Evidence map›Paper›PMID 30678703›Full record

Observational studyArthritis research & therapy2019

Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey.

J Blagojevic, S Bellando-Randone, G Abignano, J Avouac, L Cometi, L Czirják, C P Denton, O Distler, M Frerix, S Guiducci and 15 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01836263 (Prevention and Treatment of Digital Ulcers in Systemic Sclerosis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT01836263 unknown statusnot on this map

Prevention and Treatment of Digital Ulcers in Systemic Sclerosis

Typeobservational_patient_registrySponsormarco matucci cerinicRan2013 to 2017Enrolled420ConditionsSystemic Sclerosis, Ulcer
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 21 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
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

25 authors at 10 institutions in 6 countries.

J BlagojevicDepartment of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology and Scleroderma Unit AOUC, Villa Monna Tessa, viale Pieraccini 18, 50139, Florence, Italy. jelena308@hotmail.com.
S Bellando-RandoneDepartment of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology and Scleroderma Unit AOUC, Villa Monna Tessa, viale Pieraccini 18, 50139, Florence, Italy.
G AbignanoNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
J AvouacDepartment of Rheumatology, University of Paris Descartes, Paris, France.
L CometiDepartment of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology and Scleroderma Unit AOUC, Villa Monna Tessa, viale Pieraccini 18, 50139, Florence, Italy.
L CzirjákDepartment of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.
C P DentonDepartment of Rheumatology, University College London, Royal Free Hospital, London, UK.
O DistlerDepartment of Rheumatology, University Hospital Zurich, Zurich, Switzerland.
M FrerixDepartment of Rheumatology and Clinical Immunology, Kerckhoff-Klinik GmbH, Campus of the Justus-Liebig University Giessen, Bad Nauheim, Germany.
S GuiducciDepartment of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology and Scleroderma Unit AOUC, Villa Monna Tessa, viale Pieraccini 18, 50139, Florence, Italy.
D HuscherInstitute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate member of Freie Universitaet Berlin, Humboldt-Universitaet zu Berlin, and Berlin Institute of Health, Berlin, Germany.
V K JaegerDepartment of Rheumatology, University of Basel, Basel, Switzerland.
V LórándDepartment of Rheumatology and Immunology, University of Pécs, Pécs, Hungary.
B MaurerDepartment of Rheumatology, University Hospital Zurich, Zurich, Switzerland.
S NihtyanovaDepartment of Rheumatology, University College London, Royal Free Hospital, London, UK.
G RiemekastenClinic of Rheumatology and Clinical Immunology, University of Lübeck, Lübeck, Germany.
E SiegertDepartment of Rheumatology and Clinical Immunology, Charité - Universitaetsmedizin Berlin, Corporate member of Freie Universitaet Berlin, Humboldt-Universitaet zu Berlin, and Berlin Institute of Health, Berlin, Germany.
I H TarnerDepartment of Rheumatology and Clinical Immunology, Kerckhoff-Klinik GmbH, Campus of the Justus-Liebig University Giessen, Bad Nauheim, Germany.
S VettoriRheumatology Section, Department of Precision Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
U A WalkerDepartment of Rheumatology, University of Basel, Basel, Switzerland.
Y AllanoreDepartment of Rheumatology, University of Paris Descartes, Paris, France.
U Müller-LadnerDepartment of Rheumatology and Clinical Immunology, Kerckhoff-Klinik GmbH, Campus of the Justus-Liebig University Giessen, Bad Nauheim, Germany.
F Del GaldoNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
M Matucci-CerinicDepartment of Experimental and Clinical Medicine, University of Florence, and Department of Geriatric Medicine, Division of Rheumatology and Scleroderma Unit AOUC, Villa Monna Tessa, viale Pieraccini 18, 50139, Florence, Italy.
EUSTAR co-workers
Délégation Paris 5 · FRThe Royal Free Hospital · GBUniversity of Florence · ITJustus-Liebig-Universität Gießen · DEUniversity of Basel · CHUniversity of Leeds · GBCharité - Universitätsmedizin Berlin · DEHumboldt-Universität zu Berlin · DEUniversity Hospital of Zurich · CHUniversity of Campania "Luigi Vanvitelli" · IT

Funding

Department of Health CDF-2014-07-051European Community's Framework Programme 7 [FP7-HEALTH-2012.2.4.4-2 Observational trials in rare diseases] 305495
6 · The paper itself

Abstract

backgroundA consensus on digital ulcer (DU) definition in systemic sclerosis (SSc) has been recently reached (Suliman et al., J Scleroderma Relat Disord 2:115-20, 2017), while for their evaluation, classification and categorisation, it is still missing. The aims of this study were to identify a set of essential items for digital ulcer (DU) evaluation, to assess if the existing DU classification was useful and feasible in clinical practice and to investigate if the new categorisation was preferred to the simple distinction of DU in recurrent and not recurrent, in patients with systemic sclerosis (SSc).

methodsDeSScipher is the largest European multicentre study on SSc. It consists of five observational trials (OTs), and one of them, OT1, is focused on DU management. The DeSScipher OT1 items on DU that reached ≥ 60% of completion rate were administered to EUSTAR (European Scleroderma Trials and Research group) centres via online survey. Questions about feasibility and usefulness of the existing DU classification (DU due to digital pitting scars, to loss of tissue, derived from calcinosis and gangrene) and newly proposed categorisation (episodic, recurrent and chronic) were also asked.

resultsA total of 84/148 (56.8%) EUSTAR centres completed the questionnaire. DeSScipher items scored by ≥ 70% of the participants as essential and feasible for DU evaluation were the number of DU defined as a loss of tissue (level of agreement 92%), recurrent DU (84%) and number of new DU (74%). For 65% of the centres, the proposed classification of DU was considered useful and feasible in clinical practice. Moreover, 80% of the centres preferred the categorisation of DU in episodic, recurrent and chronic to simple distinction in recurrent/not recurrent DU.

conclusionsFor clinical practice, EUSTAR centres identified only three essential items for DU evaluation and considered the proposed classification and categorisation as useful and feasible. The set of items needs to be validated while further implementation of DU classification and categorisation is warranted.

trial registrationObservational trial on DU (OT1) is one of the five trials of the DeSScipher project (ClinicalTrials.gov; OT1 Identifier: NCT01836263 , posted on April 19, 2013).

Indexed as

FingersScleroderma, SystemicSkin UlcerAdultBosentanCalcium Channel BlockersDrug Therapy, CombinationEuropean UnionFemaleHumansIloprostMaleMiddle AgedProspective StudiesSildenafil CitrateSurveys and QuestionnairesBosentanCalcium Channel BlockersIloprostSildenafil CitrateCategorisationClassificationDigital ulcersEssential itemsSystemic sclerosis

Identifiers

PMID30678703
PMCPMC6346551
OpenAlexW2921835122

What OpenQuestion holds

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Registered trials

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.