Evidence map›Paper›PMID 30744706›Full record

GuidelineTrials2019

Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement.

Jamie J Kirkham, Sarah Gorst, Douglas G Altman, Jane M Blazeby, Mike Clarke, Sean Tunis, Paula R Williamson, COS-STAP Group

Open access · goldAbstract readConsensus StatementGuideline
In one paragraph

Guideline in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 154 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
154citing papers in PubMed, 6 pooled it
70.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

154 citing papers in PubMed, 6 syntheses or guidelines pooled it, 280 citations in OpenAlex.

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94 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Jamie J KirkhamMRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
Sarah GorstMRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK.
Douglas G AltmanCentre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Jane M BlazebyMRC ConDuCT II Hub for Trials Methodology Research, Population Health Sciences, University of Bristol, Bristol, UK.
Mike ClarkeNorthern Ireland Hub for Trials Methodology Research, Centre for Public Health, Queen's University Belfast, Belfast, UK.
Sean TunisCenter for Medical Technology Policy, Baltimore, USA.
Paula R WilliamsonMRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. prw@liv.ac.uk.ORCID http://orcid.org/0000-0001-9802-6636
COS-STAP Group
University of Liverpool · GBQueen's University Belfast · GBNuffield Orthopaedic Centre · GB

Funding

Cancer Research UK 16895Department of Health PDF-2015-08-015Medical Research Council G0901530Medical Research Council MR/K025635/1Medical Research Council MR/L004933/1Medical Research Council MR/L004933/2
6 · The paper itself

Abstract

backgroundSeveral hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol.

methodsThe COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network's methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants.

resultsThe COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes.

conclusionsJournal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out.

Indexed as

ChecklistConsensusDelphi TechniqueEndpoint DeterminationHumansResearch DesignStakeholder ParticipationCore outcome setGuidelineProtocol

Identifiers

PMID30744706
PMCPMC6371434
OpenAlexW2918963030

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.