Evidence map›Paper›PMID 40328675›Full record

ArticleLupus science & medicine2025

Domains for inclusion in a novel Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE): results of a modified Delphi study.

Kathryn Connelly, Rachel Koelmeyer, Darshini Ayton, John May, Kate Gregory, Laura E Eades, Raychel Barallon, Rangi Kandane-Rathnayake, Vera Golder, Afia Anzum and 44 more

Abstract read
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In one paragraph

Article in Lupus science & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Observational
  4. 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

54 authors.

Kathryn Connelly *Centre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Rachel Koelmeyer *Centre for Inflammatory Diseases, Monash University, Clayton, Victoria, Australia.
Darshini AytonSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
John MayCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Kate GregoryCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Laura E EadesCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Raychel BarallonCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Rangi Kandane-RathnayakeDepartment of Medicine, Monash University, Clayton, Victoria, Australia.ORCID 0000-0001-5397-1482
Vera GolderCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Afia AnzumCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Maisarah MydinCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Munni AktherCentre for Inflammatory Diseases, Monash University, Melbourne, Victoria, Australia.
Alan FriedmanAbbVie, North Chicago, Illinois, USA.
Anca D AskanaseColumbia University Irving Medical Center, New York City, New York, USA.ORCID 0000-0003-4597-5023
Cynthia AranowAutoimmune and Musculoskeletal Disease, The Feinstein Institute for Medical Research, Manhasset, New York, USA.ORCID 0000-0001-9299-0053
Edward VitalLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Guillermo Pons-EstelCentro Regional de Enfermedades Autoinmunes y Reumáticas (GO-CREAR), Rosario, Santa Fe, Argentina.ORCID 0000-0002-0647-929X
Hermine BrunnerCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID 0000-0001-9478-2987
Kenneth KalunianDepartment of Medicine, UCSD, La Jolla, California, USA.
Khadija DantataLupus Foundation of America, Washington, District of Columbia, USA.
Laurent ArnaudDepartment of Rheumatology, Hôpitaux universitaires de Strasbourg, Strasbourg, France.ORCID 0000-0002-8077-8394
Laurie BurkeLORA Group, Normal, Illinois, USA.
Lee S SimonSDA LLC, Annapolis, Maryland, USA.
Qing ZurawJanssen Research & Development LLC, Raritan, New Jersey, USA.
Sandra GarcesAmgen, Thousand Oaks, California, USA.ORCID 0000-0002-6601-5155
Victoria P WerthDepartment of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Ying B SunMerck Healthcare Germany GmbH, Weiterstadt, Germany.
Yoshiya TanakaUniversity of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID 0000-0002-0807-7139
Youmna LahoudBiogen, Cambridge, Massachusetts, USA.
Alain CornetLupus Europe, Brussels, Belgium.
Alessandro SorrentinoBioPharmaceuticals Medical, AstraZeneca UK Limited, Cambridge, UK.
Anisur RahmanMedicine (Rheumatology), University College London, London, UK.ORCID 0000-0003-2346-4484
Anna StevensBristol Myers Squibb, Budapest, New Jersey, USA.
Catherine BarbeyBiogen Switzerland AG, Baar, Switzerland.
Ida Dzifa DeyInternal Medicine, University of Ghana, Legon, Ghana.
Elaine KarisAmgen, Thousand Oaks, California, USA.
Eloisa BonfáRheumatology, Universidade de Sao Paulo Faculdade de Medicina, Sao Paulo, Brazil.
Erika NossJanssen Research & Development Spring House, Spring House, Pennsylvania, USA.
Eve M D SmithUniversity of Liverpool, Liverpool, UK.
George StojanUCB Pharma SA Belgium, Brussels, Belgium.
Jeanette AndersenLupus Europe, Brussels, Belgium.
Joseph F MerolaBrigham and Women's Hospital, Boston, Massachusetts, USA.
Jorge A Ross TerresGenentech, South San Francisco, California, USA.
Joy BuieResearch, Lupus Foundation of America, Washington, District of Columbia, USA.ORCID 0000-0003-4026-4812
Justine MallerGenentech, South San Francisco, California, USA.
Marta MoscaDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Maja HojnikEli Lilly and Company, Indianapolis, Indiana, USA.
Maria Dall'EraUniversity of California San Francisco, San Francisco, California, USA.
Richard A FurieRheumatology, Northwell Health, Great Neck, New York, USA.ORCID 0000-0001-6712-1585
Ronald F van VollenhovenDepartment of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam, Netherlands.ORCID 0000-0001-6438-8663
Subhashis BanerjeeBristol Myers Squibb, Budapest, New Jersey, USA.
Eric MorandSub-Faculty of Clinical and Molecular Medicine, Monash University, Clayton, Victoria, Australia eric.morand@monash.edu.ORCID 0000-0002-9507-3338
TRM-SLE Taskforce Members
Delphi Participants

Funding

Pediatric musculOskeletal & RheumaTology Innovation COre center (PORTICO)P30AR076316 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI BRUNNER, HERMINE I · 2019 to 2023
$3.4M
NIAMS NIH HHS P30 AR076316
6 · The paper itself

Abstract

objectivesTo achieve consensus on domains of active disease for inclusion in a novel outcome measure for SLE randomised controlled trials (RCTs), the Treatment Response Measure for SLE (TRM-SLE).

methodsDomains nominated by TRM-SLE Taskforce members were rated in a two-stage modified Delphi study. Each stage comprised two online survey rounds separated by a structured discussion meeting. In Stage 1, expert lupus clinicians and patient representatives rated domain 'importance' (impact on symptoms, function or survival). In Stage 2, clinicians rated 'important' domains on three characteristics relevant to RCT utility: 'appropriateness' for evaluating change in disease activity, 'representation' in patients with active SLE and 'measurability' in an RCT context. Consensus for domain inclusion was prespecified as all four characteristics achieving a rating ≥7 on a 1-9 scale by ≥70% of participants.

resultsDomain nominations from 36/59 (61%) TRM-SLE Taskforce members yielded 34 potential domains which were rated in the modified Delphi study. At least one Delphi round was completed by 87 clinicians and 13 patient representatives. In Stage 1, 14 domains met consensus on 'importance' in both clinician and patient groups, and 11 domains met consensus among patients only. After Stage 2, eight of these domains also reached consensus on 'appropriateness', 'representation' and 'measurability': alopecia, arthritis, haemolytic anaemia, nephritis, mucosal ulcers, rash, serositis and thrombocytopenia.

conclusionsConsidering patient and clinician perspectives, we reached consensus to include eight disease activity domains for future development into the novel TRM-SLE clinical trial outcome measure, aiming to improve trial interpretability and success.

Indexed as

Lupus Erythematosus, SystemicOutcome Assessment, Health CareAdultConsensusDelphi TechniqueFemaleHumansMaleRandomized Controlled Trials as TopicSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeClinical TrialPatient Reported Outcome MeasuresSeverity of Illness IndexSystemic Lupus Erythematosus

Identifiers

PMID40328675
PMCPMC12067843

What OpenQuestion holds

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LicenceCC BY-NC
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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.