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Tackling poorly selected, collected, and reported outcomes in obstetrics and gynecology research - 26/12/18

Doi : 10.1016/j.ajog.2018.09.023 
James M.N. Duffy, MBChB, MRes a, , Sue Ziebland, DPhil, MSc a, Peter von Dadelszen, FRCOG, DPhil b, Richard J. McManus, FRCGP, FRCP a
a Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom 
b Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom 

Corresponding author: Dr James M. N. Duffy, MBChB MRes BSc (Hons) PG HCL.

Abstract

Clinical research should ultimately improve patient care. To enable this, randomized controlled trials must select, collect, and report outcomes that are both relevant to clinical practice and genuinely reflect the perspectives of key stakeholders including health care professionals, researchers, and patients. Unfortunately, many randomized controlled trials fall short of this requirement. Complex issues, including a failure to take into account the perspectives of key stakeholders when selecting outcomes, variations in outcome definitions and measurement instruments, and outcome reporting bias make research evidence difficult to interpret, undermining the translation of research into clinical practice. Problems with poor outcome selection, measurement, and reporting can be addressed by developing, disseminating, and implementing core outcome sets. A core outcome set represents a minimum data set of outcomes developed using robust consensus science methods engaging diverse stakeholders including health care professionals, researchers, and patients. Core outcomes should be routinely utilized by researchers, collected in a standardized manner, and reported consistently in the final publication. They are currently being developed across our specialty including infertility, endometriosis, and preeclampsia. Recognizing poorly selected, collected, and reported outcomes as serious hindrances to progress in our specialty, more than 80 journals including the Journal, have come together to support the Core Outcomes in Women’s and Newborn Health (CROWN) initiative. The consortium supports researchers to develop, disseminate, and implement core outcome sets. Implementing core outcome sets could make a profound contribution to addressing poorly selected, collected, and reported outcomes. Implementation should ensure future randomized controlled trials hold the necessary reach and relevance to inform clinical practice, enhance patient care, and improve patient outcomes.

Il testo completo di questo articolo è disponibile in PDF.

Key words : core outcome sets, gynecology, obstetrics, outcome measures, outcomes, research waste


Mappa


 This report is arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. Dr McManus was supported by a National Institute for Health Research Professorship (NIHR-RP-R2-12-015) and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Oxford. Dr Ziebland is supported by a National Institute for Health Research Senior Investigator award. The funders had no role in the commentary.
 Dr Richard McManus has received blood pressure monitors for research from Omron. The other authors no conflict of interests.


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Vol 220 - N° 1

P. 71.e1-71.e4 - gennaio 2019 Ritorno al numero
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