Evidence map›Paper›PMID 26806474›Full record

ArticleArthritis care & research2016

The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis.

Dinesh Khanna, Veronica J Berrocal, Edward H Giannini, James R Seibold, Peter A Merkel, Maureen D Mayes, Murray Baron, Philip J Clements, Virginia Steen, Shervin Assassi and 14 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Arthritis care & research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Patient-reported outcome instruments in clinical trials of systemic sclerosis.Journal of scleroderma and related disorders · 2020
    Review
  8. Observational
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

24 authors.

Dinesh KhannaUniversity of Michigan, Ann Arbor.
Veronica J BerrocalUniversity of Michigan, Ann Arbor.
Edward H GianniniCincinnati Children's Hospital, Cincinnati, Ohio.
James R SeiboldScleroderma Research Consultants, Litchfield, Connecticut.
Peter A MerkelUniversity of Pennsylvania, Philadelphia.
Maureen D MayesUniversity of Texas Health Science Center at Houston.
Murray BaronJewish General Hospital and McGill University, Montreal, Quebec, Canada.
Philip J ClementsUniversity of California, Los Angeles.
Virginia SteenGeorgetown University, Washington, DC.
Shervin AssassiUniversity of Texas Health Science Center at Houston.
Elena SchiopuUniversity of Michigan, Ann Arbor.
Kristine PhillipsUniversity of Michigan, Ann Arbor.
Robert W SimmsBoston University, Boston, Massachusetts.
Yannick AllanoreParis Descartes University and Cochin Hospital, AP-HP, Paris, France.
Christopher P DentonRoyal Free and University College London Medical School, London, UK.
Oliver DistlerToronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.
Sindhu R JohnsonToronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.
Marco Matucci-CerinicAzienda Ospedaliero-Universitaria Careggi (AOUC) and University of Florence, Florence, Italy.
Janet E PopeSchulich School of Medicine, Western University, London Campus, and St. Joseph's Health Care, London, Ontario, Canada.
Susanna M ProudmanRoyal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia.
Jeffrey SiegelGenentech/Roche, San Francisco, California.
Weng Kee WongUniversity of California, Los Angeles.
Athol U WellsRoyal Brompton Hospital, London, UK.
Daniel E FurstUniversity of California, Los Angeles.

Funding

Outcomes Research in Rheumatic DiseasesK24AR063120 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2012 to 2022
$1.6M
Provisional Combined Response Index For Patients With Diffuse Systemic SclerosisU01AR055057 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI FURST, DANIEL ERIC · 2007 to 2009
$1.1M
Pain Mechanisms and Outcomes in OsteoarthritisK23AR060241 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI PHILLIPS, KRISTINE · 2011 to 2015
$670k
CIHRNIAMS NIH HHS K23 AR060241NIAMS NIH HHS K24 AR063120NIAMS NIH HHS K24-AR-063120NIAMS NIH HHS U01 AR055057NIAMS NIH HHS U01-AR-055057Versus Arthritis 20719
6 · The paper itself

Abstract

objectiveEarly diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs).

methodsWe developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT.

resultsSixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT (P = 0.02).

conclusionWe have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc.

Indexed as

Randomized Controlled Trials as TopicScleroderma, DiffuseSeverity of Illness IndexAdultFemaleHumansMaleMiddle AgedPsychometricsRheumatology

Identifiers

PMID26806474
PMCPMC4818571

What OpenQuestion holds

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Registered trials

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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.