Evidence map›Paper›PMID 26387883›Full record

Trial reportNeuromodulation : journal of the International Neuromodulation Society2016

The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.

Sam Eldabe, Simon Thomson, Rui Duarte, Morag Brookes, Mark deBelder, Jon Raphael, Ed Davies, Rod Taylor

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuromodulation : journal of the International Neuromodulation Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
4.5field-weighted citation impact, top 5% 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.

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

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Comparison of clinical outcomes associated with spinal cord stimulation (SCS) or conventional medical management (CMM) for chronic pain: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Improvement in quality of life and angina pectoris: 1-year follow-up of patients with refractory angina pectoris and spinal cord stimulation.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2020
    Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. 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

8 authors at 6 institutions in 1 country.

Sam EldabeDepartment of Pain and Anesthesia, The James Cook University Hospital, Middlesbrough, UK.
Simon ThomsonBasildon and Thurrock University Hospitals, Basildon, Nethermayne, UK.
Rui DuarteSchool of Health and Population Sciences, University of Birmingham, Birmingham, UK.
Morag BrookesDepartment of Pain and Anesthesia, The James Cook University Hospital, Middlesbrough, UK.
Mark deBelderDepartment of Cardiology, The James Cook University Hospital, Middlesbrough, UK.
Jon RaphaelDepartment of Pain Medicine, Dudley Group of Hospitals NHS Foundation Trust, Russells Hall Hospital, Dudley, West Midlands, UK.
Ed DaviesCardiothoracic Department, Plymouth Hospitals NHS Trust, Plymouth, UK.
Rod TaylorUniversity of Exeter Medical School, University of Exeter, Exeter, UK.
James Cook University Hospital · GBBasildon and Thurrock University Hospitals NHS Foundation Trust · GBPlymouth Hospital · GBRussells Hall Hospital · GBUniversity of Birmingham · GBUniversity of Exeter · GB

Funding

Department of Health PB-PG-1208-18031
6 · The paper itself

Abstract

backgroundPatients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting.

methodsRA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization.

resultsWe failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group.

conclusionsWhile patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial.

Indexed as

Cost-Benefit AnalysisTreatment OutcomeAgedAngina PectorisFeasibility StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementPilot ProjectsQuality of LifeRetrospective StudiesSpinal Cord StimulationRandomized controlled trialrefractory anginaspinal cord stimulation

Identifiers

PMID26387883
PMCPMC5054842
OpenAlexW2108609348

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.