Patient reported outcomes (PROs) in clinical trials : is 'in-trial' guidance lacking? a systematic review

Derek G Kyte; Heather Draper; Jonathan Ives; Clive Liles; Adrian Gheorghe; Melanie Calvert

doi:10.1371/journal.pone.0060684

Patient reported outcomes (PROs) in clinical trials : is 'in-trial' guidance lacking? a systematic review

Derek G Kyte, Heather Draper, Jonathan Ives, Clive Liles, Adrian Gheorghe, Melanie Calvert

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Abstract

Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas.

Original language	English
Article number	e60684
Journal	PLoS ONE
Volume	8
Issue number	4
DOIs	https://doi.org/10.1371/journal.pone.0060684
Publication status	Published - 1 Apr 2013

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10.1371/journal.pone.0060684

Kyte_Patient_reported_outcomes_PLOS_ONE_2013
Eligibility for repository : checked 31/03/2014
Final published version, 420 KBLicence: Creative Commons: Attribution (CC BY)

Linked to a/c DMAB.RRAK14731 Midland Hub for Trials Methodology Research at University of Birmingham
Billingham, L., Bryan, S., Calvert, M., Deeks, J., Delaney, B., Freemantle, N., Gray, R., Hobbs, R., Johnson, P., Lilford, R., Wheatley, K., Zeegers, M. & Wilson, S.
Medical Research Council
1/06/09 → 31/05/14
Project: Research Councils

Cite this

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Patient reported outcomes (PROs) in clinical trials : is 'in-trial' guidance lacking? a systematic review

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Linked to a/c DMAB.RRAK14731 Midland Hub for Trials Methodology Research at University of Birmingham

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