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Your search keyword '"Golub, Robert M"' showing total 2 results
Start Over Author "Golub, Robert M" Publisher escholarship, university of california
2 results on '"Golub, Robert M"'

1. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.

Author

Calvert, Melanie, King, Madeleine, Mercieca-Bebber, Rebecca, Aiyegbusi, Olalekan, Kyte, Derek, Slade, Anita, Chan, An-Wen, Basch, E, Bell, Jill, Bennett, Antonia, Bhatnagar, Vishal, Blazeby, Jane, Bottomley, Andrew, Brown, Julia, Brundage, Michael, Campbell, Lisa, Cappelleri, Joseph C, Draper, Heather, Dueck, Amylou C, Ells, Carolyn, Frank, Lori, Golub, Robert M, Griebsch, Ingolf, Haywood, Kirstie, Hunn, Amanda, King-Kallimanis, Bellinda, Martin, Laura, Mitchell, Sandra, Morel, Thomas, Nelson, Linda, Norquist, Josephine, O'Connor, Daniel, Palmer, Michael, Patrick, Donald, Price, Gary, Regnault, Antoine, Retzer, Ameeta, Revicki, Dennis, Scott, Jane, Stephens, Richard, Turner, Grace, Valakas, Antonia, Velikova, Galina, von Hildebrand, Maria, Walker, Anita, and Wenzel, Lari

Subjects
Humans, Research Design, Quality of Life, Checklist, Research Report, Patient Reported Outcome Measures, clinical trials, education & training, protocols & guidelines, statistics & research methods, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Published
2021

2. A call for transparent reporting to optimize the predictive value of preclinical research

Author

Landis, Story C, Amara, Susan G, Asadullah, Khusru, Austin, Chris P, Blumenstein, Robi, Bradley, Eileen W, Crystal, Ronald G, Darnell, Robert B, Ferrante, Robert J, Fillit, Howard, Finkelstein, Robert, Fisher, Marc, Gendelman, Howard E, Golub, Robert M, Goudreau, John L, Gross, Robert A, Gubitz, Amelie K, Hesterlee, Sharon E, Howells, David W, Huguenard, John, Kelner, Katrina, Koroshetz, Walter, Krainc, Dimitri, Lazic, Stanley E, Levine, Michael S, Macleod, Malcolm R, McCall, John M, Moxley III, Richard T, Narasimhan, Kalyani, Noble, Linda J, Perrin, Steve, Porter, John D, Steward, Oswald, Unger, Ellis, Utz, Ursula, and Silberberg, Shai D

Subjects
Accounting, Auditing and Accountability, Biomedical and Clinical Sciences, Commerce, Management, Tourism and Services, Animals, Publishing, Random Allocation, Research Design, Sample Size, Statistics as Topic, General Science & Technology
Abstract

The US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the methodological reporting of animal studies in grant applications and publications. The main workshop recommendation is that at a minimum studies should report on sample-size estimation, whether and how animals were randomized, whether investigators were blind to the treatment, and the handling of data. We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators, reviewers, funding agencies and journal editors. Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress.

Published
2012

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