Evidence map›Paper›PMID 26393519›Full record

SynthesisPloS one2015

Evaluation of Study and Patient Characteristics of Clinical Studies in Primary Progressive Multiple Sclerosis: A Systematic Review.

T Ziemssen, S Rauer, C Stadelmann, T Henze, J Koehler, I-K Penner, M Lang, D Poehlau, M Baier-Ebert, H Schieb and 1 more

Abstract readSystematic Review
In one paragraph

Synthesis in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Deciphering Multiple Sclerosis Progression.Frontiers in neurology · 2021
    Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. 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

11 authors.

T ZiemssenUniversity Clinic Carl Gustav Carus Dresden, Center of Clinical Neuroscience, Dresden, Germany.
S RauerAlbert-Ludwigs-Universitaet Freiburg, Neurologische Klinik und Poliklinik, Freiburg, Germany.
C StadelmannGeorg August University, University Medical Center Göttingen, Department of Neuropathology, Göttingen, Germany.
T HenzePASSAUER WOLF Reha-Zentrum Nittenau, Rehabilitationsklinik für Neurologie-Geriatrie-Urologie, Nittenau, Germany.
J KoehlerMarianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen, Berg, Germany.
I-K PennerUniversity of Basel, Department of Cognitive Psychology and Methodology, Basel, Switzerland.
M LangNeuropoint Patient Academy, Neurological Practice Center, Ulm, Germany.
D PoehlauDRK Kamillus-Klinik, Asbach, Germany.
M Baier-EbertNovartis Pharma GmbH, Nuremberg, Germany.
H SchiebNovartis Pharma GmbH, Nuremberg, Germany.
S MeuthUniversity of Muenster, Department of Neurology, Muenster, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSo far, clinical studies in primary progressive MS (PPMS) have failed to meet their primary efficacy endpoints. To some extent this might be attributable to the choice of assessments or to the selection of the study population.

objectiveThe aim of this study was to identify outcome influencing factors by analyzing the design and methods of previous randomized studies in PPMS patients without restriction to intervention or comparator.

methodsA systematic literature search was conducted in MEDLINE, EMBASE, BIOSIS and the COCHRANE Central Register of Controlled Trials (inception to February 2015). Keywords included PPMS, primary progressive multiple sclerosis and chronic progressive multiple sclerosis. Randomized, controlled trials of at least one year's duration were selected if they included only patients with PPMS or if they reported sufficient PPMS subgroup data. No restrictions with respect to intervention or comparator were applied. Study quality was assessed by a biometrics expert. Relevant baseline characteristics and outcomes were extracted and compared.

resultsOf 52 PPMS studies identified, four were selected. Inclusion criteria were notably different among studies with respect to both the definition of PPMS and the requirements for the presence of disability progression at enrolment. Differences between the study populations included the baseline lesion load, pretreatment status and disease duration. The rate of disease progression may also be an important factor, as all but one of the studies included a large proportion of patients with a low progression rate. In addition, the endpoints specified could not detect progression adequately.

conclusionOptimal PPMS study methods involve appropriate patient selection, especially regarding the PPMS phenotype and progression rate. Functional composite endpoints might be more sensitive than single endpoints in capturing progression.

Indexed as

Randomized Controlled Trials as TopicResearch DesignDisease ProgressionFemaleHumansMaleMultiple Sclerosis, Chronic ProgressiveOutcome Assessment, Health CarePatient SelectionReproducibility of Results

Identifiers

PMID26393519
PMCPMC4578855

What OpenQuestion holds

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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.