Uptake of core outcome sets by clinical trialists publishing in major medical journals:  Protocol

Karen Matvienko-Sikar; Kerry N L Avery; Jane M Blazeby; Karen Hughes; Pamela Jacobson; Jamie Kirkham; Jan Kottner; Katie Mellor; Ian Saldanha; Valerie Smith; Caroline B Terwee; Paula R Williamson

doi:10.12688/hrbopenres.13109.1

Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol

Karen Matvienko-Sikar^*, Kerry N L Avery, Jane M Blazeby, Karen Hughes, Pamela Jacobson, Jamie Kirkham, Jan Kottner, Katie Mellor, Ian Saldanha, Valerie Smith, Caroline B Terwee, Paula R Williamson

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

50 Downloads (Pure)

Abstract

Background. Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area.

Methods. This study will examine late phase trials, published between January and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS.

Discussion. This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

Original language	English
Article number	53
Number of pages	7
Journal	HRB Open Research
Volume	3
Early online date	10 Oct 2020
DOIs	https://doi.org/10.12688/hrbopenres.13109.1
Publication status	E-pub ahead of print - 10 Oct 2020

Access to Document

10.12688/hrbopenres.13109.1

Full-text PDF (final published version)
This is the final published version of the article (version of record). It first appeared online via F1000Research at https://doi.org/10.12688/hrbopenres.13109.1 Please refer to any applicable terms of use of the publisher.
Final published version, 300 KBLicence: CC BY

Handle.net

Persistent link

Embargoed Document

Full-text PDF (author accepted manuscript)
Accepted author manuscript, 236 KB
Request copy

Cite this

@article{0f90d7196e96447c94d88714b9bcb5ed,

title = "Uptake of core outcome sets by clinical trialists publishing in major medical journals: Protocol",

abstract = "Background. Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods. This study will examine late phase trials, published between January and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists{\textquoteright} awareness of, and decisions to search for and use a COS.Discussion. This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.",

author = "Karen Matvienko-Sikar and Avery, {Kerry N L} and Blazeby, {Jane M} and Karen Hughes and Pamela Jacobson and Jamie Kirkham and Jan Kottner and Katie Mellor and Ian Saldanha and Valerie Smith and {B Terwee}, Caroline and Williamson, {Paula R}",

year = "2020",

month = oct,

day = "10",

doi = "10.12688/hrbopenres.13109.1",

language = "English",

volume = "3",

journal = "HRB Open Research",

issn = "2515-4826",

publisher = "F1000Research",

}

TY - JOUR

T1 - Uptake of core outcome sets by clinical trialists publishing in major medical journals

T2 - Protocol

AU - Matvienko-Sikar, Karen

AU - Avery, Kerry N L

AU - Blazeby, Jane M

AU - Hughes, Karen

AU - Jacobson, Pamela

AU - Kirkham, Jamie

AU - Kottner, Jan

AU - Mellor, Katie

AU - Saldanha, Ian

AU - Smith, Valerie

AU - B Terwee, Caroline

AU - Williamson, Paula R

PY - 2020/10/10

Y1 - 2020/10/10

N2 - Background. Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods. This study will examine late phase trials, published between January and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS.Discussion. This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

AB - Background. Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods. This study will examine late phase trials, published between January and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS.Discussion. This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

U2 - 10.12688/hrbopenres.13109.1

DO - 10.12688/hrbopenres.13109.1

M3 - Article (Academic Journal)

SN - 2515-4826

VL - 3

JO - HRB Open Research

JF - HRB Open Research

M1 - 53

ER -