic acid is beneficial to the baby, or even if it is safe in pregnancy. Nor do we know whether planned early delivery of the baby at 37–38 weeks, another popular treatment, does more good than harm. A randomised trial to evaluate both ursodeoxycholic acid and timed delivery is needed but will be complicated and expensive. We plan a preliminary study, Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis (Acronym PITCH- Pregnancy Intervention Trial in Cholestasis) trial, to evaluate the feasibility of a larger trial. The trial is funded by the NHS Research for Patient Benefit (RfPB) Programme. Methods PITCH is a multi-centre, double blinded, randomised, controlled, factorial design trial. The trial is being run in six UK centres and women with obstetric cholestasis will be recruited for eighteen months. In this pilot trial we aim to collect data to finalise the design for the main trial. This will include measuring trial recruitment rate, including recruitment to each factorial comparison separately. We will also measure the spectrum of disease among recruits and non-recruits and compliance with the four possible treatment allocations. We will use these data to design the main trial. Discussion The ultimate aim of the main trial is to enable clinicians to manage this condition more effectively. If it transpires that ursodeoxycholic acid and early delivery are both safe and effective then steps will be taken to ensure that all women with OC who could benefit from them receives this treatment

  19. Corneal permeability changes in dry eye disease: an observational study.

    Science.gov (United States)

    Fujitani, Kenji; Gadaria, Neha; Lee, Kyu-In; Barry, Brendan; Asbell, Penny

    2016-05-13

    Diagnostic tests for dry eye disease (DED), including ocular surface disease index (OSDI), tear breakup time (TBUT), corneal fluorescein staining, and lissamine staining, have great deal of variability. We investigated whether fluorophotometry correlated with previously established DED diagnostic tests and whether it could serve as a novel objective metric to evaluate DED. Dry eye patients who have had established signs or symptoms for at least 6 months were included in this observational study. Normal subjects with no symptoms of dry eyes served as controls. Each eye had a baseline fluorescein scan prior to any fluorescein dye. Fluorescein dye was then placed into both eyes, rinsed with saline solution, and scanned at 5, 10, 15, and 30 min. Patients were administered the following diagnostic tests to correlate with fluorophotometry: OSDI, TBUT, fluorescein, and lissamine. Standard protocols were used. P eyes from 25 patients (DED = 22 eyes, 11 patients; Normal = 28 eyes, 14 patients) were included. Baseline scans of the dry eye and control groups did not show any statistical difference (p = 0.84). Fluorescein concentration of DED and normal patients showed statistical significance at all time intervals (p eyes up to 30 min after fluorescein dye instillation. There may be an aspect of DED that is missed in the current regimen of DED tests and only captured with fluorophotometry. Adding fluorophotometry may be useful in screening, diagnosing, and monitoring patients with DED.

  20. Observational study of drug-drug interactions in oncological inpatients

    Directory of Open Access Journals (Sweden)

    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.

  1. 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.

  2. 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.

  3. An observational study of disk-population globular clusters

    International Nuclear Information System (INIS)

    Armandroff, T.E.

    1988-01-01

    Integrated-light spectroscopy was obtained for twenty-seven globular clusters at the Ca II infrared triplet. Line strengths and radial velocities were measured from the spectra. For the well-studied clusters in the sample, the strength of the CA II lines is very well correlated with previous metallicity estimates obtained using a variety of techniques. The greatly reduced effect of interstellar extinction at these wavelengths compared to the blue region of the spectrum has permitted observations of some of the most heavily reddened clusters in the Galaxy. For several such clusters, the Ca II triplet metallicities are in poor agreement with metallicity estimates from infrared photometry by Malkan. Color-magnitude diagrams were constructed for six previously unstudied metal-rich globular clusters and for the well-studied cluster 47 Tuc. The V magnitudes of the horizontal branch stars in the six clusters are in poor agreement with previous estimates based on secondary methods. The horizontal branch morphologies and reddenings of the program clusters were also determined. Using the improved set of metallicities, radial velocities, and distance moduli, the spatial distribution, kinematics, and metallicity distribution of the Galactic globulars were analyzed. The revised data supports Zinn's conclusion that the metal-rich clusters form a highly flattened, rapidly rotating disk system, while the metal-poor clusters make up the familiar, spherically distributed, slowly rotating halo population. The scale height, metallicity distribution, and kinematics of the metal-rich globulars are in good agreement with those of the stellar thick disk. Luminosity functions were constructed, and no significant difference is found between disk and halo samples. Metallicity gradients seem to be present in the disk cluster system. The implications of these results for the formation and evol

  4. Giant cell arteritis: a multicenter observational study in Brazil

    Directory of Open Access Journals (Sweden)

    Alexandre Wagner Silva de Souza

    2013-01-01

    Full Text Available OBJECTIVE: To describe demographic features, disease manifestations and therapy in patients with giant cell arteritis from referral centers in Brazil. METHODS: A retrospective cohort study was performed on 45 giant cell arteritis patients from three university hospitals in Brazil. Diagnoses were based on the American College of Rheumatology classification criteria for giant cell arteritis or temporal artery biopsy findings. RESULTS: Most patients were Caucasian, and females were slightly more predominant. The frequencies of disease manifestations were as follows: temporal headache in 82.2%, neuro-ophthalmologic manifestations in 68.9%, jaw claudication in 48.9%, systemic symptoms in 44.4%, polymyalgia rheumatica in 35.6% and extra-cranial vessel involvement in 17.8% of cases. Aortic aneurysms were observed in 6.6% of patients. A comparison between patients with biopsy-proven giant cell arteritis and those without temporal artery biopsies did not yield significant differences in disease manifestations. All patients were treated with oral prednisone, and intravenous methylprednisolone was administered to nearly half of the patients. Methotrexate was the most commonly used immunosuppressive agent, and low-dose aspirin was prescribed to the majority of patients. Relapses occurred in 28.9% of patients, and aspirin had a protective effect against relapses. Females had higher prevalences of polymyalgia rheumatica, systemic manifestations and jaw claudication, while permanent visual loss was more prevalent in men. CONCLUSIONS: Most of the clinical features of Brazilian giant cell arteritis patients were similar to those found in other studies, except for the high prevalence of neuro-ophthalmic manifestations and permanent blindness in the Brazilian patients. Aspirin had a protective effect on relapses.

  5. 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.

  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. Endovascular control of haemorrhagic urological emergencies: an observational study

    Directory of Open Access Journals (Sweden)

    Thorpe Peter

    2006-09-01

    Full Text Available Abstract Background Transarterial embolisation (TAE is an effective method in control of haemorrhage irrespective of the nature of urological emergency. As the technique and technology have evolved, it is now possible to perform highly selective embolisation. The aim of this study was to critically appraise feasibility and efficacy of therapeutic TAE in control of haemorrhagic urological emergencies using selective and non-selective embolisation. Specifically, we aimed to assess the impact of timing of embolisation on the requirement of blood transfusion and long-term morphological and functional follow-up of embolised organs. Methods This is a single institutional observational study carried out between March 1992 and March 2006. Records of all patients who underwent selective and non-selective angioembolisation to control bleeding in urological emergencies were reviewed. Data on success rate, periprocedural complications, timing of embolisation, requirement of blood transfusion and the long-term morphological and functional outcomes of embolised organs was recorded. Results Fourteen patients underwent endovascular control of bleeding as a result of trauma, iatrogenic injury and spontaneous perinephric haemorrhage during a period of 14 years. All these patients would have required emergency open surgery without the option of embolisation procedure. The mean time between the first presentation and embolisation was 22 hours (range 30 minutes to 60 hours. Mean pre-embolisation transfusion requirement was 6.8 units (range 0–22 units. None of the patients with successful embolisation required post-procedural blood transfusion. Permanent haemostasis was achieved in all but one patient, who required emergency nephrectomy. There were no serious procedure related post-embolisation complications. Conclusion Endovascular control using transarterial angioembolisation is an effective method for managing haematuria or haemorrhage in urological emergencies

  8. [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.

  9. The G-spot: an observational MRI pilot study.

    Science.gov (United States)

    Maratos, Y K; Gombergh, R; Cornier, E; Minart, J P; Amoretti, N; Mpotsaris, A

    2016-08-01

    To identify a G-spot complex (GSC) in vivo in MRI examinations at 1.5 Tesla field strength. Observational study. Single centre. Twenty-one consecutive patients (January-March 2014). Imaging analysis of routine imaging protocols for usual medical indications with and without concomitant opacification of the vaginal cavity with inert ultrasound gel. The gel distends the otherwise collapsed vaginal walls, allowing for an improved discrimination of anatomic features. The macroscopic and histological results recently derived from the dissections of fresh cadavers by Ostrzenski et al. were translated into imaging characteristics to be expected in the respective MRI sequences (e.g. T1- and T2-weighted) in search of an in vivo correlate of the GSC. Age, menopause status, medical indication and diagnosis were co-variables. To analyse primarily whether MRI imaging is able to depict a distinct morphological entity in vivo matching the GSC, based on anatomical descriptions published recently. The elaboration of an appropriate MRI-imaging protocol was a secondary aim. A total of 21 studies were obtained. A GSC was identified within the anterior vaginal wall in 13/21 patients (62%). In all, 10/21 (48%) had vaginal gel opacification. We identified a GSC in 10/10 patients (100%) with opacification in all three planes of the T2 images. This was only true for 3/11 cases (27%) without opacification. There is evidence for an in vivo morphological correlate to the postmortem anatomical findings of a GSC described by Ostrzenski et al.; its visibility in MRI imaging can be significantly improved with vaginal opacification by ultrasound gel. Identification of G-spot by MRI with vaginal gel-opacification in 13/21 patients. © 2016 Royal College of Obstetricians and Gynaecologists.

  10. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  11. 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

  12. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  13. Observation and Study of Proton Aurora by using Scanning Photometer

    Science.gov (United States)

    Mochizuki, T.; Ono, T.; Kadokura, A.; Sato, N.

    2009-12-01

    The proton auroras have significant differences from electron auroras in their spectral shape. They show Doppler-shifted and broadened spectra: the spectra have Doppler-shifted (~0.5 nm shorter) peak and both bluewing (~2-4 nm) and redwing (~1.5 nm) extending. Energy spectra of precipitating protons have been estimated from this shape. Recently it is found that the intensity in the extent of the blue wing reflects more effectively by the change of the mean energy of precipitating protons than the shift of peak wavelength [Lanchester et al., 2003]. Another character of the H-beta aurora is that it is diffuse form because a proton becomes hydrogen atom due to a charge-exchange reaction with atmospheric constituent and then possible to move across the magnetic field line. By using a scanning photometer, the movement of the proton auroral belt and change of a spectrum shape associated with the variation of proton source region due to storm and substorm were reported, however, not discussed in detail yet [Deehr and Lummerzheim, 2001]. The purpose of this study is to obtain the detail characteristics of H-beta aurora for understanding of source region of energetic protons in the magnetosphere. For this purpose, a new meridian-scanning photometer (SPM) was installed at Husafell station in Iceland in last summer season and Syowa Station, Antarctica. It will contribute to investigate the distribution of energetic protons and plasma waves which cause the pitch angle scattering in the magnetosphere. The meridian-scanning photometer is able to observe at five wavelengths for H-beta emission. One channel is to measure the background level. By analyzing the data obtained by the SPM, the H-beta spectrum can be estimated by fitting a model function with it. Then it is possible to obtain distribution of precipitating protons in north-south direction. It is also possible to estimate an energy spectrum of precipitating proton, simultaneously. The instrumental parameters of the SPM is

  14. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial.

    Science.gov (United States)

    Read, Robert C; Baxter, David; Chadwick, David R; Faust, Saul N; Finn, Adam; Gordon, Stephen B; Heath, Paul T; Lewis, David J M; Pollard, Andrew J; Turner, David P J; Bazaz, Rohit; Ganguli, Amitava; Havelock, Tom; Neal, Keith R; Okike, Ifeanyichukwu O; Morales-Aza, Begonia; Patel, Kamlesh; Snape, Matthew D; Williams, John; Gilchrist, Stefanie; Gray, Steve J; Maiden, Martin C J; Toneatto, Daniela; Wang, Huajun; McCarthy, Maggie; Dull, Peter M; Borrow, Ray

    2014-12-13

    Meningococcal conjugate vaccines protect individuals directly, but can also confer herd protection by interrupting carriage transmission. We assessed the effects of meningococcal quadrivalent glycoconjugate (MenACWY-CRM) or serogroup B (4CMenB) vaccination on meningococcal carriage rates in 18-24-year-olds. In this phase 3, observer-blind, randomised controlled trial, university students aged 18-24 years from ten sites in England were randomly assigned (1:1:1, block size of three) to receive two doses 1 month apart of Japanese Encephalitis vaccine (controls), 4CMenB, or one dose of MenACWY-CRM then placebo. Participants were randomised with a validated computer-generated random allocation list. Participants and outcome-assessors were masked to the treatment group. Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over 1 year. Primary outcomes were cross-sectional carriage 1 month after each vaccine course. Secondary outcomes included comparisons of carriage at any timepoint after primary analysis until study termination. Reactogenicity and adverse events were monitored throughout the study. Analysis was done on the modified intention-to-treat population, which included all enrolled participants who received a study vaccination and provided at least one assessable swab after baseline. This trial is registered with ClinicalTrials.gov, registration number NCT01214850. Between Sept 21 and Dec 21, 2010, 2954 participants were randomly assigned (987 assigned to control [984 analysed], 979 assigned to 4CMenB [974 analysed], 988 assigned to MenACWY-CRM [983 analysed]); 33% of the 4CMenB group, 34% of the MenACWY-CRM group, and 31% of the control group were positive for meningococcal carriage at study entry. By 1 month, there was no significant difference in carriage between controls and 4CMenB (odds ratio 1·2, 95% CI 0·8-1·7) or MenACWY-CRM (0·9, [0·6-1·3]) groups. From 3 months after dose two, 4CMen

  15. Improved survival for multiple myeloma in denmark based on autologous stem cell transplantation and novel drug therapy in collaborative trials: analysis of accrual, prognostic variables, selection bias, and clinical behavior on survival in more than 1200 patients in trials of the nordic myeloma study group

    DEFF Research Database (Denmark)

    Johnsen, Hans Erik; Klausen, Tobias W; Boegsted, Martin

    2010-01-01

    An unexplained survival difference was observed in the Nordic Myeloma Study Group (NMSG) high-dose therapy trial 5/94 in Denmark compared with Sweden and Norway; however, this difference was eliminated in the subsequent NMSG trial 7/98. It was hypothesized that a detailed analysis of potential ex...

  16. 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

  17. 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.

  18. Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism.

    Science.gov (United States)

    Mouti, Anissa; Reddihough, Dinah; Marraffa, Catherine; Hazell, Philip; Wray, John; Lee, Katherine; Kohn, Michael

    2014-06-16

    Serotonin reuptake inhibitors (SSRIs) are commonly prescribed off-label for children with autism. To date, clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results. The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice. The aim of the Fluoxetine for Autistic Behaviors (FAB) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo, for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder (ASD). The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored. The FAB study is a multicenter, double-blinded, randomized controlled trial, funded by the Australian Government's National Health and Medical Research Council (NHMRC) grant. Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD. Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period. Medication will be titrated over the first four weeks. Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale (CGI). The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders (CYBOCS-PDD), administered at baseline and 16 weeks. Secondary outcome measures include the Aberrant Behaviour Scale (ABC), the Spence Children's Anxiety Scale Parent Report (SCAS-P), and the Repetitive Behaviors Scale (RBS-R), measured at baseline and 16 weeks. Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab. Continuous outcomes, including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression. Binary outcomes will be compared using

  19. Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

    2014-10-29

    Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

  20. 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.

  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. Observational Study Designs for Comparative Effectiveness Research: An Alternative Approach to Close Evidence Gaps in Head-and-Neck Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Goulart, Bernardo H.L., E-mail: bhg@uw.edu [Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Hutchinson Institute for Cancer Outcomes Research (HICOR), Seattle, Washington (United States); University of Washington, Seattle, Washington (United States); Ramsey, Scott D. [Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Hutchinson Institute for Cancer Outcomes Research (HICOR), Seattle, Washington (United States); University of Washington, Seattle, Washington (United States); Parvathaneni, Upendra [Department of Radiation Oncology, University of Washington, Seattle, Washington (United States); University of Washington, Seattle, Washington (United States)

    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.

  3. 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

  4. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  5. Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

    Science.gov (United States)

    Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

    2017-08-01

    There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

  6. 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....

  7. Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

    Science.gov (United States)

    Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

    2017-06-01

    Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

  8. 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

  9. Outcomes from massive paracetamol overdose: a retrospective observational study.

    Science.gov (United States)

    Marks, Daniel J B; Dargan, Paul I; Archer, John R H; Davies, Charlotte L; Dines, Alison M; Wood, David M; Greene, Shaun L

    2017-06-01

    This article is commented on by Bateman DN and Dear JW. Should we treat very large paracetamol overdose differently? Br J Clin Pharmacol 2017; 83: 1163-5. https://doi.org/10.1111/bcp.13279 AIMS: Treatment of paracetamol (acetaminophen) overdose with acetylcysteine is standardized, with dose determined only by patient weight. The validity of this approach for massive overdoses has been questioned. We systematically compared outcomes in massive and non-massive overdoses, to guide whether alternative treatment strategies should be considered, and whether the ratio between measured timed paracetamol concentrations (APAP pl ) and treatment nomogram thresholds at those time points (APAP t ) provides a useful assessment tool. This is a retrospective observational study of all patients (n = 545) between 2005 and 2013 admitted to a tertiary care toxicology service with acute non-staggered paracetamol overdose. Massive overdoses were defined as extrapolated 4-h plasma paracetamol concentrations >250 mg l -1 , or reported ingestions ≥30 g. Outcomes (liver injury, coagulopathy and kidney injury) were assessed in relation to reported dose and APAP pl :APAP t ratio (based on a treatment line through 100 mg l -1 at 4 h), and time to acetylcysteine. Ingestions of ≥30 g paracetamol correlated with higher peak serum aminotransferase (r = 0.212, P paracetamol overdose are at higher risk of organ injury, even when acetylcysteine is administered early. Enhanced therapeutic strategies should be considered in those who have an APAP pl :APAP t  ≥ 3. Novel biomarkers of incipient liver injury and abbreviated acetylcysteine regimens require validation in this patient cohort. © 2016 The British Pharmacological Society.

  10. Motivators of enrolment in HIV vaccine trials: a review of HIV vaccine preparedness studies.

    Science.gov (United States)

    Dhalla, Shayesta; Poole, Gary

    2011-11-01

    HIV vaccine preparedness studies (VPS) are important precursors to HIV vaccine trials. As well, they contribute to an understanding of motivators and barriers for participation in hypothetical HIV vaccine trials. Motivators can take the form of altruism and a desire for social benefits. Perceived personal benefits, including psychological, personal, and financial well-being, may also motivate participation. The authors performed a systematic review of HIV VPS using the Cochrane Database for Systematic Reviews, Medline, PubMed, Embase, and Google Scholar. The authors independently searched the literature for individual HIV VPS that examined motivators of participation in a hypothetical HIV vaccine trial, using the same search strategy. As the denominators employed in the literature varied across studies, the denominators were standardized to the number of respondents per survey item, regardless of their willingness to participate (WTP) in an HIV vaccine trial. The authors retrieved eight studies on social benefits (i.e., altruism) and 11 studies on personal benefits conducted in the Organization for Economic Co-operation and Development (OECD) countries, as well as 19 studies on social benefits and 20 studies on personal benefits in the non-OECD countries. Various different forms of altruism were found to be the major motivators for participation in an HIV vaccine trial in both the OECD and the non-OECD countries. In a large number of studies, protection from HIV was cited as a personal motivator for participation in a hypothetical HIV vaccine trial in the OECD and the non-OECD countries. Knowledge of motivators can inform and target recruitment for HIV vaccine trials, although it must be remembered that hypothetical motivators may not always translate into motivators in an actual vaccine trial.

  11. Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study

    Science.gov (United States)

    2014-01-01

    Introduction Severe infections in intensive care patients show high morbidity and mortality rates. Linezolid is an antimicrobial drug frequently used in critically ill patients. Recent data indicates that there might be high variability of linezolid serum concentrations in intensive care patients receiving standard doses. This study was aimed to evaluate whether standard dosing of linezolid leads to therapeutic serum concentrations in critically ill patients. Methods In this prospective observational study, 30 critically ill adult patients with suspected infections received standard dosing of 600 mg linezolid intravenously twice a day. Over 4 days, multiple serum samples were obtained from each patient, in order to determine the linezolid concentrations by liquid chromatography tandem mass spectrometry. Results A high variability of serum linezolid concentrations was observed (range of area under the linezolid concentration time curve over 24 hours (AUC24) 50.1 to 453.9 mg/L, median 143.3 mg*h/L; range of trough concentrations (Cmin) linezolid concentrations over 24 hours and at single time points (defined according to the literature as AUC24  400 mg*h/L and Cmin > 10 mg/L) were observed for 7 of the patients. Conclusions A high variability of linezolid serum concentrations with a substantial percentage of potentially subtherapeutic levels was observed in intensive care patients. The findings suggest that therapeutic drug monitoring of linezolid might be helpful for adequate dosing of linezolid in critically ill patients. Trial registration Clinicaltrials.gov NCT01793012. Registered 24 January 2013. PMID:25011656

  12. Clinical Trials

    Medline Plus

    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  14. Clinical Trials

    Medline Plus

    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  17. Wrist-ankle acupuncture (WAA) for primary dysmenorrhea (PD) of young females: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chen, Yingfan; Tian, Sinan; Tian, Jing; Shu, Shi

    2017-08-22

    Primary dysmenorrhea (PD) is one of the most common health complaints all over the world, specifically among young females. Acupuncture has been employed to relieve the pain-based symptoms and to avoid the side effects of conventional medication, and wrist-ankle acupuncture (WAA) has confirmed analgesic efficacy for various types of pain. The aim of this study is to evaluate the immediate analgesia effect of WAA on PD of young females. This study will carry out a randomized parallel controlled single-blind trial to observe the immediate analgesia effect of WAA in PD of young females. Sixty participants who meet inclusion criteria will be recruited from September 2016 to September 2017 in Changhai hospital of China. They are randomly assigned to WAA therapy or sham acupuncture groups (30 patients for each group), and then receive real or sham acupuncture treatment, respectively. In this trial, the primary outcome measure is simple form of McGill pain questionnaire (SF-MPQ), while expectation and treatment credibility scale (ETCS), safety assessment, the COX menstrual symptom scale (CMSS), questionnaire about the feeling of being punctured are included in the secondary outcomes. This trial will be the first study protocol designed to evaluate the immediate analgesia effect of WAA in PD of young females. The strengths in methodology, including rigorous randomized, sham-controlled, participants-blinded and assessors-blinded, will guarantee the quality of this study. WAA doesn't require any needling sensation, so non-penetrating sham acupuncture can serve as an effective placebo intervention in this trial. Chinese Clinical Trial Registry (identifier: ChiCTR-IOR-16008546 ; registration date: 27 May 2016).

  18. Motivations and concerns about adolescent tuberculosis vaccine trial participation in rural Uganda: a qualitative study.

    Science.gov (United States)

    Buregyeya, Esther; Kulane, Asli; Kiguli, Juliet; Musoke, Phillipa; Mayanja, Harriet; Mitchell, Ellen Maeve Hanlon

    2015-01-01

    Research is being carried out to develop and test new potentially more effective tuberculosis vaccines. Among the vaccines being developed are those that target adolescents. This study explored the stakeholders' perceptions about adolescent participation in a hypothetical tuberculosis vaccine trial in Ugandan adolescents. Focus group discussions with adolescents, parents of infants and adolescents, and key informant interviews with community leaders and traditional healers were conducted. The majority of the respondents expressed potential willingness to allow their children participate in a tuberculosis vaccine trial. Main motivations for potential participation would be being able to learn about health-related issues. Hesitations included the notion that trial participation would distract the youths from their studies, fear of possible side effects of an investigational product, and potential for being sexually exploited by researchers. In addition, bad experiences from participation in previous research and doubts about the importance of research were mentioned. Suggested ways to motivate participation included: improved clarity on study purpose, risks, benefits and better scheduling of study procedures to minimize disruption to participants' academic schedules. Findings from this study suggest that the community is open to potential participation of adolescents in a tuberculosis vaccine trial. However, there is a need to communicate more effectively with the community about the purpose of the trial and its effects, including safety data, in a low-literacy, readily understood format. This raises a challenge to researchers, who cannot know all the potential effects of a trial product before it is tested.

  19. Do physiotherapy staff record treatment time accurately? An observational study.

    Science.gov (United States)

    Bagley, Pam; Hudson, Mary; Green, John; Forster, Anne; Young, John

    2009-09-01

    To assess the reliability of duration of treatment time measured by physiotherapy staff in early-stage stroke patients. Comparison of physiotherapy staff's recording of treatment sessions and video recording. Rehabilitation stroke unit in a general hospital. Thirty-nine stroke patients without trunk control or who were unable to stand with an erect trunk without the support of two therapists recruited to a randomized trial evaluating the Oswestry Standing Frame. Twenty-six physiotherapy staff who were involved in patient treatment. Contemporaneous recording by physiotherapy staff of treatment time (in minutes) compared with video recording. Intraclass correlation with 95% confidence interval and the Bland and Altman method for assessing agreement by calculating the mean difference (standard deviation; 95% confidence interval), reliability coefficient and 95% limits of agreement for the differences between the measurements. The mean duration (standard deviation, SD) of treatment time recorded by physiotherapy staff was 32 (11) minutes compared with 25 (9) minutes as evidenced in the video recording. The mean difference (SD) was -6 (9) minutes (95% confidence interval (CI) -9 to -3). The reliability coefficient was 18 minutes and the 95% limits of agreement were -24 to 12 minutes. Intraclass correlation coefficient for agreement between the two methods was 0.50 (95% CI 0.12 to 0.73). Physiotherapy staff's recording of duration of treatment time was not reliable and was systematically greater than the video recording.

  20. Economic return from the Women's Health Initiative estrogen plus progestin clinical trial: a modeling study.

    Science.gov (United States)

    Roth, Joshua A; Etzioni, Ruth; Waters, Teresa M; Pettinger, Mary; Rossouw, Jacques E; Anderson, Garnet L; Chlebowski, Rowan T; Manson, Joann E; Hlatky, Mark; Johnson, Karen C; Ramsey, Scott D

    2014-05-06

    The findings of the Women's Health Initiative (WHI) estrogen plus progestin (E+P) trial led to a substantial reduction in use of combined hormone therapy (cHT) among postmenopausal women in the United States. The economic effect of this shift has not been evaluated relative to the trial's $260 million cost (2012 U.S. dollars). To estimate the economic return from the WHI E+P trial. Decision model to simulate health outcomes for a "WHI scenario" with observed cHT use and a "no-WHI scenario" with cHT use extrapolated from the pretrial period. Primary analyses of WHI outcomes, peer-reviewed literature, and government sources. Postmenopausal women in the United States, aged 50 to 79 years, who did not have a hysterectomy. 2003 to 2012. Payer. Combined hormone therapy. Disease incidence, expenditure, quality-adjusted life-years, and net economic return. The WHI scenario resulted in 4.3 million fewer cHT users, 126,000 fewer breast cancer cases, 76,000 fewer cardiovascular disease cases, 263,000 more fractures, 145,000 more quality-adjusted life-years, and expenditure savings of $35.2 billion. The corresponding net economic return of the trial was $37.1 billion ($140 per dollar invested in the trial) at a willingness-to-pay level of $100,000 per quality-adjusted life-year. The 95% CI for the net economic return of the trial was $23.1 to $51.2 billion. No evaluation of indirect costs or outcomes beyond 2012. The WHI E+P trial made high-value use of public funds with a substantial return on investment. These results can contribute to discussions about the role of public funding for large, prospective trials with high potential for public health effects. National Heart, Lung, and Blood Institute.

  1. The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

    Science.gov (United States)

    Kim, Kwan-Ii; Jo, Junyoung

    2018-01-01

    Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

  2. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study.

    Science.gov (United States)

    Appelt, Ane L; Pløen, John; Harling, Henrik; Jensen, Frank S; Jensen, Lars H; Jørgensen, Jens C R; Lindebjerg, Jan; Rafaelsen, Søren R; Jakobsen, Anders

    2015-08-01

    Abdominoperineal resection is the standard treatment for patients with distal T2 or T3 rectal cancers; however, the procedure is extensive and mutilating, and alternative treatment strategies are being investigated. We did a prospective observational trial to assess whether high-dose radiotherapy with concomitant chemotherapy followed by observation (watchful waiting) was successful for non-surgical management of low rectal cancer. Patients with primary, resectable, T2 or T3, N0-N1 adenocarcinoma in the lower 6 cm of the rectum were given chemoradiotherapy (60 Gy in 30 fractions to tumour, 50 Gy in 30 fractions to elective lymph node volumes, 5 Gy endorectal brachytherapy boost, and oral tegafur-uracil 300 mg/m(2)) every weekday for 6 weeks. Endoscopies and biopsies of the tumour were done at baseline, throughout the course of treatment (weeks 2, 4, and 6), and 6 weeks after the end of treatment. We allocated patients with complete clinical tumour regression, negative tumour site biopsies, and no nodal or distant metastases on CT and MRI 6 weeks after treatment to the observation group (watchful waiting). We referred all other patients to standard surgery. Patients under observation were followed up closely with endoscopies and selected-site biopsies, with surgical resection given for local recurrence. The primary endpoint was local tumour recurrence 1 year after allocation to the observation group. This study is registered with ClinicalTrials.gov, number NCT00952926. Enrolment is closed, but follow-up continues for secondary endpoints. Between Oct 20, 2009, and Dec 23, 2013, we enrolled 55 patients. Patients were recruited from three surgical units throughout Denmark and treated in one tertiary cancer centre (Vejle Hospital, Vejle, Denmark). Of 51 patients who were eligible, 40 had clinical complete response and were allocated to observation. Median follow-up for local recurrence in the observation group was 23·9 months (IQR 15·3-31·0). Local recurrence in the

  3. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  4. Homeopathic drug therapy. Homeopathy in Chikungunya Fever and Post-Chikungunya Chronic Arthritis: an observational study.

    Science.gov (United States)

    Wadhwani, Gyandas G

    2013-07-01

    To observe the effect of homeopathic therapy in Chikungunya Fever (CF) and in Post-Chikungunya Chronic Arthritis (PCCA) in a primary health care setting. A prospective observational study was conducted at Delhi Government Homeopathic Dispensary, Aali Village, New Delhi, India, for a period of 6 months, from 1st October 2010 to 31st March 2011. 126 patients (75 CF, 51 PCCA) were enrolled based on predefined inclusion criteria. A single homeopathic medicine was prescribed for each patient after case taking with the help of Materia Medica and/or Repertory. Results were evaluated on the basis of visual analogue scale and symptom scores. Complete recovery was seen in 84.5% CF cases in a mean time of 6.8 days. 90% cases of PCCA recovered completely in a mean time of 32.5 days. Homeopathic therapy may be effective in CF and PCCA. A randomized controlled trial should be considered. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  5. The recruitment of patients to trials in head and neck cancer: a qualitative study of the EaStER trial of treatments for early laryngeal cancer.

    Science.gov (United States)

    Hamilton, D W; de Salis, I; Donovan, J L; Birchall, M

    2013-08-01

    We aimed to investigate the factors contributing to poor recruitment to the EaStER trial "Early Stage glottic cancer: Endoscopic excision or Radiotherapy" feasibility study. We performed a prospective qualitative assessment of the EaStER trial at three centres to investigate barriers to recruitment and implement changes. Methods used included semi-structured interviews, focus groups and audio-recordings of recruitment encounters. First, surgeons and recruiters did not all accept the primary outcome as the rationale for the trial. Surgeons did not always adhere to the trial eligibility criteria leading to variations between centres in the numbers of "eligible" patients. Second, as both treatments were considered equally successful, recruiters and patients focused on the pragmatics of the different trial arms, favouring surgery over radiotherapy. The lack of equipoise was reflected in the way recruiters presented trial information. Third, patient views, beliefs and preferences were not fully elicited or addressed by recruiters. Fourth, in some centres, logistical issues made trial participation difficult. This qualitative research identified several major issues that explained recruitment difficulties. While there was insufficient time to address these in the EaStER trial, several factors would need to be addressed to launch further RCTs in head and neck cancer. These include the need for clear ongoing agreement among recruiting clinicians regarding details in the study protocol; an understanding of the logistical issues hindering recruitment at individual centres; and training recruiters to enable them to explain the need for randomisation and the rationale for the RCT to patients.

  6. CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

    Science.gov (United States)

    Hutchings, Natalie; Wood, Wendy; Reading, Isabel; Walker, Erin; Blazeby, Jane M; Van't Hoff, William; Young, Bridget; Crawley, Esther M; Eaton, Simon; Chorozoglou, Maria; Sherratt, Frances C; Beasant, Lucy; Corbett, Harriet; Stanton, Michael P; Grist, Simon; Dixon, Elizabeth; Hall, Nigel J

    2018-03-02

    Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment

  7. Classroom Observation Practice in Career Schools: A Multiple Case Study

    Science.gov (United States)

    Withers, Marya G.

    2017-01-01

    Post-secondary career school educational leaders are charged with formulating sufficient, ongoing, and effective faculty development programming to ensure the delivery of quality education in their unique trade-expert led institutions. Classroom observations, which include substantive feedback exchanges from trained personnel are well documented…

  8. Study of observed microearthquakes at Masada Deep Borehole

    Science.gov (United States)

    Hofstetter, A.; Malin, P. E.

    2017-12-01

    Seismological measurements, conducted at great depths of several hundred of meters or even a few km, can provide useful information that one cannot get while conducting the measurements on the surface. We take advantage of Masada Deep borehole (MDBI), an abandoned oil well, for the installation of a seismometer at a large depth of 1,256 m (1,516 bsl). The station is located in the near vicinity of the East Masada fault, part of the Western Boundary Fault of the Dead Sea basin. We present seismic observations of microearthquakes which occurred along the Dead Sea fault (DSF). Many of them were not recorded by the Israel Seismic Network (ISN). The quiet site of the station has an obvious advantage in detection and identification of earthquakes and explosions. For example, the station detects about 30% more quarry explosions as compared to observations of the ISN. We demonstrate that borehole seismograms are clearer than the on-surface observations of nearby seismometer. We lowered the magnitude scale of observed events down to about M≈-3. Many of the earthquakes, sometimes clusters, occurred underneath the MDBI at depths of 10-25 km, having special signature. Using the cross-correlation technique we present several series of seismic activity either underneath the station or along the DSF. Frequency-magnitude relationship, known also as Gutenberg-Richter relationship, is somewhat higher than the determined value for the whole Dead Sea Fault.

  9. Mother-Father-Infant Interaction: A Naturalistic Observational Study.

    Science.gov (United States)

    Belsky, Jay

    1979-01-01

    Investigates infant preferences for interaction with mother v father, similarities and differences in maternal and paternal behavior, and the influence of a second parent's presence on parent-infant interaction. Families with infants 15 months of age were observed in their own homes. (Author/SS)

  10. Systemic therapy for vulval Erosive Lichen Planus (the 'hELP' trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Simpson, Rosalind C; Murphy, Ruth; Bratton, Daniel J; Sydes, Matthew R; Wilkes, Sally; Nankervis, Helen; Dowey, Shelley; Thomas, Kim S

    2016-01-04

    Erosive lichen planus affecting the vulva (ELPV) is a relatively rare, chronic condition causing painful raw areas in the vulvovaginal region. Symptoms are pain and burning, which impact upon daily living. There is paucity of evidence regarding therapy. A 2012 Cochrane systematic review found no randomised controlled trials (RCTs) in this field. Topically administered corticosteroids are the accepted first-line therapy: however, there is uncertainty as to which second-line treatments to use. Several systemic agents have been clinically noted to show promise for ELPV refractory to topically administered corticosteroids but there is no RCT evidence to support these. The 'hELP' study is a RCT with an internal pilot phase designed to provide high-quality evidence. The objective is to test whether systemic therapy in addition to standard topical therapy is a beneficial second-line treatment for ELPV. Adjunctive systemic therapies used are hydroxychloroquine, methotrexate, mycophenolate mofetil and prednisolone. Topical therapy plus a short course of prednisolone given orally is considered the comparator intervention. The trial is a four-armed, open-label, pragmatic RCT which uses a blinded independent clinical assessor. To provide 80 % power for each comparison, 96 participants are required in total. The pilot phase aims to recruit 40 participants. The primary clinical outcome is the proportion of patients achieving treatment success at 6 months. 'Success' is defined by a composite measure of Patient Global Assessment score of 0 or 1 on a 4-point scale plus improvement from baseline on clinical photographs scored by a clinician blinded to treatment allocation. Secondary clinical outcomes include 6-month assessment of: (1) Reduction in pain/soreness; (2) Global assessment of disease; (3) Response at other affected mucosal sites; (4) Hospital Anxiety and Depression Scale scores; (5) Sexual function; (6) Health-related quality of life using 'Short Form 36' and 'Skindex

  11. Aprotinin vs. tranexamic acid in isolated coronary artery bypass surgery: A multicentre observational study.

    Science.gov (United States)

    Deloge, Elsa; Amour, Julien; Provenchère, Sophie; Rozec, Bertrand; Scherrer, Bruno; Ouattara, Alexandre

    2017-05-01

    Aprotinin appears to be more efficacious than lysine analogues to reduce bleeding and transfusion of blood products in high-transfusion-risk cardiac surgical patients. However, in isolated coronary artery bypass graft (CABG) surgery, the results from head-to-head trials remain less conclusive. Our objective was to compare the efficacies and safety of aprotinin and tranexamic acid (TXA) in patients undergoing isolated on-pump CABG. A multicentre before-and-after study pooling individual data from published trials and unpublished data from three other databases. Four tertiary care teaching hospitals (Haut-Lévêque Hospital in Bordeaux, Pitié-Salpêtrière Hospital and Bichat-Claude Bernard Hospital in Paris, and Laennec Hospital in Nantes). We included data of 2496 isolated on-pump CABG surgery patients who received either aprotinin between November 2003 and May 2008 (n = 1267) or TXA between November 2007 and November 2013 (n = 1229). The primary outcome was total blood loss within 24 h after operation. Secondary outcomes were transfusion of blood products, reoperation for bleeding, renal replacement therapy, ICU length of stay and in-hospital mortality. Adjusted mean (SEM) 24-h blood loss after surgery [483 (11) vs. 634 (11) ml, P < 0.0001] and the proportion of patients requiring intraoperative blood product transfusion (32.7 vs. 46.5%, P = 0.01) were lower in aprotinin-treated patients. No difference was observed with regard to reoperations for bleeding, renal replacement therapy and in-hospital mortality. However, patients receiving aprotinin had a significantly shorter adjusted ICU length of stay. In patients undergoing isolated CABG, aprotinin was more effective than TXA in reducing postoperative blood loss, and no safety concerns were identified. The benefits of aprotinin should be considered when evaluating the risk of major blood loss and transfusion in patients scheduled for isolated CABG surgery.

  12. A simulation study on estimating biomarker-treatment interaction effects in randomized trials with prognostic variables.

    Science.gov (United States)

    Haller, Bernhard; Ulm, Kurt

    2018-02-20

    To individualize treatment decisions based on patient characteristics, identification of an interaction between a biomarker and treatment is necessary. Often such potential interactions are analysed using data from randomized clinical trials intended for comparison of two treatments. Tests of interactions are often lacking statistical power and we investigated if and how a consideration of further prognostic variables can improve power and decrease the bias of estimated biomarker-treatment interactions in randomized clinical trials with time-to-event outcomes. A simulation study was performed to assess how prognostic factors affect the estimate of the biomarker-treatment interaction for a time-to-event outcome, when different approaches, like ignoring other prognostic factors, including all available covariates or using variable selection strategies, are applied. Different scenarios regarding the proportion of censored observations, the correlation structure between the covariate of interest and further potential prognostic variables, and the strength of the interaction were considered. The simulation study revealed that in a regression model for estimating a biomarker-treatment interaction, the probability of detecting a biomarker-treatment interaction can be increased by including prognostic variables that are associated with the outcome, and that the interaction estimate is biased when relevant prognostic variables are not considered. However, the probability of a false-positive finding increases if too many potential predictors are included or if variable selection is performed inadequately. We recommend undertaking an adequate literature search before data analysis to derive information about potential prognostic variables and to gain power for detecting true interaction effects and pre-specifying analyses to avoid selective reporting and increased false-positive rates.

  13. Reliability of radiographic observations recorded on a proforma measured using inter- and intra-observer variation: a preliminary study.

    Science.gov (United States)

    Saunders, M B; Gulabivala, K; Holt, R; Kahan, R S

    2000-05-01

    The aim of this preliminary study was to test the reliability of radiographic evaluation of features of endodontic interest using a newly devised data collection system. Twelve endodontic MSc postgraduate students and one specialist endodontist examined sample radiographs derived from a random selection of 42 patients seen previously on an Endodontic New Patient Clinic (EDI). Each student examined a random selection of 8-9 roots on periapical radiographs of single- and multirooted teeth, with and without previous root canal therapy and 3-4 dental panoramic tomograms (DPTs). A total of 100 roots were examined. A proforma was used to record observations on 67 radiographic features using predefined criteria. Intra-observer agreement was tested by asking the students to re-examine the radiographs. The principle investigator and the specialist endodontist examined the same radiographs and devised a Gold Standard using the same criteria. This was compared with the student assessments to determine inter-observer variation. The postgraduates then attended a revision session on the use of the form. Each student subsequently examined 8-9 different roots from the pool of radiographs. A further assessment of inter-observer variation was made by comparing these observations with the Gold Standard. Of the 67 radiographic features, only 25 had sufficient response to allow statistical analysis. Kappa values for intra- and inter-observer variation were estimated. These varied depending on the particular radiographic feature being assessed. Fifteen out of 25 intra-observer recordings showed 'good' or 'very good' Kappa agreement, but only three out of 25 inter-observer observations achieved 'good' or 'very good' values. Inter-observer variation was improved following the revision session with 16 out of 25 observations achieving 'good' or 'very good' Kappa agreement. Modification to the proforma, the criteria used, and training for radiographic assessment were considered necessary to

  14. A randomized phase II chemoprevention trial of 13-CIS retinoic acid with or without alpha tocopherol or observation in subjects at high risk for lung cancer.

    Science.gov (United States)

    Kelly, Karen; Kittelson, John; Franklin, Wilbur A; Kennedy, Timothy C; Klein, Catherine E; Keith, Robert L; Dempsey, Edward C; Lewis, Marina; Jackson, Mary K; Hirsch, Fred R; Bunn, Paul A; Miller, York E

    2009-05-01

    No chemoprevention strategies have been proven effective for lung cancer. We evaluated the effect of 13-cis retinoic acid (13-cis RA), with or without alpha tocopherol, as a lung cancer chemoprevention agent in a phase II randomized controlled clinical trial of adult subjects at high risk for lung cancer as defined by the presence of sputum atypia, history of smoking, and airflow obstruction, or a prior surgically cured nonsmall cell lung cancer (disease free, >3 years). Subjects were randomly assigned to receive either 13-cis RA, 13-cis RA plus alpha tocopherol (13-cis RA/alpha toco) or observation for 12 months. Outcome measures are derived from histologic evaluation of bronchial biopsy specimens obtained by bronchoscopy at baseline and follow-up. The primary outcome measure is treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy. Seventy-five subjects were randomized (27/22/26 to observations/13-cis RA/13-cis RA/alpha toco); 59 completed the trial; 55 had both baseline and follow-up bronchoscopy. The risk of treatment failure was 55.6% (15 of 27) and 50% (24 of 48) in the observation and combined (13 cis RA plus 13 cis RA/alpha toco) treatment arms, respectively (odds ratio adjusted for baseline histology, 0.97; 95% confidence interval, 0.36-2.66; P = 0.95). Among subjects with complete histology data, maximum histology score in the observation arm increased by 0.37 units and by 0.03 units in the treated arms (difference adjusted for baseline, -0.18; 95% confidence interval, -1.16 to 0.81; P = 0.72). Similar (nonsignificant) results were observed for treatment effects on endobronchial proliferation as assessed by Ki-67 immunolabeling. Twelve-month treatment with 13-cis RA produced nonsignificant changes in bronchial histology, consistent with results in other trials. Agents advancing to phase III randomized trials should produce greater histologic changes. The

  15. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  16. Comprehensive study of observables in Compton scattering on the nucleon

    Science.gov (United States)

    Grießhammer, Harald W.; McGovern, Judith A.; Phillips, Daniel R.

    2018-03-01

    We present an analysis of 13 observables in Compton scattering on the proton. Cross sections, asymmetries with polarised beam and/or targets, and polarisation-transfer observables are investigated for energies up to the Δ(1232) resonance to determine their sensitivity to the proton's dipole scalar and spin polarisabilities. The Chiral Effective Field Theory Compton amplitude we use is complete at N4LO, O(e2δ4), for photon energies ω˜ m_{π}, and so has an accuracy of a few per cent there. At photon energies in the resonance region, it is complete at NLO, O(e2δ0), and so its accuracy there is about 20%. We find that for energies from pion-production threshold to about 250 MeV, multiple asymmetries have significant sensitivity to presently ill-determined combinations of proton spin polarisabilities. We also argue that the broad outcomes of this analysis will be replicated in complementary theoretical approaches, e.g., dispersion relations. Finally, we show that below the pion-production threshold, 6 observables suffice to reconstruct the Compton amplitude, and above it 11 are required. Although not necessary for polarisability extractions, this opens the possibility to perform "complete" Compton-scattering experiments. An interactive Mathematica notebook, including results for the neutron, is available from judith.mcgovern@manchester.ac.uk.

  17. The EMBARC European Bronchiectasis Registry: protocol for an international observational study

    Directory of Open Access Journals (Sweden)

    James D. Chalmers

    2016-01-01

    Full Text Available Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1 a clinical history consistent with bronchiectasis; and 2 computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1 bronchiectasis due to known cystic fibrosis; 2 age <18 years; and 3 patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials.

  18. MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Andreasson, Kate; Krogh, Jesper; Bech, Per; Frandsen, Hanne; Buus, Niels; Stanley, Barbara; Kerkhof, Ad; Nordentoft, Merete; Erlangsen, Annette

    2017-04-11

    Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper. The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion. A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning. ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016.

  19. The fate of prospective spine studies registered on www.ClinicalTrials.gov.

    Science.gov (United States)

    Ohnmeiss, Donna D

    2015-03-01

    There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by

  20. Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

    Science.gov (United States)

    Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

    2015-08-28

    Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

  1. Clinical Trials

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    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

  3. Mexican-American perspectives on participation in clinical trials: A qualitative study

    Directory of Open Access Journals (Sweden)

    Mariana Arevalo

    2016-12-01

    Full Text Available Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128 stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1 knowledge and understanding of clinical trials, 2 fears and concerns about participating, 3 perceived benefits of participating, and 4 incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.