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Find video protocols related to scientific articles indexed in Pubmed.
Impact of Spin in the Abstracts of Articles Reporting Results of Randomized Controlled Trials in the Field of Cancer: The SPIIN Randomized Controlled Trial.
J. Clin. Oncol.
PUBLISHED: 11-19-2014
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We aimed to assess the impact of spin (ie, reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results) on the interpretation of results of abstracts of randomized controlled trials (RCTs) in the field of cancer.
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Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies: The CHARMS Checklist.
PLoS Med.
PUBLISHED: 10-01-2014
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Carl Moons and colleagues provide a checklist and background explanation for critically appraising and extracting data from systematic reviews of prognostic and diagnostic prediction modelling studies. Please see later in the article for the Editors' Summary.
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Effects of on-pump and off-pump surgery in the Arterial Revascularization Trial.
Eur J Cardiothorac Surg
PUBLISHED: 09-14-2014
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The Arterial Revascularization Trial (ART) is a randomized comparison of bilateral internal mammary artery (BIMA) versus single internal mammary artery (SIMA) grafting in coronary artery bypass graft (CABG) surgery and is one of the largest randomized trials of surgery ever conducted. ART is also one of the largest studies of contemporary CABG with a high proportion of off-pump surgeries (41%). The objective of this post hoc analysis was to evaluate the surgical process and 1-year outcomes for surgery performed on-pump compared with off-pump.
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International standards for fetal growth based on serial ultrasound measurements: the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project.
Lancet
PUBLISHED: 09-12-2014
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In 2006, WHO produced international growth standards for infants and children up to age 5 years on the basis of recommendations from a WHO expert committee. Using the same methods and conceptual approach, the Fetal Growth Longitudinal Study (FGLS), part of the INTERGROWTH-21(st) Project, aimed to develop international growth and size standards for fetuses.
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Efficacy of ? blockers in patients with heart failure plus atrial fibrillation: an individual-patient data meta-analysis.
Lancet
PUBLISHED: 09-02-2014
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Atrial fibrillation and heart failure often coexist, causing substantial cardiovascular morbidity and mortality. ? blockers are indicated in patients with symptomatic heart failure with reduced ejection fraction; however, the efficacy of these drugs in patients with concomitant atrial fibrillation is uncertain. We therefore meta-analysed individual-patient data to assess the efficacy of ? blockers in patients with heart failure and sinus rhythm compared with atrial fibrillation.
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CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials.
Epidemiol Health
PUBLISHED: 08-23-2014
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The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. Randomized, controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions. However, randomized trials can yield biased results if they lack methodological rigor. To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information. That lack of adequate reporting fueled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 and its revision 5 years later. While those statements improved the reporting quality for some randomized, controlled trials, many trial reports still remain inadequate. Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organized a CONSORT Group meeting to update the 2001 statement. We introduce here the result of that process, CONSORT 2010.
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Association between analytic strategy and estimates of treatment outcomes in meta-analyses.
JAMA
PUBLISHED: 08-14-2014
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A persistent dilemma when performing meta-analyses is whether all available trials should be included in the meta-analysis.
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Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and elaboration.
Int J Surg
PUBLISHED: 07-22-2014
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Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www.strobe-statement.org/) should be helpful resources to improve reporting of observational research.
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The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies.
Int J Surg
PUBLISHED: 07-22-2014
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Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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Major geographical variations in elective coronary revascularization by stents or surgery in England.
Eur J Cardiothorac Surg
PUBLISHED: 07-19-2014
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Revascularization in stable coronary artery disease (CAD) can be achieved through percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) depending on the anatomical pattern of CAD, comorbidities and patient preference. Recent studies in the USA, Canada and Australia show marked local variation in the PCI/CABG ratio that is unexplained by patient-related factors. This current study assesses the geographical variation in elective coronary revascularization interventions across England and discusses its appropriateness.
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Scientific hypotheses can be tested by comparing the effects of one treatment over many diseases in a systematic review.
J Clin Epidemiol
PUBLISHED: 07-18-2014
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To describe the use of systematic reviews or overviews (systematic reviews of systematic reviews) to synthesize quantitative evidence of intervention effects across multiple indications (multiple-indication reviews) and to highlight issues pertaining to such reviews.
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Tracking Eye Gaze during Interpretation of Endoluminal Three-dimensional CT Colonography: Visual Perception of Experienced and Inexperienced Readers.
Radiology
PUBLISHED: 07-15-2014
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Purpose To identify and compare key stages of the visual process in experienced and inexperienced readers and to examine how these processes are used to search a moving three-dimensional (3D) image and their relationship to false-negative errors. Materials and Methods Institutional review board research ethics approval was granted to use anonymized computed tomographic (CT) colonographic data from previous studies and to obtain eye-tracking data from volunteers. Sixty-five radiologists (27 experienced, 38 inexperienced) interpreted 23 endoluminal 3D CT colonographic videos. Eye movements were recorded by using eye tracking with a desk-mounted tracker. Readers indicated when they saw a polyp by clicking a computer mouse. Polyp location and boundary on each video frame were quantified and gaze data were related to the polyp boundary for each individual reader and case. Predefined metrics were quantified and used to describe and compare visual search patterns between experienced and inexperienced readers by using multilevel modeling. Results Time to first pursuit was significantly shorter in experienced readers (hazard ratio, 1.22 [95% confidence interval: 1.04, 1.44]; P = .017) but other metrics were not significantly different. Regardless of expertise, metrics such as assessment, identification period, and pursuit times were extended in videos where polyps were visible on screen for longer periods of time. In 97% (760 of 787) of observations, readers correctly pursued polyps. Conclusion Experienced readers had shorter time to first eye pursuit, but many other characteristics of eye tracking were similar between experienced and inexperienced readers. Readers pursued polyps in 97% of observations, which indicated that errors during interpretation of 3D CT colonography in this study occurred in either the discovery or the recognition phase, but rarely in the scanning phase of radiologic image inspection. © RSNA, 2014.
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Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study.
BMJ
PUBLISHED: 07-03-2014
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To investigate the effectiveness of open peer review as a mechanism to improve the reporting of randomised trials published in biomedical journals.
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Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.
BMJ
PUBLISHED: 06-27-2014
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To assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines.
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Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach.
Circulation
PUBLISHED: 06-10-2014
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Although the potential survival benefit of bilateral internal mammary artery (BIMA) grafting in comparison with single internal mammary artery (SIMA) grafting has been emphasized by many investigators, the use of BIMA is still low in clinical practice in the absence of randomized trials and long-term results. In the current study, we aimed to assess if there is a long-term survival benefit of BIMA up to 10 years after coronary bypass surgery.
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Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials.
PLoS Med.
PUBLISHED: 06-01-2014
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Most publications about selective reporting in clinical trials have focussed on outcomes. However, selective reporting of analyses for a given outcome may also affect the validity of findings. If analyses are selected on the basis of the results, reporting bias may occur. The aims of this study were to review and summarise the evidence from empirical cohort studies that assessed discrepant or selective reporting of analyses in randomised controlled trials (RCTs).
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STRengthening Analytical Thinking for Observational Studies: the STRATOS initiative.
Stat Med
PUBLISHED: 05-28-2014
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The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodological developments are ignored in practice. Consequently, design and analysis of observational studies often exhibit serious weaknesses. The lack of guidance on vital practical issues discourages many applied researchers from using more sophisticated and possibly more appropriate methods when analyzing observational studies. Furthermore, many analyses are conducted by researchers with a relatively weak statistical background and limited experience in using statistical methodology and software. Consequently, even 'standard' analyses reported in the medical literature are often flawed, casting doubt on their results and conclusions. An efficient way to help researchers to keep up with recent methodological developments is to develop guidance documents that are spread to the research community at large. These observations led to the initiation of the strengthening analytical thinking for observational studies (STRATOS) initiative, a large collaboration of experts in many different areas of biostatistical research. The objective of STRATOS is to provide accessible and accurate guidance in the design and analysis of observational studies. The guidance is intended for applied statisticians and other data analysts with varying levels of statistical education, experience and interests. In this article, we introduce the STRATOS initiative and its main aims, present the need for guidance documents and outline the planned approach and progress so far. We encourage other biostatisticians to become involved. © 2014 The Authors. Statistics in Medicine published by John Wiley & Sons, Ltd.
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Detection of extracolonic pathologic findings with CT colonography: a discrete choice experiment of perceived benefits versus harms.
Radiology
PUBLISHED: 05-22-2014
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To determine the maximum rate of false-positive diagnoses that patients and health care professionals were willing to accept in exchange for detection of extracolonic malignancy by using computed tomographic (CT) colonography for colorectal cancer screening.
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Assessing methods to specify the target difference for a randomised controlled trial: DELTA (Difference ELicitation in TriAls) review.
Health Technol Assess
PUBLISHED: 05-09-2014
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The randomised controlled trial (RCT) is widely considered to be the gold standard study for comparing the effectiveness of health interventions. Central to the design and validity of a RCT is a calculation of the number of participants needed (the sample size). The value used to determine the sample size can be considered the 'target difference'. From both a scientific and an ethical standpoint, selecting an appropriate target difference is of crucial importance. Determination of the target difference, as opposed to statistical approaches to calculating the sample size, has been greatly neglected though a variety of approaches have been proposed the current state of the evidence is unclear.
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NY-ESO-1 specific antibody and cellular responses in melanoma patients primed with NY-ESO-1 protein in ISCOMATRIX and boosted with recombinant NY-ESO-1 fowlpox virus.
Int. J. Cancer
PUBLISHED: 05-05-2014
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Vaccination strategies based on repeated injections of NY-ESO-1 protein formulated in ISCOMATRIX particles (NY-ESO-1 ISCOMATRIX) have shown to elicit combined NY-ESO-1 specific antibody and T cell responses. However, it remains unclear whether heterologous prime-boost strategies based on the combination with NY-ESO-1 ISCOMATRIX with different NY-ESO-1 boosting reagents could be used to increase NY-ESO-1 CD8(+) or CD4(+) T cell responses. To address this question, we carried out a randomized clinical trial in 39 high-risk, resected melanoma patients vaccinated with NY-ESO-1 ISCOMATRIX, and then boosted with repeated injections of either recombinant fowlpox virus encoding full length NY-ESO-1 (rF-NY-ESO-1) (Arm A) or NY-ESO-1 ISCOMATRIX alone (Arm B). We have comprehensively analyzed NY-ESO-1 specific T cells and B cells response in all patients before and after vaccination for a total of seven time points per patient. NY-ESO-1 ISCOMATRIX alone elicited a strong NY-ESO-1 specific CD4(+) T cell and antibody response, which was maintained by both regiments at similar levels. However, CD8(+) T cell responses were significantly boosted in 3 out of 18 patients in Arm A after the first rF-NY-ESO-1 injection and such responses were maintained until the end of the trial, while no patients in Arm B showed similar CD8(+) T cell responses. In addition, our results clearly identified immunodominant regions in the NY-ESO-1 protein: NY-ESO-179-102 and NY-ESO-1115-138 for CD4+ T cells and NY-ESO-185-108 for CD8+ T cells in a large proportion of vaccinated patients. These regions of NY-ESO-1 protein should be considered in future clinical trials as immunodominant epitopes.
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Methods for specifying the target difference in a randomised controlled trial: the Difference ELicitation in TriAls (DELTA) systematic review.
PLoS Med.
PUBLISHED: 05-01-2014
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Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation.
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The COMET Initiative database: progress and activities from 2011 to 2013.
Trials
PUBLISHED: 03-12-2014
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The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database is an international repository of studies relevant to the development of core outcome sets. By the end of 2013, it included a unique collection of 306 studies. The website is increasingly being used, with more than 12,000 visits in 2013 (a 55% increase over 2012), 8,369 unique visitors (a 53% increase) and 6,844 new visitors (a 48% increase). There has been a rise in visits from outside the United Kingdom, with 2,405 such visits in 2013 (30% of all visits). By December 2013, a total of 4,205 searches had been completed, with 2,139 in 2013 alone.
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Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.
BMJ
PUBLISHED: 03-11-2014
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Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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Evaluation of the Cochrane Collaboration's tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation.
Syst Rev
PUBLISHED: 03-10-2014
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In 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials.
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External validation of multivariable prediction models: a systematic review of methodological conduct and reporting.
BMC Med Res Methodol
PUBLISHED: 03-03-2014
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Before considering whether to use a multivariable (diagnostic or prognostic) prediction model, it is essential that its performance be evaluated in data that were not used to develop the model (referred to as external validation). We critically appraised the methodological conduct and reporting of external validation studies of multivariable prediction models.
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Pragmatic trials can be designed as optimal medical care: principles and methods of care trials.
J Clin Epidemiol
PUBLISHED: 02-18-2014
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The way clinical research and care are currently separated encourages the practice of unverifiable medicine. Some pragmatic trials can be designed (1) to guide proper medical conduct in the presence of uncertainty and (2) to govern the distinction between unvalidated and validated care.
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Reducing waste from incomplete or unusable reports of biomedical research.
Lancet
PUBLISHED: 01-08-2014
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Research publication can both communicate and miscommunicate. Unless research is adequately reported, the time and resources invested in the conduct of research is wasted. Reporting guidelines such as CONSORT, STARD, PRISMA, and ARRIVE aim to improve the quality of research reports, but all are much less adopted and adhered to than they should be. Adequate reports of research should clearly describe which questions were addressed and why, what was done, what was shown, and what the findings mean. However, substantial failures occur in each of these elements. For example, studies of published trial reports showed that the poor description of interventions meant that 40-89% were non-replicable; comparisons of protocols with publications showed that most studies had at least one primary outcome changed, introduced, or omitted; and investigators of new trials rarely set their findings in the context of a systematic review, and cited a very small and biased selection of previous relevant trials. Although best documented in reports of controlled trials, inadequate reporting occurs in all types of studies-animal and other preclinical studies, diagnostic studies, epidemiological studies, clinical prediction research, surveys, and qualitative studies. In this report, and in the Series more generally, we point to a waste at all stages in medical research. Although a more nuanced understanding of the complex systems involved in the conduct, writing, and publication of research is desirable, some immediate action can be taken to improve the reporting of research. Evidence for some recommendations is clear: change the current system of research rewards and regulations to encourage better and more complete reporting, and fund the development and maintenance of infrastructure to support better reporting, linkage, and archiving of all elements of research. However, the high amount of waste also warrants future investment in the monitoring of and research into reporting of research, and active implementation of the findings to ensure that research reports better address the needs of the range of research users.
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Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository.
PLoS ONE
PUBLISHED: 01-01-2014
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Calls have been made for increased access to individual participant data (IPD) from clinical trials, to ensure that complete evidence is available. However, despite the obvious benefits, progress towards this is frustratingly slow. In the meantime, many systematic reviews have already collected IPD from clinical trials. We propose that a central repository for these IPD should be established to ensure that these datasets are safeguarded and made available for use by others, building on the strengths and advantages of the collaborative groups that have been brought together in developing the datasets.
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The quality of reporting methods and results in network meta-analyses: an overview of reviews and suggestions for improvement.
PLoS ONE
PUBLISHED: 01-01-2014
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Some have suggested the quality of reporting of network meta-analyses (a technique used to synthesize information to compare multiple interventions) is sub-optimal. We sought to review information addressing this claim.
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The CARE guidelines: consensus-based clinical case report guideline development.
J Diet Suppl
PUBLISHED: 11-19-2013
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A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Primary Objective: Develop, disseminate, and implement systematic reporting guidelines for case reports.
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The CARE guidelines: consensus-based clinical case reporting guideline development.
BMJ Case Rep
PUBLISHED: 10-25-2013
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A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery.
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The CARE Guidelines: Consensus-Based Clinical Case Reporting Guideline Development.
Headache
PUBLISHED: 09-16-2013
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A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.
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Identifying patients with undetected pancreatic cancer in primary care: an independent and external validation of QCancer(®) (Pancreas).
Br J Gen Pract
PUBLISHED: 09-04-2013
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Despite its rarity, the prognosis of pancreatic cancer is very poor and it is a major cause of cancer mortality; being ranked fourth in the world, it has one of the worst survival rates of any cancer.
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Estimation of gestational age in early pregnancy from crown-rump length when gestational age range is truncated: the case study of the INTERGROWTH-21st Project.
BMC Med Res Methodol
PUBLISHED: 09-02-2013
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Fetal ultrasound scanning is considered vital for routine antenatal care with first trimester scans recommended for accurate estimation of gestational age (GA). A reliable estimate of gestational age is key information underpinning clinical care and allows estimation of expected date of delivery. Fetal crown-rump length (CRL) is recommended over last menstrual period for estimating GA when measured in early pregnancy i.e. 9+0-13+6 weeks.
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Incorporation of assessments of risk of bias of primary studies in systematic reviews of randomised trials: a cross-sectional study.
BMJ Open
PUBLISHED: 08-27-2013
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We examined how assessments of risk of bias of primary studies are carried out and incorporated into the statistical analysis and overall findings of a systematic review.
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The CARE guidelines: consensus-based clinical case reporting guideline development.
Dtsch Arztebl Int
PUBLISHED: 08-13-2013
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A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Our primary objective was to develop, disseminate, and implement systematic reporting guidelines for case reports.
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Transparent reporting of trials is essential.
Am. J. Gastroenterol.
PUBLISHED: 08-06-2013
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Reports of randomized controlled trials (RCTs) inform the care of future patients and are especially important to clinicians and systematic reviewers. Readers should satisfy themselves that the study methods were sound. Clinicians should consider the relevance to their own patients, both benefits and harms, and absolute as well as relative effects. Trial reports should provide a clear, transparent, and complete report of what was done and what was found. Unfortunately, bad reporting of RCTs is common, which has serious consequences for clinical practice, research, policy making, and ultimately for patients. RCT reports should adhere to the CONSORT Statement, a minimum set of items that should be addressed. Authors, peer reviewers, and editors should all work to ensure that research reports maximize the value derived from the cost and effort of conducting a trial.
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The CARE guidelines: consensus-based clinical case report guideline development.
J Clin Epidemiol
PUBLISHED: 08-02-2013
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A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.
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The CARE guidelines: consensus-based clinical case reporting guideline development.
J Med Case Rep
PUBLISHED: 06-26-2013
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A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design.Primary Objective. Develop, disseminate, and implement systematic reporting guidelines for case reports.
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Prospective observational study of breast cancer treatment outcomes for UK women aged 18-40 years at diagnosis: the POSH study.
J. Natl. Cancer Inst.
PUBLISHED: 05-30-2013
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Breast cancer at a young age is associated with poor prognosis. The Prospective Study of Outcomes in Sporadic and Hereditary Breast Cancer (POSH) was designed to investigate factors affecting prognosis in this patient group.
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Meta-analysis and The Cochrane Collaboration: 20 years of the Cochrane Statistical Methods Group.
Syst Rev
PUBLISHED: 05-09-2013
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The Statistical Methods Group has played a pivotal role in The Cochrane Collaboration over the past 20 years. The Statistical Methods Group has determined the direction of statistical methods used within Cochrane reviews, developed guidance for these methods, provided training, and continued to discuss and consider new and controversial issues in meta-analysis. The contribution of Statistical Methods Group members to the meta-analysis literature has been extensive and has helped to shape the wider meta-analysis landscape.In this paper, marking the 20th anniversary of The Cochrane Collaboration, we reflect on the history of the Statistical Methods Group, beginning in 1993 with the identification of aspects of statistical synthesis for which consensus was lacking about the best approach. We highlight some landmark methodological developments that Statistical Methods Group members have contributed to in the field of meta-analysis. We discuss how the Group implements and disseminates statistical methods within The Cochrane Collaboration. Finally, we consider the importance of robust statistical methodology for Cochrane systematic reviews, note research gaps, and reflect on the challenges that the Statistical Methods Group faces in its future direction.
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PRISMA for Abstracts: reporting systematic reviews in journal and conference abstracts.
PLoS Med.
PUBLISHED: 04-01-2013
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Elaine Beller and colleagues from the PRISMA for Abstracts group provide a reporting guidelines for reporting abstracts of systematic reviews in journals and at conferences.
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Data sharing among data monitoring committees and responsibilities to patients and science.
Trials
PUBLISHED: 03-13-2013
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Over the past three decades it has become increasingly recognized that systematic assessment of as high a proportion as possible of relevant research evidence is needed to protect the best interests of patients and the public. For example, this principle is manifested in clinical guidelines and, increasingly, in the design and monitoring of new research. For scientific and ethical reasons, those responsible for monitoring the progress of ongoing clinical trials may need to seek unpublished and interim data to protect the interests of actual or potential participants in research. The challenge facing data monitoring committees has received relatively little attention, however. In this paper we review some of the commentaries on the issue and the few accounts of actual data monitoring committee experiences. We then present details of our own recent experience as members of the data monitoring committee for the BOOST-II UK trial (ISRCTN:0084226), one of five concurrent trials assessing the level of arterial oxygen which should be targeted in the care of very premature neonates. We conclude that efficient protection both of the interests of actual or potential participants in research and of science requires that data monitoring committees have access to all relevant research, including unpublished and interim data.
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Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review.
Trials
PUBLISHED: 03-11-2013
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For a randomized trial, the primary publication is usually the one which reports the results of the primary outcome and provides consolidated data from all study centers. Other aspects of a randomized trials findings (that is, non-primary results) are often reported in subsequent publications.
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Reliability and initial validation of the ulcerative colitis endoscopic index of severity.
Gastroenterology
PUBLISHED: 03-08-2013
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We studied the reliability of the previously described Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and validated it with an independent cohort of investigators.
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Patients & Healthcare Professionals Values Regarding True- & False-Positive Diagnosis when Colorectal Cancer Screening by CT Colonography: Discrete Choice Experiment.
PLoS ONE
PUBLISHED: 01-01-2013
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To establish the relative weighting given by patients and healthcare professionals to gains in diagnostic sensitivity versus loss of specificity when using CT colonography (CTC) for colorectal cancer screening.
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Five years of Trials.
Trials
PUBLISHED: 11-21-2011
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This editorial marks the launch of a special collection of articles highlighting Five years of Trials (http://www.trialsjournal.com/series/5years). The journals achievements on its objectives since 2006 are described and some of the challenges still ahead are outlined - in particular further innovating in the reporting of trials and the publication of negative results. The other articles in this series are examples of where Trials has demonstrated progress on its objectives. These include the publication of raw data, extended versions of previously published trial-related articles, descriptions of lessons learned, negative results, and educational articles regarding ethics and reporting bias.
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CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.
Int J Surg
PUBLISHED: 10-12-2011
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Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.
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Comparisons against baseline within randomised groups are often used and can be highly misleading.
Trials
PUBLISHED: 09-29-2011
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In randomised trials, rather than comparing randomised groups directly some researchers carry out a significance test comparing a baseline with a final measurement separately in each group.
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Reporting of participant flow diagrams in published reports of randomized trials.
Trials
PUBLISHED: 08-22-2011
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Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials.
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Predicting risk of osteoporotic and hip fracture in the United Kingdom: prospective independent and external validation of QFractureScores.
BMJ
PUBLISHED: 06-24-2011
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To evaluate the performance of the QFractureScores for predicting the 10 year risk of osteoporotic and hip fractures in an independent UK cohort of patients from general practice records.
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Systematic review: bias in imaging studies - the effect of manipulating clinical context, recall bias and reporting intensity.
Eur Radiol
PUBLISHED: 06-23-2011
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To perform a systematic review of diagnostic test accuracy studies which manipulate or investigate the context of interpretation. In particular, those which modify or conceal sample characteristics (e.g. disease prevalence or reporting intensity) or research setting ("laboratory" versus "field"). We also investigated recall bias.
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Prediction of moderate and high grade vesicoureteral reflux after a first febrile urinary tract infection in children: construction and internal validation of a clinical decision rule.
J. Urol.
PUBLISHED: 04-28-2011
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Urinary tract infection leads to a diagnosis of moderate or high grade (III or higher) vesicoureteral reflux in approximately 15% of children. Predicting reflux grade III or higher would make it possible to restrict cystography to high risk cases. We aimed to derive a clinical decision rule to predict vesicoureteral reflux grade III or higher in children with a first febrile urinary tract infection.
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Biomarker studies: a call for a comprehensive biomarker study registry.
Nat Rev Clin Oncol
PUBLISHED: 03-03-2011
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Tumor biomarker studies may generate insights into the biological characteristics that drive the clinical behavior of a cancer. Publication bias and hidden multiple hypotheses testing distort the assessment of the true value of biomarkers. Publication bias from preferential reporting of positive findings is well recognized. Hidden multihypothesis testing arises from several biomarkers being tested by different teams using the same samples. The more hypotheses (that is, biomarker association with outcome) tested, the greater the risk of false-positive findings. These biases inflate the potential clinical validity and utility of published biomarkers while negative results often remain hidden. Trial registries have been developed where all phase II and phase III trials should be listed regardless of study outcome. However, such steps have not been taken to reduce such bias in tumor biomarker research. We propose that a registry should be created for biomarker studies initially focused on studies that use specimens from randomized trials. Further development could include nonrandomized studies and deposition of raw data similar to existing genomic data repositories. The benefits of a comprehensive biomarker study registry include more balanced evaluation of proposed markers, fewer false positive leads in research, and hopefully more rapid identification of promising candidate biomarkers.
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Uses and misuses of the STROBE statement: bibliographic study.
BMJ Open
PUBLISHED: 02-26-2011
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Objectives Appropriate reporting is central to the application of findings from research to clinical practice. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations consist of a checklist of 22 items that provide guidance on the reporting of cohort, case-control and cross-sectional studies, in order to facilitate critical appraisal and interpretation of results. STROBE was published in October 2007 in several journals including The Lancet, BMJ, Annals of Internal Medicine and PLoS Medicine. Within the framework of the revision of the STROBE recommendations, the authors examined the context and circumstances in which the STROBE statement was used in the past. Design The authors searched the Web of Science database in August 2010 for articles which cited STROBE and examined a random sample of 100 articles using a standardised, piloted data extraction form. The use of STROBE in observational studies and systematic reviews (including meta-analyses) was classified as appropriate or inappropriate. The use of STROBE to guide the reporting of observational studies was considered appropriate. Inappropriate uses included the use of STROBE as a tool to assess the methodological quality of studies or as a guideline on how to design and conduct studies. Results The authors identified 640 articles that cited STROBE. In the random sample of 100 articles, about half were observational studies (32%) or systematic reviews (19%). Comments, editorials and letters accounted for 15%, methodological articles for 8%, and recommendations and narrative reviews for 26% of articles. Of the 32 observational studies, 26 (81%) made appropriate use of STROBE, and three uses (10%) were considered inappropriate. Among 19 systematic reviews, 10 (53%) used STROBE inappropriately as a tool to assess study quality. Conclusions The STROBE reporting recommendations are frequently used inappropriately in systematic reviews and meta-analyses as an instrument to assess the methodological quality of observational studies.
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Resources for authors of reports of randomized trials: harnessing the wisdom of authors, editors, and readers.
Trials
PUBLISHED: 02-04-2011
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The CONSORT Statement was developed to help authors improve the quality of reporting randomized trials. To augment the statement we published the CONSORT explanation and elaboration paper which included at least one example of good reporting for each CONSORT checklist item. We are developing a comprehensive database of examples of good reporting for each checklist item to take advantage of the breadth and variety of trials familiar to authors and readers globally. We invite authors, editors, and readers worldwide to nominate examples of well reported items for the database.
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Incremental benefit of computer-aided detection when used as a second and concurrent reader of CT colonographic data: multiobserver study.
Radiology
PUBLISHED: 11-17-2010
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To quantify the changes in reader performance levels, if any, during interpretation of computed tomographic (CT) colonographic data when a computer-aided detection (CAD) system is used as a second or concurrent reader.
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Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.
J Altern Complement Med
PUBLISHED: 10-20-2010
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The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
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Use of the Internet by print medical journals in 2003 to 2009: a longitudinal observational study.
Ann Emerg Med
PUBLISHED: 09-16-2010
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To determine how a sample of medical journals use the Internet to provide additional content and features to readers and how this has changed since 2003.
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[Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement (Chinese version)].
Zhong Xi Yi Jie He Xue Bao
PUBLISHED: 09-15-2010
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The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
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Randomized trial to compare bilateral vs. single internal mammary coronary artery bypass grafting: 1-year results of the Arterial Revascularisation Trial (ART).
Eur. Heart J.
PUBLISHED: 08-30-2010
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Observational data suggest that the use of bilateral internal mammary arteries (BIMA) during coronary artery bypass graft surgery provides superior revascularization to a single internal mammary artery (SIMA), but concerns about safety have prevented the widespread use of BIMA. The Arterial Revascularisation Trial (ART) is a randomized trial of BIMA vs. SIMA, with a primary outcome of survival at 10 years. This paper reports mortality, morbidity, and resource use data at 1 year.
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Visualizing and assessing discrimination in the logistic regression model.
Stat Med
PUBLISHED: 07-20-2010
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Logistic regression models are widely used in medicine for predicting patient outcome (prognosis) and constructing diagnostic tests (diagnosis). Multivariable logistic models yield an (approximately) continuous risk score, a transformation of which gives the estimated event probability for an individual. A key aspect of model performance is discrimination, that is, the models ability to distinguish between patients who have (or will have) an event of interest and those who do not (or will not). Graphical aids are important in understanding a logistic model. The receiver-operating characteristic (ROC) curve is familiar, but not necessarily easy to interpret. We advocate a simple graphic that provides further insight into discrimination, namely a histogram or dot plot of the risk score in the outcome groups. The most popular performance measure for the logistic model is the c-index, numerically equivalent to the area under the ROC curve. We discuss the comparative merits of the c-index and the (standardized) mean difference in risk score between the outcome groups. The latter statistic, sometimes known generically as the effect size, has been computed in slightly different ways by several different authors, including Glass, Cohen and Hedges. An alternative measure is the overlap between the distributions in the outcome groups, defined as the area under the minimum of the two density functions. The larger the overlap, the weaker the discrimination. Under certain assumptions about the distribution of the risk score, the c-index, effect size and overlap are functionally related. We illustrate the ideas with simulated and real data sets.
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Small study effects in meta-analyses of osteoarthritis trials: meta-epidemiological study.
BMJ
PUBLISHED: 07-20-2010
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To examine the presence and extent of small study effects in clinical osteoarthritis research.
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[CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)].
Zhong Xi Yi Jie He Xue Bao
PUBLISHED: 07-13-2010
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The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
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Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.
Acupunct Med
PUBLISHED: 06-08-2010
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The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word controlled in STRICTA is replaced by clinical, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
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Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes.
JAMA
PUBLISHED: 05-27-2010
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Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.
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An independent and external validation of QRISK2 cardiovascular disease risk score: a prospective open cohort study.
BMJ
PUBLISHED: 05-15-2010
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To evaluate the performance of the QRISK2 score for predicting 10-year cardiovascular disease in an independent UK cohort of patients from general practice records and to compare it with the NICE version of the Framingham equation and QRISK1.
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What is Visualize?

JoVE Visualize is a tool created to match the last 5 years of PubMed publications to methods in JoVE's video library.

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We use abstracts found on PubMed and match them to JoVE videos to create a list of 10 to 30 related methods videos.

Video X seems to be unrelated to Abstract Y...

In developing our video relationships, we compare around 5 million PubMed articles to our library of over 4,500 methods videos. In some cases the language used in the PubMed abstracts makes matching that content to a JoVE video difficult. In other cases, there happens not to be any content in our video library that is relevant to the topic of a given abstract. In these cases, our algorithms are trying their best to display videos with relevant content, which can sometimes result in matched videos with only a slight relation.