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Douglas Altman

Jamie J Kirkham, Sarah Gorst, Douglas G Altman, Jane M Blazeby, Mike Clarke, Declan Devane, Elizabeth Gargon, David Moher, Jochen Schmitt, Peter Tugwell, Sean Tunis, Paula R Williamson
BACKGROUND: Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. METHODS AND FINDINGS: In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set-STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies...
October 2016: PLoS Medicine
Jonathan Ac Sterne, Miguel A Hernán, Barnaby C Reeves, Jelena Savović, Nancy D Berkman, Meera Viswanathan, David Henry, Douglas G Altman, Mohammed T Ansari, Isabelle Boutron, James R Carpenter, An-Wen Chan, Rachel Churchill, Jonathan J Deeks, Asbjørn Hróbjartsson, Jamie Kirkham, Peter Jüni, Yoon K Loke, Theresa D Pigott, Craig R Ramsay, Deborah Regidor, Hannah R Rothstein, Lakhbir Sandhu, Pasqualina L Santaguida, Holger J Schünemann, Beverly Shea, Ian Shrier, Peter Tugwell, Lucy Turner, Jeffrey C Valentine, Hugh Waddington, Elizabeth Waters, George A Wells, Penny F Whiting, Julian Pt Higgins
No abstract text is available yet for this article.
October 12, 2016: BMJ: British Medical Journal
Anna Lisa Crowley, Eric Yow, Huiman X Barnhart, Melissa A Daubert, Robert Bigelow, Daniel C Sullivan, Michael Pencina, Pamela S Douglas
BACKGROUND: There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results. METHODS: Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4)...
October 6, 2016: Journal of the American Society of Echocardiography
Ayodele Odutayo, Christopher X Wong, Allan J Hsiao, Sally Hopewell, Douglas G Altman, Connor A Emdin
OBJECTIVE: To quantify the association between atrial fibrillation and cardiovascular disease, renal disease, and death. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline and Embase. ELIGIBILITY CRITERIA: Cohort studies examining the association between atrial fibrillation and cardiovascular disease, renal disease, and death. Two reviewers independently extracted study characteristics and the relative risk of outcomes associated with atrial fibrillation: specifically, all cause mortality, cardiovascular mortality, major cardiovascular events, any stroke, ischaemic stroke, haemorrhagic stroke, ischaemic heart disease, sudden cardiac death, congestive heart failure, chronic kidney disease, and peripheral arterial disease...
September 6, 2016: BMJ: British Medical Journal
Andrew A Plumb, Claire Nickerson, Katherine Wooldrage, Paul Bassett, Stuart A Taylor, Douglas Altman, Wendy Atkin, Steve Halligan
BACKGROUND AND STUDY AIMS: Terminal digit preference bias for "pleasing" numbers has been described in many areas of medicine. The aim of this study was to determine whether endoscopists, radiologists, and pathologists exhibit such bias when measuring colorectal polyp diameters. METHODS: Colorectal polyp diameters measured at endoscopy, computed tomographic colonography (CTC), and histopathology were collated from a colorectal cancer screening program and two parallel multicenter randomized trials...
October 2016: Endoscopy
An-Wen Chan, Jennifer M Tetzlaff, Douglas G Altman, Andreas Laupacis, Peter C Gøtzsche, Karmela Krle A-Jerić, Asbjørn Hrobjartsson, Howard Mann, Kay Dickersin, Jesse A Berlin, Caroline J Dore, Wendy R Parulekar, William S M Summerskill, Trish Groves, Kenneth F Schulz, Harold C Sox, Frank W Rockhold, Drummond Rennie, David Moher
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format...
December 2015: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Eden Nohra, Sara Buckman, Kelly Bochicchio, Jad Chamieh, Stacey Reese, Corinne Merrill, Douglas Schuerer, Grant V Bochicchio
INTRODUCTION: Near-continuous glucose monitoring is expected to increase time in range (TIR) of 80-120mg/dL and to avoid hypoglycemia without increasing workload. We investigated a near-continuous glucose monitor in surgical critically ill and trauma patients. METHODS: Patients were enrolled at a surgical intensive care unit associated with a level 1 trauma center. Glucose measurements were compared to the gold standard Yellow Springs Instrument (YSI). The technology withdraws 0...
September 2016: Contemporary Clinical Trials
Douglas G Altman
No abstract text is available yet for this article.
July 5, 2016: Annals of Internal Medicine
David M Kent, Jason Nelson, Issa J Dahabreh, Peter M Rothwell, Douglas G Altman, Rodney A Hayward
BACKGROUND: Risk of the outcome is a mathematical determinant of the absolute treatment benefit of an intervention, yet this can vary substantially within a trial population, complicating the interpretation of trial results. METHODS: We developed risk models using Cox or logistic regression on a set of large publicly available randomized controlled trials (RCTs). We evaluated risk heterogeneity using the extreme quartile risk ratio (EQRR, the ratio of outcome rates in the lowest risk quartile to that in the highest) and skewness using the median to mean risk ratio (MMRR, the ratio of risk in the median risk patient to the average)...
July 3, 2016: International Journal of Epidemiology
Larissa Shamseer, Sally Hopewell, Douglas G Altman, David Moher, Kenneth F Schulz
BACKGROUND: The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community. This research aims to provide an update on the endorsement of CONSORT by high impact medical journals. METHODS: We performed a cross-sectional examination of the online "Instructions to Authors" of 168 high impact factor (2012) biomedical journals between July and December 2014...
2016: Trials
Ayodele Odutayo, Christopher X Wong, Michael Farkouh, Douglas G Altman, Sally Hopewell, Connor A Emdin, Benjamin H Hunn
AKI associates with increased long-term risk of mortality, but the prognostic significance of AKI in terms of long-term cardiovascular disease remains unconfirmed. We conducted a systematic review and meta-analysis to assess whether AKI associates with long-term cardiovascular disease. We included cohort studies that examined adults with and without AKI and reported a multivariable-adjusted relative risk (RR) for the association between AKI and cardiovascular mortality, major cardiovascular events, and disease-specific events: congestive heart failure, acute myocardial infarction, and stroke...
June 13, 2016: Journal of the American Society of Nephrology: JASN
Matthew J Page, Larissa Shamseer, Douglas G Altman, Jennifer Tetzlaff, Margaret Sampson, Andrea C Tricco, Ferrán Catalá-López, Lun Li, Emma K Reid, Rafael Sarkis-Onofre, David Moher
BACKGROUND: Systematic reviews (SRs) can help decision makers interpret the deluge of published biomedical literature. However, a SR may be of limited use if the methods used to conduct the SR are flawed, and reporting of the SR is incomplete. To our knowledge, since 2004 there has been no cross-sectional study of the prevalence, focus, and completeness of reporting of SRs across different specialties. Therefore, the aim of our study was to investigate the epidemiological and reporting characteristics of a more recent cross-section of SRs...
May 2016: PLoS Medicine
Sander Greenland, Stephen J Senn, Kenneth J Rothman, John B Carlin, Charles Poole, Steven N Goodman, Douglas G Altman
Misinterpretation and abuse of statistical tests, confidence intervals, and statistical power have been decried for decades, yet remain rampant. A key problem is that there are no interpretations of these concepts that are at once simple, intuitive, correct, and foolproof. Instead, correct use and interpretation of these statistics requires an attention to detail which seems to tax the patience of working scientists. This high cognitive demand has led to an epidemic of shortcut definitions and interpretations that are simply wrong, sometimes disastrously so-and yet these misinterpretations dominate much of the scientific literature...
April 2016: European Journal of Epidemiology
Gary S Collins, Emmanuel O Ogundimu, Jonathan A Cook, Yannick Le Manach, Douglas G Altman
Continuous predictors are routinely encountered when developing a prognostic model. Investigators, who are often non-statisticians, must decide how to handle continuous predictors in their models. Categorising continuous measurements into two or more categories has been widely discredited, yet is still frequently done because of its simplicity, investigator ignorance of the potential impact and of suitable alternatives, or to facilitate model uptake. We examine three broad approaches for handling continuous predictors on the performance of a prognostic model, including various methods of categorising predictors, modelling a linear relationship between the predictor and outcome and modelling a nonlinear relationship using fractional polynomials or restricted cubic splines...
October 15, 2016: Statistics in Medicine
Yuri Hosokawa, William M Adams, Rebecca L Stearns, Douglas J Casa
CONTEXT: It has been well established that gastrointestinal temperature (TGI) tracks closely with rectal temperature (TREC) during exercise. However, the field use of TGI pills is still being examined, and little is known about how measurements obtained using these devices compare during recovery after exercise in warm weather. OBJECTIVE: To compare TGI and TREC in runners who completed an 11.3-km warm-weather road race and determine if runners with higher TGI and TREC present with greater passive cooling rates during recovery...
May 2016: Journal of Athletic Training
Clément Lazarus, Romana Haneef, Philippe Ravaud, Sally Hopewell, Douglas G Altman, Isabelle Boutron
OBJECTIVE: To describe the impact of peer reviewers on spin in reports of non-randomized studies assessing a therapeutic intervention. DESIGN: Systematic review and retrospective before-after study. SAMPLE: Primary reports (n=128) published in BioMed Central Medical Series journals between January 1, 2011 and December 31, 2013. MAIN OUTCOME MEASURES: Number and type of spin examples identified, deleted or added by peer reviewers in the whole manuscript...
May 6, 2016: Journal of Clinical Epidemiology
Sander Greenland, Mohammad Ali Mansournia, Douglas G Altman
No abstract text is available yet for this article.
2016: BMJ: British Medical Journal
Umberto Benedetto, Douglas G Altman, Stephen Gerry, Alastair Gray, Belinda Lees, Rafal Pawlaczyk, Marcus Flather, David P Taggart
OBJECTIVES: The question of whether skeletonized internal thoracic artery harvesting reduces the incidence of sternal wound complications in comparison with the pedicled technique, in the context of single or bilateral internal thoracic arteries, remains controversial. We studied the impact of the internal thoracic artery harvesting strategy on sternal wound complication in the Arterial Revascularization Trial. METHODS: Patients enrolled in the Arterial Revascularization Trial (n = 3102) were randomized to coronary artery bypass grafting with single or bilateral internal thoracic arteries...
July 2016: Journal of Thoracic and Cardiovascular Surgery
Jennifer Weston, Kerry Dwan, Douglas Altman, Mike Clarke, Carrol Gamble, Sara Schroter, Paula Williamson, Jamie Kirkham
OBJECTIVES: Adding, omitting or changing prespecified outcomes can result in bias because it increases the potential for unacknowledged or post hoc revisions of the planned analyses. Journals have adopted initiatives such as requiring the prospective registration of trials and the submission of study protocols to promote the transparency of reporting in clinical trials. The main objective of this feasibility study was to document the frequency and types of outcome discrepancy between prespecified outcomes in the protocol and reported outcomes in trials submitted to The BMJ...
2016: BMJ Open
Dipak Kotecha, Luis Manzano, Henry Krum, Giuseppe Rosano, Jane Holmes, Douglas G Altman, Peter D Collins, Milton Packer, John Wikstrand, Andrew J S Coats, John G F Cleland, Paulus Kirchhof, Thomas G von Lueder, Alan S Rigby, Bert Andersson, Gregory Y H Lip, Dirk J van Veldhuisen, Marcelo C Shibata, Hans Wedel, Michael Böhm, Marcus D Flather
OBJECTIVES: To determine the efficacy and tolerability of β blockers in a broad age range of women and men with heart failure with reduced ejection fraction (HFrEF) by pooling individual patient data from placebo controlled randomised trials. DESIGN: Prospectively designed meta-analysis of individual patient data from patients aged 40-85 in sinus rhythm at baseline, with left ventricular ejection fraction <0.45. PARTICIPANTS: 13,833 patients from 11 trials; median age 64; 24% women...
2016: BMJ: British Medical Journal
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