Research conducted into this question relating to the ClinicalTrials.gov database and the International Clinical Trials Registry Platform will be reported.
This document summarizes work to develop an improved search filter to more rapidly identify reports of randomized controlled trials (RCTs) in Embase for inclusion in the Cochrane Central Register of Controlled Trials (CENTRAL). Methods included developing and validating a sensitive search filter using reference sets of known RCTs. The updated 2015 filter identified RCTs with over 97.6% sensitivity compared to the previous Cochrane filter. Future work includes exploring text mining and crowdsourcing to further improve identification of RCTs for inclusion in CENTRAL.
Methods Pyramids as an Organizing Structure for Evidence-Based Medicine--SIGC...jodischneider
Keynote talk 2020-08-01 for the JCDL Workshop on Conceptual Models: https://sig-cm.github.io/news/JCDL-2020-CFP/
Discussion points:
* Methods are a key part of the Knowledge Organizing Structure for Evidence-Based Medicine.
* Methods relate to how we GENERATE evidence.
* Different methods generate evidence of different kinds and strength.
* I believe Methods can be useful in mining claims and arguments from papers: methods AUTHORIZE claims.
* More specialized hierarchies of evidence can be found in medicine
* Various groups are complicating the “evidence pyramid” hierarchy of evidence.
Continued citation of bad science and what we can do about it--2021-04-20jodischneider
Continued Citation of Bad Science and What We Can Do About It
Even papers that falsify data continue to be cited. I describe network and text analysis for studying how authors continue to cite bad science: articles retracted from the literature due to serious flaws or errors. I will present an in-depth case study of a human trial cited for over 10 years after it was retracted for falsifying data. Then, I will describe how the team scaled up to study a data set of 7000 retracted papers and hundreds of thousands of citations. Finally, I will discuss an ongoing Sloan-funded stakeholder consultation that is bringing editors, publishers, librarians, researchers, and research integrity experts together to address this problem.
BiographyJodi Schneider is Assistant Professor at the School of Information Sciences, University of Illinois at Urbana-Champaign where she runs the Information Quality Lab. She studies the science of science through the lens of arguments, evidence, and persuasion with a special interest in controversies in science. Her recent work has focused on topics such as systematic review automation, semantic publication, and the citation of retracted papers. Interdisciplinarity (PhD in Informatics, MS Library & Information Science, MA Mathematics; BA Great Books/liberal arts) is a fundamental principle of her work. She has held research positions across the U.S. as well as in Ireland, England, France, and Chile. She leads the Alfred P. Sloan-funded project, Reducing the Inadvertent Spread of Retracted Science: Shaping a Research and Implementation Agenda. With Aaron Cohen and Neil Smalheiser she is working on the NIH R01 "Text Mining Pipeline to Accelerate Systematic Reviews in Evidence-Based Medicine". Talk with her about scoping reviews and about citation-based methods for updating systematic reviews!
Tuesday, April 20th, 2021
Noon-1PM Eastern
GWU - CNHS Informatics Seminar
Are laboratory tests always needed frequency and causes of laboratory overu...Hossamaldin Alzawawi
This study analyzed laboratory test utilization in a hospital setting to identify overuse and underuse. The results showed that 20.6% of tests were overused while 44.8% were underused. Staff surveys found a lack of awareness around appropriate test ordering. Critical care had the highest canceled test reordering rate while outpatients had the lowest. The discussion concluded more education is needed for clinicians on test selection and utilizing laboratory physicians for consultations could improve practices and reduce errors. Limitations included the single-center design. In summary, this study evaluated laboratory test utilization, identified areas for improvement, and suggested strategies involving laboratory physicians could enhance appropriateness and patient safety.
COCHRANE OVERVIEW AND PRISMA STATEMENTKanhu Charan
1. The meta-analysis found that concomitant chemoradiotherapy improved overall survival compared to sequential chemoradiotherapy for locally advanced non-small cell lung cancer, due to better locoregional control, though it increased acute esophageal toxicity.
2. Temozolomide improved survival and delayed progression compared to radiotherapy alone for glioblastoma, but increased early adverse events. For recurrent glioblastoma, temozolomide improved time to progression over standard chemotherapy.
3. Surgery for early cervical adenocarcinoma showed a benefit over radiotherapy in one RCT, but most operated patients required adjuvant radiotherapy with greater morbidity compared to chemoradiation.
Beyond Randomized Clinical Trials: emerging innovations in reasoning about he...jodischneider
Talk at the 3rd European Conference on Argumentation
ABSTRACT: Specialized fields may at any time invent new inference rules—that is, new warrants—to improve on their stock of resources for drawing and defending conclusions. Yet disagreement over the acceptability of an invented warrant can always be re-opened. Randomized Clinical Trial is widely regarded as the gold standard for making inferences about causal relationships between medical treatments and patient outcomes. Once controversial, RCT achieved broad acceptance within the field as a result of warrant-establishing arguments circulating in the medical literature starting in the 1950s. And RCT has accumulated a very impressive track record of generating new conclusions that withstand critical scrutiny.
Here we look at two emerging innovations whose purpose is to support reasoning about health, offering ways to generate different classes of conclusions. These innovations could be seen as complementary to RCTs, but for both there are also hints of challenge to the enormous prestige of RCTs. We see this most particularly in the gap that has developed between the RCT-generated fact base and the decisions doctors and health policy officials have to make about treatments for patients. We’ve mentioned before that specialized inference methods that become stabilized within an expert community can meet unexpected challenges when they become components of reasoning by other communities. The two innovations considered here each allow us to explore the tensions that arise from the contrasting perspectives of scientists, clinicians, and patients.
The Cochrane Library is a collection of databases that provides high-quality, systematic reviews of the effects of healthcare interventions. It contains the Cochrane Database of Systematic Reviews, which summarizes conclusions about the effectiveness of interventions based on empirical evidence. Cochrane Reviews are considered the gold standard for systematic reviews because they are conducted to the highest methodological quality and updated regularly. The Cochrane Library also includes databases of controlled trials, reviews of other systematic reviews, methodology research, and economic evaluations to inform evidence-based healthcare decisions.
This document summarizes key points from a presentation on improving the quality of systematic reviews. It discusses issues like selective reporting of outcomes, non-publication of reviews, lack of registration, and the need for funders to improve reporting guidelines and develop templates for reviews. It also presents results from studies showing most reviews are not updated and estimating the time needed to update reviews is around 5 years. Surveys found many organizations see updating as important but few have formal policies for it.
This document summarizes work to develop an improved search filter to more rapidly identify reports of randomized controlled trials (RCTs) in Embase for inclusion in the Cochrane Central Register of Controlled Trials (CENTRAL). Methods included developing and validating a sensitive search filter using reference sets of known RCTs. The updated 2015 filter identified RCTs with over 97.6% sensitivity compared to the previous Cochrane filter. Future work includes exploring text mining and crowdsourcing to further improve identification of RCTs for inclusion in CENTRAL.
Methods Pyramids as an Organizing Structure for Evidence-Based Medicine--SIGC...jodischneider
Keynote talk 2020-08-01 for the JCDL Workshop on Conceptual Models: https://sig-cm.github.io/news/JCDL-2020-CFP/
Discussion points:
* Methods are a key part of the Knowledge Organizing Structure for Evidence-Based Medicine.
* Methods relate to how we GENERATE evidence.
* Different methods generate evidence of different kinds and strength.
* I believe Methods can be useful in mining claims and arguments from papers: methods AUTHORIZE claims.
* More specialized hierarchies of evidence can be found in medicine
* Various groups are complicating the “evidence pyramid” hierarchy of evidence.
Continued citation of bad science and what we can do about it--2021-04-20jodischneider
Continued Citation of Bad Science and What We Can Do About It
Even papers that falsify data continue to be cited. I describe network and text analysis for studying how authors continue to cite bad science: articles retracted from the literature due to serious flaws or errors. I will present an in-depth case study of a human trial cited for over 10 years after it was retracted for falsifying data. Then, I will describe how the team scaled up to study a data set of 7000 retracted papers and hundreds of thousands of citations. Finally, I will discuss an ongoing Sloan-funded stakeholder consultation that is bringing editors, publishers, librarians, researchers, and research integrity experts together to address this problem.
BiographyJodi Schneider is Assistant Professor at the School of Information Sciences, University of Illinois at Urbana-Champaign where she runs the Information Quality Lab. She studies the science of science through the lens of arguments, evidence, and persuasion with a special interest in controversies in science. Her recent work has focused on topics such as systematic review automation, semantic publication, and the citation of retracted papers. Interdisciplinarity (PhD in Informatics, MS Library & Information Science, MA Mathematics; BA Great Books/liberal arts) is a fundamental principle of her work. She has held research positions across the U.S. as well as in Ireland, England, France, and Chile. She leads the Alfred P. Sloan-funded project, Reducing the Inadvertent Spread of Retracted Science: Shaping a Research and Implementation Agenda. With Aaron Cohen and Neil Smalheiser she is working on the NIH R01 "Text Mining Pipeline to Accelerate Systematic Reviews in Evidence-Based Medicine". Talk with her about scoping reviews and about citation-based methods for updating systematic reviews!
Tuesday, April 20th, 2021
Noon-1PM Eastern
GWU - CNHS Informatics Seminar
Are laboratory tests always needed frequency and causes of laboratory overu...Hossamaldin Alzawawi
This study analyzed laboratory test utilization in a hospital setting to identify overuse and underuse. The results showed that 20.6% of tests were overused while 44.8% were underused. Staff surveys found a lack of awareness around appropriate test ordering. Critical care had the highest canceled test reordering rate while outpatients had the lowest. The discussion concluded more education is needed for clinicians on test selection and utilizing laboratory physicians for consultations could improve practices and reduce errors. Limitations included the single-center design. In summary, this study evaluated laboratory test utilization, identified areas for improvement, and suggested strategies involving laboratory physicians could enhance appropriateness and patient safety.
COCHRANE OVERVIEW AND PRISMA STATEMENTKanhu Charan
1. The meta-analysis found that concomitant chemoradiotherapy improved overall survival compared to sequential chemoradiotherapy for locally advanced non-small cell lung cancer, due to better locoregional control, though it increased acute esophageal toxicity.
2. Temozolomide improved survival and delayed progression compared to radiotherapy alone for glioblastoma, but increased early adverse events. For recurrent glioblastoma, temozolomide improved time to progression over standard chemotherapy.
3. Surgery for early cervical adenocarcinoma showed a benefit over radiotherapy in one RCT, but most operated patients required adjuvant radiotherapy with greater morbidity compared to chemoradiation.
Beyond Randomized Clinical Trials: emerging innovations in reasoning about he...jodischneider
Talk at the 3rd European Conference on Argumentation
ABSTRACT: Specialized fields may at any time invent new inference rules—that is, new warrants—to improve on their stock of resources for drawing and defending conclusions. Yet disagreement over the acceptability of an invented warrant can always be re-opened. Randomized Clinical Trial is widely regarded as the gold standard for making inferences about causal relationships between medical treatments and patient outcomes. Once controversial, RCT achieved broad acceptance within the field as a result of warrant-establishing arguments circulating in the medical literature starting in the 1950s. And RCT has accumulated a very impressive track record of generating new conclusions that withstand critical scrutiny.
Here we look at two emerging innovations whose purpose is to support reasoning about health, offering ways to generate different classes of conclusions. These innovations could be seen as complementary to RCTs, but for both there are also hints of challenge to the enormous prestige of RCTs. We see this most particularly in the gap that has developed between the RCT-generated fact base and the decisions doctors and health policy officials have to make about treatments for patients. We’ve mentioned before that specialized inference methods that become stabilized within an expert community can meet unexpected challenges when they become components of reasoning by other communities. The two innovations considered here each allow us to explore the tensions that arise from the contrasting perspectives of scientists, clinicians, and patients.
The Cochrane Library is a collection of databases that provides high-quality, systematic reviews of the effects of healthcare interventions. It contains the Cochrane Database of Systematic Reviews, which summarizes conclusions about the effectiveness of interventions based on empirical evidence. Cochrane Reviews are considered the gold standard for systematic reviews because they are conducted to the highest methodological quality and updated regularly. The Cochrane Library also includes databases of controlled trials, reviews of other systematic reviews, methodology research, and economic evaluations to inform evidence-based healthcare decisions.
This document summarizes key points from a presentation on improving the quality of systematic reviews. It discusses issues like selective reporting of outcomes, non-publication of reviews, lack of registration, and the need for funders to improve reporting guidelines and develop templates for reviews. It also presents results from studies showing most reviews are not updated and estimating the time needed to update reviews is around 5 years. Surveys found many organizations see updating as important but few have formal policies for it.
Continued citation of bad science and what we can do about it--2021-02-19jodischneider
Title: Continued Citation of Bad Science and What We Can Do About It
Abstract: Even papers that falsify data continue to be cited. I describe network and text analysis for studying how authors continue to cite bad science: articles retracted from the literature due to serious flaws or errors. Jodi will present an in-depth case study of a human trial cited for over 10 years after it was retracted for falsifying data. Then, will describe how the team scaled up to study a data set of 7000 retracted papers and hundreds of thousands of citations. Finally, Jodi will discuss an ongoing Sloan-funded stakeholder consultation that is bringing editors, publishers, librarians, researchers, and research integrity experts together to address this problem.
The document summarizes the Cochrane Database of Systematic Reviews, which contains over 3000 systematic reviews and 1700 protocols. The reviews primarily analyze randomized controlled trials to evaluate the effects of interventions in healthcare relating to prevention, treatment, rehabilitation, and more. The database includes reviews of alternative and natural treatments as well as English and non-English language trials.
This document discusses systematic reviews and meta-analyses. It provides information on Number Needed to Treat (NNT) and Number Needed to Harm (NNH). It also discusses how to set up a protocol for a systematic review, including determining study design, selection criteria, treatment arms and statistical considerations. The Cochrane Collaboration is mentioned as performing systematic reviews and meta-analyses to evaluate healthcare interventions.
The Data Citation Index indexes over 2.6 million data records and datasets from repositories across scientific fields. It contains over 400,000 citations to these records. However, 88% of the indexed resources remain uncited. Citations are more common for data studies than datasets. Certain fields like crystallography, biochemistry and molecular biology have higher than average citation rates for datasets. Sociology, demography and economics have higher citation rates for data studies. The authors note that data sharing could be lower than expected due to lack of recognition and incentives for researchers.
Lancaster design and analysis of pilot studiesnoorafifah
This document discusses recommendations for conducting pilot studies to plan randomized controlled trials (RCTs). It begins by reviewing literature on pilot studies and finding a lack of formal guidance on what constitutes a pilot study. The document then provides examples of objectives that could be addressed in an external pilot study to help plan an RCT, including: determining estimates needed to perform a sample size calculation for the larger trial; testing study protocols, data collection forms, and randomization procedures; and assessing recruitment and consent rates. Conducting pilot studies with clear objectives helps promote methodological rigor and leads to higher quality RCTs.
The cochrane library an introduction for rheumatologists - 17 feb 2014Tamara Rader
The Cochrane Library provides high-quality systematic reviews and other evidence to inform healthcare decisions. It contains six databases, including the Cochrane Database of Systematic Reviews which publishes Cochrane Reviews that synthesize medical studies. Cochrane Reviews follow a rigorous methodology to identify and analyze data from relevant studies to determine if interventions are effective. The goal is to provide reliable evidence to help patients, practitioners, and policymakers make informed choices about healthcare.
This document discusses clinical data publishing at Scientific Data. It describes how data descriptors for clinical studies have both human-readable and machine-readable components. It also notes that while clinical researchers generally support sharing clinical trial data, they have specific concerns about patient privacy. Examples of initiatives that enable controlled access to clinical data, like Yale Open Data Access, are provided. The document discusses Scientific Data's aim to identify repositories that can archive clinical data and facilitate specialist peer review while maintaining privacy. It also references guidance on publishing descriptions of non-public clinical datasets.
Clinical Research Informatics (CRI) Year-in-Review 2014Peter Embi
Peter Embi's review of notable publications and events in the field of Clinical Research Informatics (CRI) that took place in 2013+. This was presented as the closing keynote presentation of the 2014 AMIA CRI Summit in San Francisco, CA on April 11, 2014.
The document discusses Peter Embi's approach to presenting on clinical and translational research informatics literature from the past year. It provides an overview of Embi's search strategy and categorization of papers, which involved searching literature databases and recommendations from colleagues. The presentation will focus on summarizing representative papers within categories like data sharing/reuse, methods and systems, recruitment and eligibility, and trends in clinical research informatics.
Association between delayed initiation of adjuvant CMF or anthracycline-based...Enrique Moreno Gonzalez
Adjuvant chemotherapy (AC) improves survival among patients with operable breast cancer. However, the effect of delay in AC initiation on survival is unclear. We performed a systematic review and meta-analysis to determine the relationship between time to AC and
survival outcomes.
Open PHACTS Explorer demonstration and talk given at SWAT4LS, Edinburgh, 2013. The Explorer is an Ember JS MVC web application used to navigate the Open PHACTS Linked Data Cache without requiring any knowledge of RDF or SPARQL
Systematic reviews of topical fluorides for dental caries: a review of report...cathykr
This document summarizes a systematic review of 38 published systematic reviews and meta-analyses on the caries-preventive effects of topical fluoride therapies. It finds that while many reviews focused on fluoride toothpastes and children/adolescents, reporting of eligibility criteria, search methods, and risk of bias assessment was often inadequate. Future reviews should follow guidelines like PRISMA to improve validity and relevance through complete reporting of methods and results.
Automated weaning systems aim to improve adaptation of mechanical ventilation support based on continuous patient monitoring. This systematic review and meta-analysis evaluated 21 randomized controlled trials comparing automated weaning systems to non-automated weaning. Pooled results found that automated systems reduced the duration of mechanical ventilation by 10% and time spent in the intensive care unit by 8%. Automated systems also decreased weaning duration by 30%, with the greatest effect seen in mixed or medical intensive care unit populations and when using the Smartcare/PSTM system. There was no strong evidence of impact on mortality or hospital length of stay. Overall, automated weaning systems can reduce ventilation and intensive care unit times.
The Adapted ADAPTE approach to CPG adaptation proposed by the Alexandria Center for Evidence-Based Clinical Practice Guidelines, Alexandria University, Egypt.
An oral presentation conducted by Prof. Tarek Omar during the national initiative of the Pediatrics Department, Armed Forces College of Medicine, themed; 'Towards National Guidelines' that was launched in 2018 and started by Pediatrics CPGs
This document discusses statistical guidelines and considerations for clinical trials from various organizations. It provides an overview of how statistics are described in ICH, WHO, Malaysian, and European guidelines. Key points covered include the importance of pre-specifying the statistical analysis plan before a trial begins, considerations for study design such as randomization and blinding, determining sample size, evaluating safety data, and reporting trial results according to the pre-specified plan.
This document summarizes a presentation given by Peter Embi on clinical and translational research and informatics literature from 2012-2013. It begins with Embi's background and approach to identifying relevant papers. It then describes the topics covered in the presentation, which are grouped into categories like clinical data reuse, data management/discovery, researcher support/resources, and recruitment. For each category, 1-2 key papers are summarized in 1-3 sentences. The summaries highlight the papers' goals, methods, and conclusions. The document concludes by mentioning other notable papers and events from the past year.
Comparative efficacy of interventions to promote hand hygiene
in hospital: systematic review and network meta-analysis
Nantasit Luangasanatip,1, 2 Maliwan Hongsuwan,1 Direk Limmathurotsakul,1, 3 Yoel Lubell,1, 4
Andie S Lee,5, 6 Stephan Harbarth,5 Nicholas P J Day,1, 4 Nicholas Graves,2, 7 Ben S Cooper1, 4
This presentation discusses the FDA's Real-World Evidence Program and use of real-world data and evidence to support regulatory decisions. It provides definitions of key terms like real-world data and real-world evidence. Examples are given of drugs approved or indications expanded based on real-world evidence studies, including randomized trials generating real-world evidence. While randomized trials were traditionally preferred, a variety of observational study designs may also provide adequate evidence if fit-for-purpose and bias is adequately addressed.
Enhancing the quality and transparency of health research: Introducing the PR...Thomas Bandholm
This lecture was held September 14 in Aalborg, Denmark at a PhD Forum (symposium). I hope you find it useful. Kind regards Thomas Bandholm (Twitter@TBandholm).
Continued citation of bad science and what we can do about it--2021-02-19jodischneider
Title: Continued Citation of Bad Science and What We Can Do About It
Abstract: Even papers that falsify data continue to be cited. I describe network and text analysis for studying how authors continue to cite bad science: articles retracted from the literature due to serious flaws or errors. Jodi will present an in-depth case study of a human trial cited for over 10 years after it was retracted for falsifying data. Then, will describe how the team scaled up to study a data set of 7000 retracted papers and hundreds of thousands of citations. Finally, Jodi will discuss an ongoing Sloan-funded stakeholder consultation that is bringing editors, publishers, librarians, researchers, and research integrity experts together to address this problem.
The document summarizes the Cochrane Database of Systematic Reviews, which contains over 3000 systematic reviews and 1700 protocols. The reviews primarily analyze randomized controlled trials to evaluate the effects of interventions in healthcare relating to prevention, treatment, rehabilitation, and more. The database includes reviews of alternative and natural treatments as well as English and non-English language trials.
This document discusses systematic reviews and meta-analyses. It provides information on Number Needed to Treat (NNT) and Number Needed to Harm (NNH). It also discusses how to set up a protocol for a systematic review, including determining study design, selection criteria, treatment arms and statistical considerations. The Cochrane Collaboration is mentioned as performing systematic reviews and meta-analyses to evaluate healthcare interventions.
The Data Citation Index indexes over 2.6 million data records and datasets from repositories across scientific fields. It contains over 400,000 citations to these records. However, 88% of the indexed resources remain uncited. Citations are more common for data studies than datasets. Certain fields like crystallography, biochemistry and molecular biology have higher than average citation rates for datasets. Sociology, demography and economics have higher citation rates for data studies. The authors note that data sharing could be lower than expected due to lack of recognition and incentives for researchers.
Lancaster design and analysis of pilot studiesnoorafifah
This document discusses recommendations for conducting pilot studies to plan randomized controlled trials (RCTs). It begins by reviewing literature on pilot studies and finding a lack of formal guidance on what constitutes a pilot study. The document then provides examples of objectives that could be addressed in an external pilot study to help plan an RCT, including: determining estimates needed to perform a sample size calculation for the larger trial; testing study protocols, data collection forms, and randomization procedures; and assessing recruitment and consent rates. Conducting pilot studies with clear objectives helps promote methodological rigor and leads to higher quality RCTs.
The cochrane library an introduction for rheumatologists - 17 feb 2014Tamara Rader
The Cochrane Library provides high-quality systematic reviews and other evidence to inform healthcare decisions. It contains six databases, including the Cochrane Database of Systematic Reviews which publishes Cochrane Reviews that synthesize medical studies. Cochrane Reviews follow a rigorous methodology to identify and analyze data from relevant studies to determine if interventions are effective. The goal is to provide reliable evidence to help patients, practitioners, and policymakers make informed choices about healthcare.
This document discusses clinical data publishing at Scientific Data. It describes how data descriptors for clinical studies have both human-readable and machine-readable components. It also notes that while clinical researchers generally support sharing clinical trial data, they have specific concerns about patient privacy. Examples of initiatives that enable controlled access to clinical data, like Yale Open Data Access, are provided. The document discusses Scientific Data's aim to identify repositories that can archive clinical data and facilitate specialist peer review while maintaining privacy. It also references guidance on publishing descriptions of non-public clinical datasets.
Clinical Research Informatics (CRI) Year-in-Review 2014Peter Embi
Peter Embi's review of notable publications and events in the field of Clinical Research Informatics (CRI) that took place in 2013+. This was presented as the closing keynote presentation of the 2014 AMIA CRI Summit in San Francisco, CA on April 11, 2014.
The document discusses Peter Embi's approach to presenting on clinical and translational research informatics literature from the past year. It provides an overview of Embi's search strategy and categorization of papers, which involved searching literature databases and recommendations from colleagues. The presentation will focus on summarizing representative papers within categories like data sharing/reuse, methods and systems, recruitment and eligibility, and trends in clinical research informatics.
Association between delayed initiation of adjuvant CMF or anthracycline-based...Enrique Moreno Gonzalez
Adjuvant chemotherapy (AC) improves survival among patients with operable breast cancer. However, the effect of delay in AC initiation on survival is unclear. We performed a systematic review and meta-analysis to determine the relationship between time to AC and
survival outcomes.
Open PHACTS Explorer demonstration and talk given at SWAT4LS, Edinburgh, 2013. The Explorer is an Ember JS MVC web application used to navigate the Open PHACTS Linked Data Cache without requiring any knowledge of RDF or SPARQL
Systematic reviews of topical fluorides for dental caries: a review of report...cathykr
This document summarizes a systematic review of 38 published systematic reviews and meta-analyses on the caries-preventive effects of topical fluoride therapies. It finds that while many reviews focused on fluoride toothpastes and children/adolescents, reporting of eligibility criteria, search methods, and risk of bias assessment was often inadequate. Future reviews should follow guidelines like PRISMA to improve validity and relevance through complete reporting of methods and results.
Automated weaning systems aim to improve adaptation of mechanical ventilation support based on continuous patient monitoring. This systematic review and meta-analysis evaluated 21 randomized controlled trials comparing automated weaning systems to non-automated weaning. Pooled results found that automated systems reduced the duration of mechanical ventilation by 10% and time spent in the intensive care unit by 8%. Automated systems also decreased weaning duration by 30%, with the greatest effect seen in mixed or medical intensive care unit populations and when using the Smartcare/PSTM system. There was no strong evidence of impact on mortality or hospital length of stay. Overall, automated weaning systems can reduce ventilation and intensive care unit times.
The Adapted ADAPTE approach to CPG adaptation proposed by the Alexandria Center for Evidence-Based Clinical Practice Guidelines, Alexandria University, Egypt.
An oral presentation conducted by Prof. Tarek Omar during the national initiative of the Pediatrics Department, Armed Forces College of Medicine, themed; 'Towards National Guidelines' that was launched in 2018 and started by Pediatrics CPGs
This document discusses statistical guidelines and considerations for clinical trials from various organizations. It provides an overview of how statistics are described in ICH, WHO, Malaysian, and European guidelines. Key points covered include the importance of pre-specifying the statistical analysis plan before a trial begins, considerations for study design such as randomization and blinding, determining sample size, evaluating safety data, and reporting trial results according to the pre-specified plan.
This document summarizes a presentation given by Peter Embi on clinical and translational research and informatics literature from 2012-2013. It begins with Embi's background and approach to identifying relevant papers. It then describes the topics covered in the presentation, which are grouped into categories like clinical data reuse, data management/discovery, researcher support/resources, and recruitment. For each category, 1-2 key papers are summarized in 1-3 sentences. The summaries highlight the papers' goals, methods, and conclusions. The document concludes by mentioning other notable papers and events from the past year.
Comparative efficacy of interventions to promote hand hygiene
in hospital: systematic review and network meta-analysis
Nantasit Luangasanatip,1, 2 Maliwan Hongsuwan,1 Direk Limmathurotsakul,1, 3 Yoel Lubell,1, 4
Andie S Lee,5, 6 Stephan Harbarth,5 Nicholas P J Day,1, 4 Nicholas Graves,2, 7 Ben S Cooper1, 4
This presentation discusses the FDA's Real-World Evidence Program and use of real-world data and evidence to support regulatory decisions. It provides definitions of key terms like real-world data and real-world evidence. Examples are given of drugs approved or indications expanded based on real-world evidence studies, including randomized trials generating real-world evidence. While randomized trials were traditionally preferred, a variety of observational study designs may also provide adequate evidence if fit-for-purpose and bias is adequately addressed.
Enhancing the quality and transparency of health research: Introducing the PR...Thomas Bandholm
This lecture was held September 14 in Aalborg, Denmark at a PhD Forum (symposium). I hope you find it useful. Kind regards Thomas Bandholm (Twitter@TBandholm).
The State of Clinical Development - GlobalizationTTC, llc
The document discusses the increasing globalization of clinical trials. It notes that in 2010, ACRO member companies managed nearly 2 million participants in over 11,500 clinical trials across 114 countries. The companies employ over 72,000 people worldwide and were involved in developing many top-selling drugs. While globalization provides benefits like increased availability of patients and investigators, it also presents challenges regarding infrastructure, regulations, ethics, and data quality across regions. The document outlines recent and ongoing research by ACRO examining data quality and other factors across mature and emerging market regions.
Polit, D. & Beck, C. (2012). Nursing research Generating and asse.docxLeilaniPoolsy
Polit, D. & Beck, C. (2012). Nursing research: Generating and assessing evidence for nursing practice (9th ed.). Philidelphia, PA: Lippincott Williams & Wilkins
Polit, D. & Beck, C. (2012). Nursing research: Generating and assessing evidence for nursing practice (9th ed.). Philidelphia, PA: Lippincott Williams & Wilkins
p. 673
A type of mixed studies model is an integrated design (Sandelowski
et al., 2007), which can be used when qualitative
and quantitative findings in an area of inquiry are
perceived as able to confirm, extend, or refute each
other. In an integrated design, studies are grouped not
by method but by findings viewed as answering the
same research question. The analytic approach may
involve transforming the findings (qualitizing quantitative
findings or quantitizing qualitative findings) to
enable them to be combined. A particularly sophisticated
variant of this model is to use a Bayesian
synthesis, as exemplified in a study in which
p. 676
In drawing conclusions about a research synthesis,
a major issue concerns the nature of the decisions
the researcher made. Sampling decisions, approaches
to handling quality of the primary studies, and analytic
approaches should be carefully evaluated to
assess the soundness of the reviewers’ conclusions.
Another aspect, however, is drawing inferences about
how you might use the evidence in clinical practice.
Examples of critique:
Example 1: A Meta-Analysis
Study: Meta-analysis of quality-of-life outcomes from
physical activity interventions (Conn et al., 2009).
Purpose: The purpose of the meta-analysis was to integrate
research evidence on the effects of physical activity
(PA) on quality of life (QOL) outcomes among
adults with chronic illness. Two of the specific research
questions addressed were: (a) What is the overall mean
difference effect size (ES) in QOL scores between
treatment and control subjects after interventions to
increase PA? (b) Do the effects of PA interventions on
QOL outcomes vary depending on the characteristics
of participants, methodology, or interventions?
Eligibility Criteria: Criteria for study inclusion were
spelled out in Table 1 of the report, together with an
explicit rationale for each criterion. A study was
included if it examined the effects of a PA intervention
on QOL for people with a chronic illness and if it:
(a) was an English-language study, (b) was published
in a report after 1970, (c) involved a sample of at least
5 subjects, and (d) included measures designed
specifically to assess QOL (not, for example, QOLrelated
constructs such as mood). Both published and
unpublished reports were eligible, and diverse
research designs were permitted (not just RCTs).
Search Strategy: A reference librarian performed
searches, using well-specified search terms, in 11 databases
(e.g., MEDLINE, CINAHL, Dissertation
Abstracts, Scopus, PsycINFO). The National Institutes
of Health database of funded studies was also searched.
Ancestry searching was conducted, a.
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
This document discusses knowledge transfer between researchers and policymakers. It begins with an overview of the knowledge cycle and evidence-based healthcare. It notes that while researchers seek truth and policymakers seek compromise, their common goal is improving public health. The document recommends establishing units to facilitate knowledge transfer and decision support. It also suggests training policymakers to identify how research can help and accessing evidence to inform decisions. The overall message is that researchers and policymakers must understand each other and work together toward their shared goal of improving health outcomes.
This document discusses research methodology and how it can be applied to homeopathy. It defines different types of study designs including observational studies, treatment studies, randomized controlled trials, and meta-analyses. It explains how to apply these research methodologies to homeopathy through drug provings, clinical research studies, and disease-related studies while respecting homeopathic principles. Randomized controlled trials and meta-analyses are important for providing evidence but must be designed carefully to fit within homeopathic individualization and philosophy.
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Is it appropriate to limit searches to prospective trials registries? Research evidence
1. Is it appropriate to limit
searches to prospective
trials registries?
Research evidence
Julie Glanville
Associate Director, YHEC, University of York, York, UK
Co-Convenor, Cochrane IRMG
julie.glanville@york.ac.uk
Oct 2015
2. Overview
Report on pilot study and follow-up research undertaken
at York Health Economics Consortium
Can we rely on searches of trials registers to find all
relevant studies for assessment for a SR?
Acknowledgements:
– Karen Hall for initial ideas and involvement in the pilot study
– My co-authors: Steven Duffy, Rachael McCool and Danielle
Varley
3. Background
Trials registers are growing in number and currency
Legislation, journal editors, consumer pressure and other factors
are providing the impetus to increase prospective registration of
trials
Have we reached the stage where we can identify RCTs for reviews
from the registers alone?
Generated two questions:
Can we dispense with the bibliographic searches of databases such
as Medline and Embase?
Do we need to search both ClinicalTrials.gov and the ICTRP portal
to find trial records (given that the content of one is included in the
other)?
4. Research project
Pilot study with 2 recently updated Cochrane reviews
Larger study with 6 further reviews
5. Methods
Identify Gold
standard
• Identified eight recently updated Cochrane Reviews
• Identified included studies in those reviews which had matching trials
records in ICTRP and/or ClinicalTrials.gov
Test strategies
• Reran or adapted the systematic review search strategies to find the
identified studies in each register
• Tested different search approaches
Assess strategy
yield
• Identified yield of search approaches in ICTRP and/or
ClinicalTrials.gov
• Explored the value of using basic and advanced search options in
those registers
6. Identifying candidate SRs
Pilot study [2011]:
two recently updated systematic reviews from the
Cochrane Injuries Group
Larger study [2012]:
searching for ‘‘New’’ reviews in the 2012 issue 1
version of CDSR
7. Identifying records in trials
registers, 1
We used the following techniques to search ICTRP
and/or ClinicalTrials.gov to identify known trials
Trial number identifier
OR
Trial name/abbreviation
OR
Intervention (AND (geographical location OR date) where result
numbers were large)
OR
Author/lead investigator (AND (geographical location OR date)
where result numbers were large)
8. Identifying records in trials
registers, 2
To achieve geographical focus
‘‘Locations’’ field was used in ClinicalTrials.gov
“Countries of recruitment’’ option was used in ICTRP
If the included study was carried out in the United States
and the search results were large, the ‘‘State’’ location
limit in ClinicalTrials.gov was employed.
9. Results, selected SRs
Anti-fibrinolytic use for minimising perioperative allogeneic blood
transfusion
Preoperative autologous donation for minimising perioperative allogeneic
blood transfusion
Parenteral versus oral iron therapy for adults and children with chronic
kidney disease
Intracutaneous or subcutaneous sterile water injection compared with
blinded controls for pain management in labour
Intramedullary nailing for tibial shaft fractures in adults
Tranexamic acid for upper gastrointestinal bleeding
Intravesical gemcitabine for non-muscle invasive bladder cancer
Continuous glucose monitoring systems for type 1 diabetes mellitus
10. Results: study identification
Number
of
included
studies
included
studies
identified in
ClinicalTrials.
gov
included
studies
identified in
ICTRP
Number of
identified studies
not found in
either resource
Overlap
between
CT and
ICTRP
Henry 1 252 4 8 244 4
Henry 2 14 1 1 13 1
Albaramk
i
28 5 6 22 5
Derry 7 0 0 7 0
Duan 11 1 1 10 1
Gluud 7 0 0 7 0
Jones 6 2 2 4 2
Langend
am
22 8 12 10 8
Number of Included Studies Identified in the Trials Registers
11. Reviews varied in size from 6 to 252 included studies
30 of the 347 (8.6%) included studies were in one of the two
registers
2/8 reviews (both 7 studies) had no matching trial records in
either ClinicalTrials.gov or ICTRP
The percentage of included studies found in registers ranged
from 0% (2 reviews) to 54.5% (1 review)
Identified Studies
12. Trial age?
Was identification a feature of register age?
SR Example 1
18/22 of the studies in the SR were published after 2005 (so
might have been expected to be registered)
12/18 (66.6%) were identified in the registers
SR example 2
206 studies were published after 2005
8/206 (3.88%) were identified in the registers
13. Discussion
Matching included studies to register records
can be challenging
We may have missed a few
Trials registers are complementary to
bibliographic databases and help to
Fill the gaps
Provide results (and different views on results)
Provide access to trials which may never be formally
published
14. Other research, snapshots
Reveiz L (Colloquium 2011)
89/256 trials (16.9%) identified were registered in ICTRP
Stegeman I et al (Colloquium 2014)
“clinical trial registration is not yet adopted in otolarynchology”
Hardt J Ls (Colloquium 2013)
83% of relevant surgical RCTs were registered
Bhaumik et al (Colloquium 2015)
63/686 (9%) of trials reported in Indian journals were registered
Scherer (BMC Medical Res Methodology 2013)
154/496 (31%) ARVO abstracts had a trial register record
Odutayo A et al (Colloquium 2014)
560/1370 (40.9%) RCTs from Pubmed were reported as registered
15. Other research (snapshot)
Li (Colloquium 2012)
Japan, South Korea, Singapore, Hong Kong and Taiwan: all countries
had less than 30% of trials on Pubmed, registered
Hooft L et al (Colloquium 2011)
172 Dutch pediatric drug trials – 56% were registered prospectively.
Huser V & Cimino J J. JAMIA 2013;20(e1)
661/690 5 ICJME founding journals included the trial id
Gill C J. BMJ Open 2012; 2(4)
“This analysis indicates that compliance with registration of US-based
human subject research trials on CTG remains quite poor. ”
Kohler M et al. BMJ 2015 350:h796
15 IQWIG dossiers (up to 28 Feb 2013) containing 22 studies
A registry report in ClinicaTrials.gov was available for all studies
16. Summary
Clinicaltrials.gov and ICTRP
These are valuable major resources available to identify clinical
trials
The evidence from our research suggests that low proportions of
trials included in SRs have trial records, even when focusing on
more recent trials
We still need to search both bibliographic databases and trials
registers until we can be sure that trials are being prospectively
registered on the trials registers
Current evidence suggests we need to search both
ClinicalTrials.gov and ICTRP because of interface differences
17. Our publication
Glanville JM, Duffy S, McCool R, Varley D.
Searching ClinicalTrials.gov and the International
Clinical Trials Registry Platform to inform systematic
reviews: what are the optimal search approaches?
J Med Libr Assoc. 2014 Jul;102(3):177-83.
doi: 10.3163/1536-5050.102.3.007
18. Providing Consultancy &
Research in Health Economics
http://tinyurl.com/yhec-facebook
http://twitter.com/YHEC1
http://www.minerva-network.com/
http://tinyurl.com/YHEC-LinkedIn
Thank you
julie.glanville@york.ac.uk
Telephone: +44 1904 324832
Website: www.yhec.co.uk