Evidence map›Paper›PMID 38625399›Full record

SynthesisJournal of neurology2024

Clinical trial evidence of quality-of-life effects of disease-modifying therapies for multiple sclerosis: a systematic analysis.

Julian Hirt, Kinga Dembowska, Tim Woelfle, Cathrine Axfors, Cristina Granziera, Jens Kuhle, Ludwig Kappos, Lars G Hemkens, Perrine Janiaud

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

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

  1. Pooled it
  2. Observational
  3. Article
  4. Observational
  5. Article
  6. Review
  7. Observational
  8. Review
  9. 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

9 authors.

Julian HirtResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0001-6589-3936
Kinga DembowskaResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0001-6903-2826
Tim WoelfleResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0001-6279-4158
Cathrine AxforsResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0002-2706-1730
Cristina GranzieraResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0002-4917-8761
Jens KuhleResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0002-6963-8892
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0003-4175-5509
Lars G HemkensResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland.ORCID http://orcid.org/0000-0002-3444-1432
Perrine JaniaudResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Spitalstrasse 2, CH-4031, Basel, Switzerland. perrine.janiaud@usb.ch.ORCID http://orcid.org/0000-0001-7684-8014

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncreasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis (PwMS).

methodsRandomized trials assessing approved DMTs in PwMS with results for at least one outcome referred to as "quality of life" were searched in PubMed and ClinicalTrials.gov.

resultsWe identified 38 trials published between 1999 and 2023 with a median of 531 participants (interquartile range (IQR) 202 to 941; total 23,225). The evaluated DMTs were mostly interferon-beta (n = 10; 26%), fingolimod (n = 7; 18%), natalizumab (n = 5; 13%), and glatiramer acetate (n = 4; 11%). The 38 trials used 18 different QoL instruments, with up to 11 QoL subscale measures per trial (median 2; IQR 1-3). QoL was never the single primary outcome. We identified quantitative QoL results in 24 trials (63%), and narrative statements in 15 trials (39%). In 16 trials (42%), at least one of the multiple QoL results was statistically significant. The effect sizes of the significant quantitative QoL results were large (median Cohen's d 1.02; IQR 0.3-1.7; median Hedges' g 1.01; IQR 0.3-1.69) and ranged between d 0.14 and 2.91.

conclusionsCertain DMTs have the potential to positively impact QoL of PwMS, and the assessment and reporting of QoL is suboptimal with a multitude of diverse instruments being used. There is an urgent need that design and reporting of clinical trials reflect the critical importance of QoL for PwMS.

Indexed as

Multiple SclerosisQuality of LifeHumansImmunologic FactorsOutcome Assessment, Health CareRandomized Controlled Trials as TopicImmunologic Factors(MeSH): Multiple sclerosisPatient-reported outcome measuresQuality of lifeRandomized controlled trialSystematic review

Identifiers

PMID38625399
PMCPMC11136790

What OpenQuestion holds

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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.