Trial reportArthritis care & research2013
Evaluation of test characteristics for outcome measures used in Raynaud's phenomenon clinical trials.
Trial report in Arthritis care & research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.
- Behaviour change interventions for the management of Raynaud's phenomenon: a systematic literature review.BMJ open · 2018Pooled it
- The influence of Multiwave Locked System (MLS) laser therapy on clinical features, microcirculatory abnormalities and selected modulators of angiogenesis in patients with Raynaud's phenomenon.Clinical rheumatology · 2015Trial
- Identifying candidate core domains for clinical trials in systemic sclerosis-associated Raynaud's phenomenon and digital ulcers.Seminars in arthritis and rheumatism · 2026Article
- Using a smartphone app to monitor Raynaud's attacks and quantify skin colour changes-towards objective outcome measures for Raynaud's.Rheumatology (Oxford, England) · 2025Article
- Mobile phone thermal imaging as an ambulatory assessment tool in Raynaud's phenomenon.Rheumatology (Oxford, England) · 2023Article
- Hyperspectral imaging in systemic sclerosis-associated Raynaud phenomenon.Arthritis research & therapy · 2023Article
- Perfusion Scintigraphy for the Evaluation of Patients with Raynaud's Phenomenon.Nuclear medicine and molecular imaging · 2020Article
- An Interim Report of the Scleroderma Clinical Trials Consortium Working Groups.Journal of scleroderma and related disorders · 2019Article
- The patient experience of Raynaud's phenomenon in systemic sclerosis.Rheumatology (Oxford, England) · 2019Review
- Pharmacotherapy Options in the Management of Raynaud's Phenomenon.Current treatment options in rheumatology · 2018Article
- A Multicenter Study of the Validity and Reliability of Responses to Hand Cold Challenge as Measured by Laser Speckle Contrast Imaging and Thermography: Outcome Measures for Systemic Sclerosis-Related Raynaud's Phenomenon.Arthritis & rheumatology (Hoboken, N.J.) · 2018Article
- Points to consider-Raynaud's phenomenon in systemic sclerosis.Rheumatology (Oxford, England) · 2017Review
- Behaviour change interventions for the management of Raynaud's phenomenon: a systematic review protocol.BMJ open · 2017Article
- Clinical Trial Design Issues in Systemic Sclerosis: an Update.Current rheumatology reports · 2016Review
- A Randomized Controlled Trial of Acupressure for the Treatment of Raynaud's Phenomenon: The difficulty of conducting a trial in Raynaud's phenomenon.Journal of scleroderma and related disordersArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveRandomized controlled trials (RCTs) in Raynaud's phenomenon (RP) have shown conflicting efficacy data. Also, there is no consensus on the outcome measures that should be used. Our objectives were to assess the reliability of individual core set measures used in 3 RCTs, evaluate the placebo response for individual core set measures, and determine if a composite of individual core set measures will decrease the placebo response, which may improve our ability to see treatment effects in future trials.
methodsWe analyzed core set measures from 249 patients in the placebo-treated groups from 3 RCTs. Core set measures analyzed included the Raynaud's Condition Score (RCS); patient and physician assessment of RP; pain, numbness, and tingling during an RP attack; average number of attacks/day; and duration of attacks. Intraclass correlation coefficients (ICCs) were calculated during the run-in period to the RCTs.
resultsICCs of ≥0.70 were observed for the RCS, attack symptoms, and average attacks/day. A high placebo response rate was observed for all individual core measures except the duration of attacks. For the RCS, the placebo response ranged from 56% with ≥10% improvement to 19.5% with ≥60% improvement. In contrast, placebo response rates of 10-20% were observed when several core set measures were combined to develop a composite score.
conclusionOutcome measures used in RCTs of RP are associated with marked variability. A combination of outcome measures is associated with low placebo responses. Future studies are needed to assess if a composite score will be able to differentiate placebo from an effective agent.
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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.