Evidence map›Paper›PMID 19364728›Full record

Trial reportAnnals of the rheumatic diseases2010

The minimally important difference and patient acceptable symptom state for the Raynaud's condition score in patients with Raynaud's phenomenon in a large randomised controlled clinical trial.

Puja P Khanna, Paul Maranian, Jeff Gregory, Dinesh Khanna

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

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

  1. Calcium channel blockers for primary and secondary Raynaud's phenomenon.The Cochrane database of systematic reviews · 2017
    Pooled it
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  17. Patient-reported outcome instruments in clinical trials of systemic sclerosis.Journal of scleroderma and related disorders · 2020
    Review
  18. Review
  19. Pharmacotherapy Options in the Management of Raynaud's Phenomenon.Current treatment options in rheumatology · 2018
    Article
  20. A comparison of the scaling properties of the English, Spanish, French, and Chinese EQ-5D descriptive systems.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2013
    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

4 authors.

Puja P KhannaDivision of Rheumatology, Department of Medicine, David Geffen School of Medicine, Los Angeles, CA 90095, USA.
Paul Maranian
Jeff Gregory
Dinesh Khanna

Funding

Academic Training in RheumatologyT32AR053463 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SINGH, RAM RAJ · 2007 to 2011
$1.1M
Health Values and Minimally Important Differences in Systemic SclerosisK23AR053858 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2007 to 2011
$617k
NIAMS NIH HHS K23 AR053858NIAMS NIH HHS T32 AR053463
6 · The paper itself

Abstract

backgroundThe Raynaud's condition score (RCS) is a validated outcome measure for Raynaud's phenomenon (RP).

objectiveTo assess the minimally important difference (MID) and patient acceptable symptom state (PASS) for RCS in patients with RP. SUBJECTS: and methods Patients with active RP (n=162) (mean RCS >25 (0-100 visual analogue scale) participated in a placebo-controlled, crossover randomised clinical trial (RCT). Data from the two treatment groups were combined for this analysis. Retrospective and prospective anchors were administered during the RCT. MID groups were defined as the group who reported being somewhat better (anchor #1) and a one-step change from "unbearable" to "very severe", etc (anchor #2). Patients were considered to have achieved PASS if they rated their Raynaud's condition as "very mild" or "mild" at the last study visit.

resultsThe mean age of participants was 48.9 years and the mean baseline RCS was 46.4 points. The RCS change score for the MID improvement group ranged from -13.9 to -14.3 points and PASS estimate was 34.0 points.

conclusionThe MID and PASS estimates for RCS are 14-15 points for improvement and 34 points, respectively, on a 0-100 scale in a large RCT of patients with active RP. This information can aid in interpreting RCS in future RP trials.

Indexed as

AdolescentAdultAgedDisability EvaluationEpidemiologic MethodsFemaleHumansMaleMiddle AgedPatient Acceptance of Health CareRaynaud DiseaseVasodilator AgentsYoung AdultVasodilator Agents

Identifiers

PMID19364728
PMCPMC2837770

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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.