Evidence map›Paper›PMID 24827533›Full record

GuidelineAnnals of the rheumatic diseases2015

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.

Maya H Buch, Lucia Silva-Fernandez, Loreto Carmona, Daniel Aletaha, Robin Christensen, Bernard Combe, Paul Emery, Gianfranco Ferraccioli, Francis Guillemin, Tore K Kvien and 12 more

Abstract readGuideline
In one paragraph

Guideline in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

32 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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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

22 authors.

Maya H BuchLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Lucia Silva-FernandezRheumatology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain.
Loreto CarmonaInstitute for Musculoskeletal Health, Madrid, Spain.
Daniel AletahaDepartment of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Vienna, Austria.
Robin ChristensenDepartment of Rheumatology, Musculoskeletal Statistics Unit, The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.
Bernard CombeDepartment of Rheumatology, Lapeyronie Hospital, Montpellier I University of Montpellier, France.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Gianfranco FerraccioliDivision of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy.
Francis GuilleminUniversité de Lorraine, Université Paris Descartes, Nancy, France.
Tore K KvienDepartment of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Robert LandeweAcademic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Karel PavelkaInstitute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic.
Kenneth SaagDivision of Clinical Immunology and Rheumatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.
Josef S SmolenDepartment of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Vienna, Austria 2nd Department of Medicine, Center for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria.
Deborah SymmonsArthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Trust, Manchester, UK.
Désirée van der HeijdeLeiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands.
Joep WellingEULAR Patient Research Partner, Ede, The Netherlands.
George WellsDepartment of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada.
Rene WesthovensDepartment of Development and Regeneration, KU Leuven, Skeletal Biology and Engineering Research Center, Leuven, Belgium Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium.
Angela ZinkGerman Rheumatism Research Centre, Berlin, Germany.
Maarten BoersDepartment of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
European League Against Rheumatism (EULAR)

Funding

Department of Health MANMKBRU-2012-1Versus Arthritis 18475
6 · The paper itself

Abstract

objectivesOur initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.

methodsWe formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.

resultsSeven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.

conclusionsThis EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.

Indexed as

Randomized Controlled Trials as TopicRheumatologyAdvisory CommitteesDelphi TechniqueHumansResearch DesignResearch ReportDMARDs (biologic)EpidemiologyRheumatoid Arthritis

Identifiers

PMID24827533
PMCPMC4431343

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.