Evidence map›Paper›PMID 28992167›Full record

SynthesisRheumatology (Oxford, England)2017

Muscle involvement in systemic sclerosis: points to consider in clinical trials.

Ulrich A Walker, Philip J Clements, Yannick Allanore, Oliver Distler, Chester V Oddis, Dinesh Khanna, Daniel E Furst

Open access · bronzeAbstract readSystematic Review
In one paragraph

Synthesis in Rheumatology (Oxford, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Sarcopenia in Autoimmune and Rheumatic Diseases: A Comprehensive Review.International journal of molecular sciences · 2020
    Review
  13. Article
  14. Review
  15. Article
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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

7 authors at 5 institutions in 3 countries.

Ulrich A WalkerDepartment of Rheumatology, Basel University, Basel, Switzerland.
Philip J ClementsDepartment of Rheumatology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.
Yannick AllanoreDepartment of Rheumatology and INSERM U1016, Descartes University, Cochin Hospital, Paris, France.
Oliver DistlerDepartment of Rheumatology, University Hospital Zurich, Zurich, Switzerland.
Chester V OddisDivision of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Dinesh KhannaDepartment of Medicine, University of Michigan, University of Michigan Scleroderma Program, Ann Arbor, MI, USA.
Daniel E FurstDepartment of Rheumatology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.
University of California, Los Angeles · USDélégation Paris 5 · FRScleroderma Foundation · USUniversity Hospital of Zurich · CHUniversity of Pittsburgh · US

Funding

Outcomes Research in Rheumatic DiseasesK24AR063120 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2012 to 2022
$1.6M
NIAMS NIH HHS K24 AR063120
6 · The paper itself

Abstract

SSc is clinically and pathogenetically heterogeneous. Consensus standards for trial design and outcome measures are needed. International experts experienced in SSc clinical trial design and a researcher experienced in systematic literature review screened the PubMed and Cochrane Central Register of Controlled Trials in order to develop points to consider when planning a clinical trial for muscle involvement in SSc. The experts conclude that SSc-associated muscle involvement is heterogeneous and lacks a universally accepted gold-standard for measuring therapeutic response. Although outcome studies are currently limited by the inability to clearly distinguish active, reversible muscle inflammation from irreversible muscle damage and extramuscular organ involvement, strong consideration should be given to enrolling patients with a myopathy that features several elements of likely reversibility such as muscle weakness, biopsy-proven active inflammation, an MRI indicating muscle inflammation and a baseline serum creatinine kinase above three times the upper limit of normal to prevent floor effect. Randomized controlled trials are preferred, with a duration of at least 24 weeks. Outcome measures should include a combination of elements that are likely to be reversible, such as muscle weakness, biopsy-proven active inflammation, creatinine kinase/aldolase and a quality of life questionnaire. The individual measurements might require a short pre-study for further validation. A biological sample repository is recommended.

Indexed as

Disease ManagementMuscular DiseasesClinical Trials as TopicHumansScleroderma, Systemicautoantibodiesidiopathic inflammatory myopathymuscle biopsymuscle enzymesmuscle imagingmuscle strengthmyositissclerodermatreatment outcometrial design

Identifiers

PMID28992167
PMCPMC5850276
OpenAlexW2764135729

What OpenQuestion holds

Textmetadata
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.