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Douglas Altman

Katherine L Wright, Yun Jiang, Dan Ma, Douglas C Noll, Mark A Griswold, Vikas Gulani, Luis Hernandez-Garcia
In this study, the acquisition of ASL data and quantification of multiple hemodynamic parameters was explored using a Magnetic Resonance Fingerprinting (MRF) approach. A pseudo-continuous ASL labeling scheme was used with pseudo-randomized timings to acquire the MRF ASL data in a 2.5 min acquisition. A large dictionary of MRF ASL signals was generated by combining a wide range of physical and hemodynamic properties with the pseudo-random MRF ASL sequence and a two-compartment model. The acquired signals were matched to the dictionary to provide simultaneous quantification of cerebral blood flow, tissue time-to-peak, cerebral blood volume, arterial time-to-peak, B1 , and T1...
March 12, 2018: Magnetic Resonance Imaging
Einav Nachman, Peter Clemensen, Katheryn Santos, Alexis R Cole, Brian D Polizzotti, Grace Hofmann, Kristen T Leeman, Sarah J van den Bosch, John N Kheir
BACKGROUND: The accurate measurement of oxygen consumption (VO2) and energy expenditure (EE) may be helpful to optimize the treatment of critically ill patients. However, current techniques are limited in their ability to accurately quantify these end points in infants due to a low VO2, low tidal volume, and rapid respiratory rate. This study describes and validates a new device intended to perform in this size range. METHODS: We created a customized device that quantifies inspiratory volume using a pneumotachometer and concentrations of oxygen and carbon dioxide gas in the inspiratory and expiratory limbs...
March 1, 2018: Anesthesia and Analgesia
Umberto Benedetto, Douglas G Altman, Stephen Gerry, Alastair Gray, Belinda Lees, Gianni D Angelini, Marcus Flather, David P Taggart
BACKGROUND: There is still uncertainty about the safety of aprotinin for coronary artery bypass graft surgery. The ART (Arterial Revascularization Trial) was designed to compare survival after bilateral versus single internal thoracic artery grafting. Many of the ART patients (≈30%) received perioperative aprotinin. We investigated the association between perioperative aprotinin administration and short-term (in-hospital) and long-term outcomes by performing a post hoc analysis of the ART...
March 3, 2018: Journal of the American Heart Association
Mohammad Ali Mansournia, Douglas G Altman
No abstract text is available yet for this article.
February 22, 2018: BMJ: British Medical Journal
Angela MacCarthy, Shona Kirtley, Jennifer A de Beyer, Douglas G Altman, Iveta Simera
Many reports of health research omit important information needed to assess their methodological robustness and clinical relevance. Without clear and complete reporting, it is not possible to identify flaws or biases, reproduce successful interventions, or use the findings in systematic reviews or meta-analyses. The EQUATOR Network ( promotes responsible reporting and the use of reporting guidelines to improve the accuracy, completeness, and transparency of health research. EQUATOR supports researchers by providing online resources and training...
February 22, 2018: British Journal of Cancer
Katherine Davis, Sarah L Gorst, Nicola Harman, Valerie Smith, Elizabeth Gargon, Douglas G Altman, Jane M Blazeby, Mike Clarke, Sean Tunis, Paula R Williamson
BACKGROUND: Core outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process. METHODS: This review employed the same, multifaceted approach that was used in the original review and the previous two updates...
2018: PloS One
Aris T Papageorghiou, Stephen H Kennedy, Laurent J Salomon, Douglas G Altman, Eric O Ohuma, William Stones, Michael G Gravett, Fernando C Barros, Cesar Victora, Manorama Purwar, Yasmin Jaffer, Julia A Noble, Enrico Bertino, Ruyan Pang, Leila Cheikh Ismail, Ann Lambert, Zulfiqar A Bhutta, José Villar
The purpose of the INTERGROWTH-21st project was to develop international, prescriptive standards for fetal growth assessed by ultrasound and fundal height, preterm postnatal growth, newborn size and body composition, maternal weight gain, and infant development at the age of 2 years. Hence, we have produced, based on World Health Organization recommendations, the first comprehensive set of international standards of optimal fetal and newborn growth that perfectly match the existing World Health Organization child growth standards...
February 2018: American Journal of Obstetrics and Gynecology
Marlena V Habal, Kumaraswamy Nanthakumar, Peter C Austin, Cassandra Freitas, Christopher Labos, Douglas S Lee
BACKGROUND: Heart rate (HR) is a prognostic marker that is increasingly used as a therapeutic target in patients with cardiovascular disease. The association between resting and mean HR remains unclear. We therefore set out to determine the relationship between resting HR on the electrocardiogram (ECG) obtained at a single time point, and mean HR on implantable cardioverter defibrillator (ICD) interrogation amongst patients with a reduced left ventricular ejection fraction (LVEF). METHODS: Prospective ICD data were obtained from 54 patients with LVEF < 40%...
January 31, 2018: BMC Cardiovascular Disorders
Umberto Benedetto, Douglas G Altman, Stephen Gerry, Alastair Gray, Belinda Lees, Marcus Flather, David P Taggart
BACKGROUND: The long-term effects of off-pump coronary artery bypass continue to be controversial because some studies have reported increased adverse event rates with off-pump coronary artery bypass when compared with on-pump coronary artery bypass. The Arterial Revascularization Trial compared survival after bilateral versus single internal thoracic artery grafting. The choice of off-pump coronary artery bypass versus on-pump coronary artery bypass was based on the surgeon's discretion...
December 23, 2017: Journal of Thoracic and Cardiovascular Surgery
Matthew J Page, Isabelle Boutron, Camilla Hansen, Douglas G Altman, Asbjørn Hróbjartsson
Methods to assess risk of bias in a way that is reliable, reproducible and transparent to readers, have evolved over time. Viswanathan et al. recently provided updated recommendations for assessing risk of bias in systematic reviews of health care interventions. We comment on their recommendations, and discuss new tools in development that we, as co-convenors and coordinators of the Cochrane Bias Methods Group, are leading, which complement the methods recommended.
January 15, 2018: Journal of Clinical Epidemiology
Ellen R Copson, Tom C Maishman, Will J Tapper, Ramsey I Cutress, Stephanie Greville-Heygate, Douglas G Altman, Bryony Eccles, Sue Gerty, Lorraine T Durcan, Louise Jones, D Gareth Evans, Alastair M Thompson, Paul Pharoah, Douglas F Easton, Alison M Dunning, Andrew Hanby, Sunil Lakhani, Ros Eeles, Fiona J Gilbert, Hisham Hamed, Shirley Hodgson, Peter Simmonds, Louise Stanton, Diana M Eccles
BACKGROUND: Retrospective studies provide conflicting interpretations of the effect of inherited genetic factors on the prognosis of patients with breast cancer. The primary aim of this study was to determine the effect of a germline BRCA1 or BRCA2 mutation on breast cancer outcomes in patients with young-onset breast cancer. METHODS: We did a prospective cohort study of female patients recruited from 127 hospitals in the UK aged 40 years or younger at first diagnosis (by histological confirmation) of invasive breast cancer...
January 11, 2018: Lancet Oncology
Sally Hopewell, Claudia M Witt, Klaus Linde, Katja Icke, Olubusola Adedire, Shona Kirtley, Douglas G Altman
BACKGROUND: Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. METHODS: Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process...
January 11, 2018: Trials
José Villar, Leila Cheikh Ismail, Eleonora Staines Urias, Francesca Giuliani, Eric O Ohuma, Cesar G Victora, Aris T Papageorghiou, Douglas G Altman, Cutberto Garza, Fernando C Barros, Fabien Puglia, Roseline Ochieng, Yasmin A Jaffer, Julia A Noble, Enrico Bertino, Manorama Purwar, Ruyan Pang, Ann Lambert, Cameron Chumlea, Alan Stein, Michelle Fernandes, Zulfiqar A Bhutta, Stephen H Kennedy
BACKGROUND: The World Health Organization recommends that human growth should be monitored with the use of international standards. However, in obstetric practice, we continue to monitor fetal growth using numerous local charts or equations that are based on different populations for each body structure. Consistent with World Health Organization recommendations, the INTERGROWTH-21st Project has produced the first set of international standards to date pregnancies; to monitor fetal growth, estimated fetal weight, Doppler measures, and brain structures; to measure uterine growth, maternal nutrition, newborn infant size, and body composition; and to assess the postnatal growth of preterm babies...
December 19, 2017: American Journal of Obstetrics and Gynecology
Carrol Gamble, Ashma Krishan, Deborah Stocken, Steff Lewis, Edmund Juszczak, Caroline Doré, Paula R Williamson, Douglas G Altman, Alan Montgomery, Pilar Lim, Jesse Berlin, Stephen Senn, Simon Day, Yolanda Barbachano, Elizabeth Loder
Importance: While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Objective: To develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders. Design: Funders and regulators (n = 39) of randomized trials were contacted and the literature was searched to identify existing guidance; a survey of current practice was conducted across the network of UK Clinical Research Collaboration-registered trial units (n = 46, 1 unit had 2 responders) and a Delphi survey (n = 73 invited participants) was conducted to establish consensus on SAPs...
December 19, 2017: JAMA: the Journal of the American Medical Association
Michael F Harrison, Kathleen M Garcia, Ashot E Sargsyan, Douglas Ebert, Roy F Riascos-Castaneda, Scott A Dulchavsky
BACKGROUND: Back pain is a common complaint during spaceflight that is commonly attributed to intervertebral disc swelling in microgravity. Ultrasound (US) represents the only imaging modality on the International Space Station (ISS) to assess its etiology. The present study investigated: 1) The agreement and correlation of spinal US assessments as compared to results of pre- and postflight MRI studies; and 2) the trend in intervertebral disc characteristics over the course of spaceflight to ISS...
January 1, 2018: Aerospace Medicine and Human Performance
Matthew J Page, Douglas G Altman, Joanne E McKenzie, Larissa Shamseer, Nadera Ahmadzai, Dianna Wolfe, Fatemeh Yazdi, Ferrán Catalá-López, Andrea C Tricco, David Moher
OBJECTIVES: The objective of the study was to investigate the application and interpretation of statistical analyses in a cross-section of systematic reviews (SRs) of therapeutic interventions, without restriction by journal, clinical condition, or specialty. STUDY DESIGN AND SETTING: We evaluated a random sample of SRs assembled previously, which were indexed in MEDLINE® during February 2014, focused on a treatment or prevention question, and reported at least one meta-analysis...
March 2018: Journal of Clinical Epidemiology
Giulia Zumbo, Sharon V Barton, Douglas Thompson, Min Sun, Amna Abdel-Gadir, Thomas A Treibel, Daniel Knight, Ana Martinez-Naharro, Lane Thirusha, Julian D Gillmore, James C Moon, Philip N Hawkins, Marianna Fontana
BACKGROUND: Extracellular volume (ECV) by T1 mapping requires the contrast agent distribution to be at equilibrium. This can be achieved either definitively with a primed contrast infusion (infusion ECV), or sufficiently with a delay postbolus (bolus-only ECV). For large ECV, the bolus-only approach measures higher than the infusion ECV, causing some uncertainty in diseases such as amyloidosis. PURPOSE: To characterize the relationship between the bolus-only and current gold-standard infusion ECV in patients with amyloidosis...
November 21, 2017: Journal of Magnetic Resonance Imaging: JMRI
David Blanco, Jamie J Kirkham, Douglas G Altman, David Moher, Isabelle Boutron, Erik Cobo
INTRODUCTION: There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions...
November 16, 2017: BMJ Open
Jamie J Kirkham, Katherine Davis, Douglas G Altman, Jane M Blazeby, Mike Clarke, Sean Tunis, Paula R Williamson
BACKGROUND: The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR])...
November 2017: PLoS Medicine
Matthew J Page, Douglas G Altman, Larissa Shamseer, Joanne E McKenzie, Nadera Ahmadzai, Dianna Wolfe, Fatemeh Yazdi, Ferrán Catalá-López, Andrea C Tricco, David Moher
OBJECTIVES: To evaluate how often reproducible research practices, which allow others to recreate the findings of studies, given the original data, are used in systematic reviews (SRs) of biomedical research. STUDY DESIGN AND SETTING: We evaluated a random sample of SRs indexed in MEDLINE® during February 2014, which focused on a therapeutic intervention and reported at least one meta-analysis. Data on reproducible research practices in each SR were extracted using a 26-item form by one author, with a 20% random sample extracted in duplicate...
November 4, 2017: Journal of Clinical Epidemiology
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