Evidence map›Paper›PMID 24495582›Full record

ReviewTrials2014

Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs).

Rhiannon C Macefield, Marc Jacobs, Ida J Korfage, Joanna Nicklin, Robert N Whistance, Sara T Brookes, Mirjam A G Sprangers, Jane M Blazeby

Open access · goldAbstract readReview
In one paragraph

Review in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 95 papers, 25 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 25 pooled it
75.2field-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

95 citing papers in PubMed, 25 syntheses or guidelines pooled it, 184 citations in OpenAlex.

  1. Pooled it
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  8. Botulinum toxin type A versus anticholinergics for cervical dystonia.The Cochrane database of systematic reviews · 2021
    Pooled it
  9. Botulinum toxin type A therapy for hemifacial spasm.The Cochrane database of systematic reviews · 2020
    Pooled it
  10. Botulinum toxin type A therapy for blepharospasm.The Cochrane database of systematic reviews · 2020
    Pooled it
  11. Botulinum toxin type A therapy for cervical dystonia.The Cochrane database of systematic reviews · 2020
    Pooled it
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  13. Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2018
    Pooled it
  14. Botulinum toxin type A therapy for cervical dystonia.The Cochrane database of systematic reviews · 2017
    Pooled it
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  17. Guideline
  18. Botulinum toxin type A versus botulinum toxin type B for cervical dystonia.The Cochrane database of systematic reviews · 2016
    Pooled it
  19. Patient-reported outcome measures for cancer caregivers: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2016
    Pooled it
  20. Pooled it

35 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 5 institutions in 2 countries.

Rhiannon C MacefieldSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK. r.macefield@bristol.ac.uk.
Marc Jacobs
Ida J Korfage
Joanna Nicklin
Robert N Whistance
Sara T Brookes
Mirjam A G Sprangers
Jane M Blazeby
University of Bristol · GBUniversity of Amsterdam · NLBristol Royal Infirmary · GBErasmus University Rotterdam · NLUniversity Hospitals Bristol NHS Foundation Trust · GB

Funding

Department of Health PB-PG-0807-14131Department of Health RP-DG-1209-10031Department of Health RP-PG-0611-20008Medical Research Council G0800800
6 · The paper itself

Abstract

backgroundSynthesis of patient-reported outcome (PRO) data is hindered by the range of available PRO measures (PROMs) composed of multiple scales and single items with differing terminology and content. The use of core outcome sets, an agreed minimum set of outcomes to be measured and reported in all trials of a specific condition, may improve this issue but methods to select core PRO domains from the many available PROMs are lacking. This study examines existing PROMs and describes methods to identify health domains to inform the development of a core outcome set, illustrated with an example.

methodsSystematic literature searches identified validated PROMs from studies evaluating radical treatment for oesophageal cancer. PROM scale/single item names were recorded verbatim and the frequency of similar names/scales documented. PROM contents (scale components/single items) were examined for conceptual meaning by an expert clinician and methodologist and categorised into health domains. A patient advocate independently checked this categorisation.

resultsSearches identified 21 generic and disease-specific PROMs containing 116 scales and 32 single items with 94 different verbatim names. Identical names for scales were repeatedly used (for example, 'physical function' in six different measures) and others were similar (overlapping face validity) although component items were not always comparable. Based on methodological, clinical and patient expertise, 606 individual items were categorised into 32 health domains.

conclusionThis study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.

Indexed as

Health StatusHealth Status IndicatorsOutcome and Process Assessment, Health CarePatientsSelf ReportChecklistEsophageal NeoplasmsHumansMental HealthPredictive Value of TestsQuality of LifeRecovery of FunctionReproducibility of ResultsTerminology as TopicTreatment Outcome

Identifiers

PMID24495582
PMCPMC3916696
OpenAlexW2135896320

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.