Evidence map›Paper›PMID 33294203›Full record

ArticleCanadian journal of kidney health and disease2020

The DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS) Trial: A Protocol for a Randomized, Crossover, Placebo-Controlled Blinded Trial.

David Collister, Kayla Pohl, Gwen Herrington, Shun Fu Lee, Christian Rabbat, Karthik Tennankore, Deborah Zimmermann, Navdeep Tangri, Ron Wald, Braden Manns and 5 more

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

Article in Canadian journal of kidney health and disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03806530 (DIalysis Symptom COntrol-Restless Legs Syndrome Trial), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT03806530 phase3completednot on this map

DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial

TypeinterventionalSponsorPopulation Health Research InstituteRan2019 to 2022Enrolled52ConditionsEnd Stage Renal Disease, Restless Legs SyndromeArmsGabapentin, Ropinirole, Placebo Gabapentin, Placebo Ropinirole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Restless Legs Syndrome in Chronic Kidney Disease- a Systematic Review.Tremor and other hyperkinetic movements (New York, N.Y.) · 2023
    Pooled it
  2. Article
  3. Sleep disorders in chronic kidney disease.Nature reviews. Nephrology · 2024
    Review
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

15 authors at 10 institutions in 1 country.

David CollisterPopulation Health Research Institute, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0002-2323-6521
Kayla PohlPopulation Health Research Institute, Hamilton, ON, Canada.
Gwen HerringtonCanadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD), Vancouver, BC, Canada.
Shun Fu LeePopulation Health Research Institute, Hamilton, ON, Canada.
Christian RabbatDepartment of Medicine, McMaster University, Hamilton, ON, Canada.
Karthik TennankoreDepartment of Medicine, Dalhousie University, Halifax, NS, Canada.
Deborah ZimmermannDepartment of Medicine, University of Ottawa, ON, Canada.
Navdeep TangriDepartment of Medicine, University of Manitoba, Winnipeg, Canada.
Ron WaldDepartment of Medicine, University of Toronto, ON, Canada.
Braden MannsDepartment of Medicine and Community Health Sciences, University of Calgary, AB, Canada.ORCID https://orcid.org/0000-0002-8823-6127
Rita S SuriDepartment of Medicine, McGill University, Montréal, QC, Canada.ORCID https://orcid.org/0000-0002-0519-3927
Annie-Claire Nadeau-FredetteFaculté de Médecine, Université de Montréal, QC, Canada.
Remi GoupilFaculté de Médecine, Université de Montréal, QC, Canada.
Samuel A SilverDepartment of Medicine, Queen's University, Kingston, ON, Canada.ORCID https://orcid.org/0000-0002-1843-6131
Michael WalshPopulation Health Research Institute, Hamilton, ON, Canada.
Population Health Research Institute · CAUniversité de Montréal · CADalhousie University · CAMcGill University · CAMcMaster University · CAQueen's University · CAUniversity of Calgary · CAUniversity of Manitoba · CAUniversity of Ottawa · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRestless legs syndrome (RLS) affects approximately 30% of patients with end-stage kidney disease and is associated with impaired sleep and health-related quality of life. Medications used to treat RLS in patients receiving dialysis may have an increased risk of adverse events with dose titration, and residual RLS symptoms are common despite the use of effective treatments. Randomized controlled trials of monotherapy and combination pharmacologic therapy for RLS in hemodialysis are needed.

objectiveTo perform a randomized, crossover, placebo-controlled blinded trial of pharmacologic therapy for RLS in hemodialysis. DESIGN/

settingThe DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS) trial is a randomized, crossover, placebo-controlled blinded trial of fixed low-dose pharmacologic therapy in patients receiving hemodialysis in 10 centers across Canada. It uses patient partners in its design, conduct, and reporting.

participantsAdults receiving thrice-weekly hemodialysis for at least 3 months with RLS of at least mild symptoms defined International Restless Legs Syndrome Study Group Rating Scale (IRLS) of 10 or more will enter a double placebo run-in period to exclude nonadherent participants and those unable to tolerate double placebo. Seventy-two participants who completed the run-in period will be randomized to 1 of 8 treatment sequences based on modeling with 4 treatment periods.

methodsEach treatment period lasts 4 weeks and consists of ropinirole 0.5 mg daily and gabapentin 100 mg daily, both together or neither with a double dummy placebo control for each treatment. The primary outcome is the difference in change scores of the IRLS between study treatments. Secondary outcomes are the differences in change scores of the Restless Legs Syndrome-6 Scale, patient global impression, 5-level EQ-5D version, and safety outcomes.

resultsThis randomized, crossover, placebo-controlled blinded trial will evaluate the efficacy and safety of fixed low-dose combination of ropinirole and gabapentin in patients receiving hemodialysis with RLS. LIMITATIONS: Patients with chronic kidney disease not on dialysis, kidney transplant recipients and those receiving peritoneal dialysis or home hemodialysis are not included. The intervention's long term safety and efficacy including the risk of augmentation is not captured.

conclusionThis randomized crossover placebo controlled blinded trial will evaluate the efficacy and safety of fixed low-dose combination ropinirole and gabapentin in patients receiving hemodialysis with RLS.

trial registrationClinicalTrials.gov (NCT03806530).

Indexed as

controlled trialcrossoverhemodialysisrandomizedrestless legs syndrome

Identifiers

PMID33294203
PMCPMC7705292
OpenAlexW3108884852

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.