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https://www.readbyqxmd.com/read/28645203/neurosurgical-randomized-controlled-trials-distance-travelled
#1
Tej D Azad, Anand Veeravagu, Vaishali Mittal, Rogelio Esparza, Eli Johnson, John P A Ioannidis, Gerald A Grant
BACKGROUND: The evidence base for many neurosurgical procedures has been limited. We performed a comprehensive and systematic analysis of study design, quality of reporting, and trial results of neurosurgical randomized controlled trials (RCTs). OBJECTIVE: To systematically assess the design and quality characteristics of neurosurgical RCTs. METHODS: From January 1961 to June 2016, RCTs with >5 patients assessing any 1 neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library...
June 21, 2017: Neurosurgery
https://www.readbyqxmd.com/read/28632861/nonreproducibility-of-preclinical-research-reply
#2
John P A Ioannidis
No abstract text is available yet for this article.
June 20, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28611196/atf3-repression-of-bcl-xl-determines-apoptotic-sensitivity-tohdac-inhibitors-across-tumour-types
#3
Anderly C Chüeh, Janson Wt Tse, Michael Dickinson, Paul Ioannidis, Laura Jenkins, Lars Tögel, BeeShin Tan, Ian Luk, Mercedes Dávalos-Salas, Rebecca Nightingale, Matthew R Thompson, Bryan Rg Williams, Guillaume Lessene, Erinna F Lee, Walter D Fairlie, Amardeep S Dhillon, John M Mariadason
Purpose: Histone deacetylase inhibitors (HDACi) are epigenome-targeting small molecules approved for the treatment of cutaneous T cell lymphoma and multiple myeloma. They have also demonstrated clinical activity in AML, non-small cell lung cancer and estrogen receptor-positive breast cancer, and trials are underway assessing their activity in combination regimens including immunotherpy.  However, there is currently no clear strategy to reliably predict HDACi sensitivity. <p>In colon cancer cells, apoptotic sensitivity to HDACi is associated with transcriptional induction of multiple immediate-early (IE) genes...
June 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28589600/timing-and-characteristics-of-cumulative-evidence-available-on-novel-therapeutic-agents-receiving-food-and-drug-administration-accelerated-approval
#4
Huseyin Naci, Olivier J Wouters, Radhika Gupta, John P A Ioannidis
Policy Points: Randomized trials-the gold standard of evaluating effectiveness-constitute a small minority of existing evidence on agents given accelerated approval. One-third of randomized trials are in therapeutic areas outside of FDA approval and less than half evaluate the therapeutic benefits of these agents but use them instead as common backbone treatments. Agents receiving accelerated approval are often tested concurrently in several therapeutic areas. For most agents, no substantial time lag is apparent between the average start dates of randomized trials evaluating their effectiveness and those using them as part of background therapies...
June 2017: Milbank Quarterly
https://www.readbyqxmd.com/read/28532614/evidence-based-medicine-was-bound-to-fail-a-report-to-alvan-feinstein
#5
Giovanni A Fava
John Ioannidis has provided a lucid account, in the form of a report to David Sackett, of how evidence-based medicine (EBM) was hijacked to serve vested interests: major randomized controlled trials are largely done by and for the benefit of the industry; meta-analyses and guidelines are flooded with conflicts of interest; national and federal research funds are unable to address basic clinical questions. Nonetheless, EBM would remain a worthwhile goal. In this paper, in the form of a report to Alvan Feinstein, it is argued that current developments were largely predictable...
April 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28532611/hijacked-evidence-based-medicine-stay-the-course-and-throw-the-pirates-overboard
#6
John P A Ioannidis
The article discusses a number of criticisms that have been raised against evidence-based medicine, such as focusing on benefits and ignoring adverse events; being interested in averages and ignoring the wide variability in individual risks and responsiveness; ignoring clinician-patient interaction and clinical judgement; leading to some sort of reductionism; and falling prey to corruption from conflicts of interest. I argue that none of these deficiencies are necessarily inherent to evidence-based medicine...
April 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28521375/a-genetic-marker-associated-with-shoulder-dislocation
#7
Stuart Kim, John P Kleimeyer, Marwa A Ahmed, Andy L Avins, Michael Fredericson, Jason L Dragoo, John P A Ioannidis
Shoulder dislocations are common shoulder injuries associated with athletic activity in contact sports, such as football, rugby, wrestling, and hockey. Identifying genetic loci associated with shoulder dislocation could shed light on underlying mechanisms for injury and identify predictive genetic markers. To identify DNA polymorphisms associated with shoulder dislocation, a genome-wide association screen was performed using publically available data from the Research Program in Genes, Environment and Health including 662 cases of shoulder dislocation and 82 602 controls from the European ancestry group...
May 18, 2017: International Journal of Sports Medicine
https://www.readbyqxmd.com/read/28482362/two-genetic-loci-associated-with-medial-collateral-ligament-injury
#8
Andrew K Roos, Andy L Avins, Marwa A Ahmed, John P Kleimeyer, Thomas R Roos, Michael Fredericson, John P A Ioannidis, Jason L Dragoo, Stuart Kim
Medial collateral ligament (MCL) injuries are a common knee injury, especially in competitive athletes. Identifying genetic loci associated with MCL injury could shed light on its etiology. A genome-wide association screen was performed using data from the Research Program in Genes, Environment and Health (RPGEH) including 1 572 cases of MCL injury and 100 931 controls. 2 SNPs (rs80351309 and rs6083471) showed an association with MCL injury at genome-wide significance (p<5×10(-8)) with moderate effects (odds ratios=2...
May 8, 2017: International Journal of Sports Medicine
https://www.readbyqxmd.com/read/28459974/defending-biomedical-science-in-an-era-of-threatened-funding
#9
John P A Ioannidis
No abstract text is available yet for this article.
May 1, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28445470/the-credibility-crisis-in-research-can-economics-tools-help
#10
Thomas Gall, John P A Ioannidis, Zacharias Maniadis
The issue of nonreplicable evidence has attracted considerable attention across biomedical and other sciences. This concern is accompanied by an increasing interest in reforming research incentives and practices. How to optimally perform these reforms is a scientific problem in itself, and economics has several scientific methods that can help evaluate research reforms. Here, we review these methods and show their potential. Prominent among them are mathematical modeling and laboratory experiments that constitute affordable ways to approximate the effects of policies with wide-ranging implications...
April 2017: PLoS Biology
https://www.readbyqxmd.com/read/28435099/a-meta-analysis-but-not-a-systematic-review-an-evaluation-of-the-global-bmi-mortality-collaboration
#11
Katherine M Flegal, John P A Ioannidis
Meta-analyses of individual participant data (MIPDs) offer many advantages and are considered the highest level of evidence. However, MIPDs can be seriously compromised when they are not solidly founded upon a systematic review. These data-intensive collaborative projects may be led by experts who already have deep knowledge of the literature in the field and of the results of published studies and how these results vary based on different analytical approaches. If investigators tailor the searches, eligibility criteria and analysis plan of the MIPD, they run the risk of reaching foregone conclusions...
April 20, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28419203/selective-cutoff-reporting-in-studies-of-diagnostic-test-accuracy-a-comparison-of-conventional-and-individual-patient-data-meta-analyses-of-the-patient-health-questionnaire-9-depression-screening-tool
#12
Brooke Levis, Andrea Benedetti, Alexander W Levis, John P A Ioannidis, Ian Shrier, Pim Cuijpers, Simon Gilbody, Lorie A Kloda, Dean McMillan, Scott B Patten, Russell J Steele, Roy C Ziegelstein, Charles H Bombardier, Flavia de Lima Osório, Jesse R Fann, Dwenda Gjerdingen, Femke Lamers, Manote Lotrakul, Sonia R Loureiro, Bernd Löwe, Juwita Shaaban, Lesley Stafford, Henk C P M van Weert, Mary A Whooley, Linda S Williams, Karin A Wittkampf, Albert S Yeung, Brett D Thombs
In studies of diagnostic test accuracy, authors sometimes report results only for a range of cutoff points around data-driven "optimal" cutoffs. We assessed selective cutoff reporting in studies of the diagnostic accuracy of the Patient Health Questionnaire-9 (PHQ-9) depression screening tool. We compared conventional meta-analysis of published results only with individual-patient-data meta-analysis of results derived from all cutoff points, using data from 13 of 16 studies published during 2004-2009 that were included in a published conventional meta-analysis...
May 15, 2017: American Journal of Epidemiology
https://www.readbyqxmd.com/read/28411080/a-meta-analysis-of-individual-participant-data-constructed-to-align-with-prior-expert-views-comments-on-bhupathiraju-et%C3%A2-al
#13
Katherine M Flegal, John P A Ioannidis
No abstract text is available yet for this article.
April 12, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/28358823/genome-wide-association-screens-for-achilles-tendon-and-acl-tears-and-tendinopathy
#14
Stuart K Kim, Thomas R Roos, Andrew K Roos, John P Kleimeyer, Marwa A Ahmed, Gabrielle T Goodlin, Michael Fredericson, John P A Ioannidis, Andrew L Avins, Jason L Dragoo
Achilles tendinopathy or rupture and anterior cruciate ligament (ACL) rupture are substantial injuries affecting athletes, associated with delayed recovery or inability to return to competition. To identify genetic markers that might be used to predict risk for these injuries, we performed genome-wide association screens for these injuries using data from the Genetic Epidemiology Research on Adult Health and Aging (GERA) cohort consisting of 102,979 individuals. We did not find any single nucleotide polymorphisms (SNPs) associated with either of these injuries with a p-value that was genome-wide significant (p<5x10-8)...
2017: PloS One
https://www.readbyqxmd.com/read/28321561/ethics-and-epistemology-in-big-data-research
#15
Wendy Lipworth, Paul H Mason, Ian Kerridge, John P A Ioannidis
Biomedical innovation and translation are increasingly emphasizing research using "big data." The hope is that big data methods will both speed up research and make its results more applicable to "real-world" patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, and data analysis techniques...
March 20, 2017: Journal of Bioethical Inquiry
https://www.readbyqxmd.com/read/28320937/meta-assessment-of-bias-in-science
#16
Daniele Fanelli, Rodrigo Costas, John P A Ioannidis
Numerous biases are believed to affect the scientific literature, but their actual prevalence across disciplines is unknown. To gain a comprehensive picture of the potential imprint of bias in science, we probed for the most commonly postulated bias-related patterns and risk factors, in a large random sample of meta-analyses taken from all disciplines. The magnitude of these biases varied widely across fields and was overall relatively small. However, we consistently observed a significant risk of small, early, and highly cited studies to overestimate effects and of studies not published in peer-reviewed journals to underestimate them...
April 4, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28306144/exclusion-of-elderly-people-from-randomized-clinical-trials-of-drugs-for-ischemic-heart-disease
#17
Florence T Bourgeois, Liat Orenstein, Sarita Ballakur, Kenneth D Mandl, John P A Ioannidis
OBJECTIVES: To measure exclusion of elderly adults from randomized trials studying drug interventions for ischemic heart disease (IHD) and describe the characteristics of these trials. DESIGN: Cross-sectional analysis. SETTING: Interventional clinical trials studying a drug intervention for IHD that started in 2006 and after were identified in ClinicalTrials.gov. Data were extracted on study features, including age-based inclusion criteria...
March 17, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28298413/the-reproducibility-wars-successful-unsuccessful-uninterpretable-exact-conceptual-triangulated-contested-replication
#18
John P A Ioannidis
No abstract text is available yet for this article.
March 15, 2017: Clinical Chemistry
https://www.readbyqxmd.com/read/28282371/increasing-efficiency-of-preclinical-research-by-group-sequential-designs
#19
Konrad Neumann, Ulrike Grittner, Sophie K Piper, Andre Rex, Oscar Florez-Vargas, George Karystianis, Alice Schneider, Ian Wellwood, Bob Siegerink, John P A Ioannidis, Jonathan Kimmelman, Ulrich Dirnagl
Despite the potential benefits of sequential designs, studies evaluating treatments or experimental manipulations in preclinical experimental biomedicine almost exclusively use classical block designs. Our aim with this article is to bring the existing methodology of group sequential designs to the attention of researchers in the preclinical field and to clearly illustrate its potential utility. Group sequential designs can offer higher efficiency than traditional methods and are increasingly used in clinical trials...
March 2017: PLoS Biology
https://www.readbyqxmd.com/read/28273140/a-simulation-study-of-the-strength-of-evidence-in-the-recommendation-of-medications-based-on-two-trials-with-statistically-significant-results
#20
Don van Ravenzwaaij, John P A Ioannidis
A typical rule that has been used for the endorsement of new medications by the Food and Drug Administration is to have two trials, each convincing on its own, demonstrating effectiveness. "Convincing" may be subjectively interpreted, but the use of p-values and the focus on statistical significance (in particular with p < .05 being coined significant) is pervasive in clinical research. Therefore, in this paper, we calculate with simulations what it means to have exactly two trials, each with p < .05, in terms of the actual strength of evidence quantified by Bayes factors...
2017: PloS One
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