Evidence map›Paper›PMID 38350062›Full record

SynthesisNeurology2024

Investigating the Prevalence of Comorbidity in Multiple Sclerosis Clinical Trial Populations.

Amber Salter, Samantha Lancia, Kaarina Kowalec, Kathryn C Fitzgerald, Ruth Ann Marrie

Open access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
10.2field-weighted citation impact, top 1% 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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Observational
  6. Review
  7. Review
  8. Motor fatigue and fatigability in early multiple sclerosis patients: an analysis of clinical, radiological and psychological underpinnings.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
    Article
  9. Article
  10. Comorbidity and modifiable risk factors in multiple sclerosis.Therapeutic advances in neurological disorders · 2026
    Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Depression and anxiety in multiple sclerosis. Review of a fatal combination.Journal of neural transmission (Vienna, Austria : 1996) · 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

5 authors at 1 institution in 3 countries.

Amber SalterFrom the Department of Neurology (A.S., S.L.), Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX; College of Pharmacy (K.K.), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.ORCID 0000-0002-1088-110X
Samantha LanciaFrom the Department of Neurology (A.S., S.L.), Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX; College of Pharmacy (K.K.), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.
Kaarina KowalecFrom the Department of Neurology (A.S., S.L.), Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX; College of Pharmacy (K.K.), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.ORCID 0000-0003-3928-9879
Kathryn C FitzgeraldFrom the Department of Neurology (A.S., S.L.), Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX; College of Pharmacy (K.K.), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.ORCID 0000-0003-3137-0322
Ruth Ann MarrieFrom the Department of Neurology (A.S., S.L.), Section on Statistical Planning and Analysis, UT Southwestern Medical Center, Dallas, TX; College of Pharmacy (K.K.), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institutet, Sweden; Department of Neurology (K.C.F.), Johns Hopkins School of Medicine, Baltimore, MD; and Departments of Internal Medicine and Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.ORCID 0000-0002-1855-5595
Johns Hopkins University · US

Funding

Extension of Combination Therapy for Multiple Sclerosis (eCombiRx)U01NS045719 · NINDS · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI LUBLIN, FRED D · 2003 to 2012
$44.7M
NINDS NIH HHS U01 NS045719
6 · The paper itself

Abstract

BACKGROUND AND

objectivesComorbidity is common in multiple sclerosis (MS) with the most prevalent conditions being depression, anxiety, hypertension, and hyperlipidemia. Limited information regarding the representation of comorbidity status is available from phase III clinical trials in MS leading to concern about the potential underrepresentation of individuals with comorbidity in clinical trials. The objective was to estimate the prevalence of comorbidities in MS clinical trial populations.

methodsIndividual-level data from multiple sponsors were requested for a 2-stage meta-analysis of phase III clinical trials of MS disease-modifying therapies. To ensure consistency of our approach across trials, we followed the Maelstrom retrospective harmonization guidelines. Chronic comorbidities at clinical trial enrollment recommended by the International Advisory Committee on Clinical Trials in MS were considered (depression, anxiety, hypertension, hyperlipidemia, migraine, diabetes, chronic lung disease). Additional comorbidities were also classified. Classification was based on medical history data. Individual comorbidities were summed and categorized as 0, 1, 2, or ≥3. We report the pooled prevalence (95% confidence interval [95% CI]) of comorbidity. The pooled prevalence and prevalence ratios across age, sex, race, disability level, and treatment were also reported. Heterogeneity was assessed using the I

resultsSeventeen trials involving 17,926 participants were included. Fourteen trials enrolled participants with relapsing MS (RMS) while 3 enrolled participants with progressive MS (PMS). The distributions of sex, age, and disability level were generally consistent within RMS and PMS trials. When pooled, almost half of trial participants (46.5%) had ≥1 comorbidity (1: 25.0%, 95% CI 23.0-27.0, I DISCUSSION: Individuals with comorbidities are included in clinical trials, although they may still be underrepresented compared with the general MS population. Given the comorbidity prevalence in the trial populations and studies suggesting an association of comorbidities with disease activity, comorbidity may influence outcomes in clinical trials.

Indexed as

HyperlipidemiasHypertensionMultiple SclerosisComorbidityFemaleHumansMalePrevalenceRetrospective Studies

Identifiers

PMID38350062
PMCPMC11067694
OpenAlexW4391797146

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.