Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children

Ian P. Sinha; Douglas G. Altman; Michael W Beresford; Maarten Boers; Mike Clarke; Jonathan Craig; Ornella Della Casa-Alberighi; Ricardo M. Fernandes; Lisa Hartling; Bradley C. Johnston; Andrew Lux; Amy Plint; Peter Tugwell; Mark Turner; Johanna H van der Lee; Martin Offringa; Paula R Williamson; Rosalind L. Smyth

doi:10.1542/peds.2012-0055H

Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children

Ian P. Sinha, Douglas G. Altman, Michael W Beresford, Maarten Boers, Mike Clarke, Jonathan Craig, Ornella Della Casa-Alberighi, Ricardo M. Fernandes, Lisa Hartling, Bradley C. Johnston, Andrew Lux, Amy Plint, Peter Tugwell, Mark Turner, Johanna H van der Lee, Martin Offringa, Paula R Williamson, Rosalind L. Smyth

Flinders University

Research output: Contribution to journal › Article › peer-review

58 Citations (Scopus)

Abstract

People making choices in health care should use the findings of clinical trials (ideally, incorporated in systematic reviews) to inform their decisions. If these findings are to be useful and reliable, researchers must select appropriate outcomes, measure them in a scientifically robust manner, and report results thoroughly. There are difficulties, however, relating to the selection and measurement of outcomes in clinical trials, and special considerations are needed when these studies are conducted in children.

This article provides guidance for researchers working on clinical trials in children. Although this article is focused on trials of effectiveness, which are similar to therapeutic confirmatory trials, certain sections may also relate to efficacy trials, pharmacokinetic trials, therapeutic exploratory trials, and trials conducted earlier in drug development.

Original language	English
Pages (from-to)	S146-S152
Number of pages	7
Journal	Pediatrics
Volume	129
Issue number	SUPPL. 3
DOIs	https://doi.org/10.1542/peds.2012-0055H
Publication status	Published - Jun 2012

Bibliographical note

This is the fifth in a series of standard articles resulting from an ongoing process in which a group of invited experts called a Standard Development Group from StaR Child Health assembles and exchanges information about methods for pediatric trial design, conduct, and reporting. More detailed information about this topic can be found in the introductory article of this supplement or at the StaR Child Health Web site (www.starchildhealth.org).

Keywords

health care
decision making
clinical trials
children
Pediatrics
Outcome measures
StaR child health
Outcome sets
Selective reporting

Access to Document

10.1542/peds.2012-0055HLicence: In Copyright

Cite this

Sinha, I. P., Altman, D. G., Beresford, M. W., Boers, M., Clarke, M., Craig, J., Della Casa-Alberighi, O., Fernandes, R. M., Hartling, L., Johnston, B. C., Lux, A., Plint, A., Tugwell, P., Turner, M., van der Lee, J. H., Offringa, M., Williamson, P. R., & Smyth, R. L. (2012). Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children. Pediatrics, 129(SUPPL. 3), S146-S152. https://doi.org/10.1542/peds.2012-0055H

@article{38b591576c1e465b864d39c2dba71dcd,

title = "Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children",

abstract = "People making choices in health care should use the findings of clinical trials (ideally, incorporated in systematic reviews) to inform their decisions. If these findings are to be useful and reliable, researchers must select appropriate outcomes, measure them in a scientifically robust manner, and report results thoroughly. There are difficulties, however, relating to the selection and measurement of outcomes in clinical trials, and special considerations are needed when these studies are conducted in children.This article provides guidance for researchers working on clinical trials in children. Although this article is focused on trials of effectiveness, which are similar to therapeutic confirmatory trials, certain sections may also relate to efficacy trials, pharmacokinetic trials, therapeutic exploratory trials, and trials conducted earlier in drug development.",

keywords = "health care, decision making, clinical trials, children, Pediatrics, Outcome measures, StaR child health, Outcome sets, Selective reporting",

author = "Sinha, {Ian P.} and Altman, {Douglas G.} and Beresford, {Michael W} and Maarten Boers and Mike Clarke and Jonathan Craig and {Della Casa-Alberighi}, Ornella and Fernandes, {Ricardo M.} and Lisa Hartling and Johnston, {Bradley C.} and Andrew Lux and Amy Plint and Peter Tugwell and Mark Turner and {van der Lee}, {Johanna H} and Martin Offringa and Williamson, {Paula R} and Smyth, {Rosalind L.}",

note = "This is the fifth in a series of standard articles resulting from an ongoing process in which a group of invited experts called a Standard Development Group from StaR Child Health assembles and exchanges information about methods for pediatric trial design, conduct, and reporting. More detailed information about this topic can be found in the introductory article of this supplement or at the StaR Child Health Web site (www.starchildhealth.org).",

year = "2012",

month = jun,

doi = "10.1542/peds.2012-0055H",

language = "English",

volume = "129",

pages = "S146--S152",

journal = "Pediatrics",

issn = "0031-4005",

publisher = "American Academy of Pediatrics",

number = "SUPPL. 3",

}

Sinha, IP, Altman, DG, Beresford, MW, Boers, M, Clarke, M, Craig, J, Della Casa-Alberighi, O, Fernandes, RM, Hartling, L, Johnston, BC, Lux, A, Plint, A, Tugwell, P, Turner, M, van der Lee, JH, Offringa, M, Williamson, PR & Smyth, RL 2012, 'Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children', Pediatrics, vol. 129, no. SUPPL. 3, pp. S146-S152. https://doi.org/10.1542/peds.2012-0055H

TY - JOUR

T1 - Standard 5

T2 - Selection, measurement, and reporting of outcomes in clinical trials in children

AU - Sinha, Ian P.

AU - Altman, Douglas G.

AU - Beresford, Michael W

AU - Boers, Maarten

AU - Clarke, Mike

AU - Craig, Jonathan

AU - Della Casa-Alberighi, Ornella

AU - Fernandes, Ricardo M.

AU - Hartling, Lisa

AU - Johnston, Bradley C.

AU - Lux, Andrew

AU - Plint, Amy

AU - Tugwell, Peter

AU - Turner, Mark

AU - van der Lee, Johanna H

AU - Offringa, Martin

AU - Williamson, Paula R

AU - Smyth, Rosalind L.

N1 - This is the fifth in a series of standard articles resulting from an ongoing process in which a group of invited experts called a Standard Development Group from StaR Child Health assembles and exchanges information about methods for pediatric trial design, conduct, and reporting. More detailed information about this topic can be found in the introductory article of this supplement or at the StaR Child Health Web site (www.starchildhealth.org).

PY - 2012/6

Y1 - 2012/6

N2 - People making choices in health care should use the findings of clinical trials (ideally, incorporated in systematic reviews) to inform their decisions. If these findings are to be useful and reliable, researchers must select appropriate outcomes, measure them in a scientifically robust manner, and report results thoroughly. There are difficulties, however, relating to the selection and measurement of outcomes in clinical trials, and special considerations are needed when these studies are conducted in children.This article provides guidance for researchers working on clinical trials in children. Although this article is focused on trials of effectiveness, which are similar to therapeutic confirmatory trials, certain sections may also relate to efficacy trials, pharmacokinetic trials, therapeutic exploratory trials, and trials conducted earlier in drug development.

AB - People making choices in health care should use the findings of clinical trials (ideally, incorporated in systematic reviews) to inform their decisions. If these findings are to be useful and reliable, researchers must select appropriate outcomes, measure them in a scientifically robust manner, and report results thoroughly. There are difficulties, however, relating to the selection and measurement of outcomes in clinical trials, and special considerations are needed when these studies are conducted in children.This article provides guidance for researchers working on clinical trials in children. Although this article is focused on trials of effectiveness, which are similar to therapeutic confirmatory trials, certain sections may also relate to efficacy trials, pharmacokinetic trials, therapeutic exploratory trials, and trials conducted earlier in drug development.

KW - health care

KW - decision making

KW - clinical trials

KW - children

KW - Pediatrics

KW - Outcome measures

KW - StaR child health

KW - Outcome sets

KW - Selective reporting

UR - http://www.scopus.com/inward/record.url?scp=84861855339&partnerID=8YFLogxK

U2 - 10.1542/peds.2012-0055H

DO - 10.1542/peds.2012-0055H

M3 - Article

C2 - 22661761

SN - 0031-4005

VL - 129

SP - S146-S152

JO - Pediatrics

JF - Pediatrics

IS - SUPPL. 3

ER -

Standard 5: Selection, measurement, and reporting of outcomes in clinical trials in children

Abstract

Bibliographical note

Keywords

Access to Document

Other files and links

Fingerprint

Cite this