Evidence map›Paper›PMID 33528792›Full record

Observational studyAdvances in therapy2021

A Prospective, Observational, Cohort Study to Assess the Efficacy and Safety of Prolonged-Release Fampridine in Cognition, Fatigue, Depression, and Quality of Life in Multiple Sclerosis Patients: The FAMILY Study.

Dimos D Mitsikostas, Triantafyllos Doskas, Stylianos Gkatzonis, Nikolaos Fakas, Maria Maltezou, Dimitrios Papadopoulos, Rania Gourgioti, Panayiotis Mitsias

Registry-linked trialOpen access · hybridAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03164018 (Fampridine in MS Patients), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 17% 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.

NCT03164018 completednot on this map

Fampridine in MS Patients: A Cognition, Fatigue, Depression and Quality of Life Analysis

TypeobservationalSponsorGenesis Pharma CNS & SpecialtyRan2017 to 2018Enrolled111ConditionsMultiple SclerosisArmsFampridine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
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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 7 institutions in 1 country.

Dimos D Mitsikostas1St Neurology Department, School of Medicine, National and Kapodistrian University of Athens, Aeginition Hospital, Athens, Greece. dimosmitsikostas@me.com.
Triantafyllos DoskasDepartment of Neurology, Athens Naval Hospital, Athens, Greece.
Stylianos GkatzonisDepartment of Neurology, Evangelismos Athens General Hospital, Athens, Greece.
Nikolaos FakasNeurology Department, 401 General Military Hospital of Athens, Athens, Greece.
Maria MaltezouDepartment of Neurology, General Oncology Hospital of Kifissia "Agioi Anargiroi", Athens, Greece.
Dimitrios PapadopoulosNeurology Department, Athens Medical Centre, Paleo Phaliro Clinic, Athens, Greece.
Rania GourgiotiMedical CNS Department, Genesis Pharma SA, Athens, Greece.
Panayiotis MitsiasNeurology Department, University General Hospital of Heraklion, Heraklion Crete, Greece.
401 General Military Hospital of Athens · GRAthens Medical Center · GRAthens Naval & Veterans Hospital · GREvangelismos Hospital · GRHospital Agioi Anargyroi · GRNational and Kapodistrian University of Athens · GRUniversity Hospital of Heraklion · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe efficacy of prolonged-release fampridine (PR-FAM) may extend in multiple sclerosis (MS) beyond walking ability. The objective of this study was to evaluate the effect of PR-FAM treatment on cognition, fatigue, depression, and quality of life (QoL) in adult patients with MS in a real-world setting.

methodsFAMILY was a multi-center, prospective, observational, real-world cohort study of MS patients receiving PR-FAM in the outpatient setting. Patients were treated as per PR-FAM's local prescribing information for 6 months. Standardized protocols and questionnaires were used to evaluate changes in cognition (PASAT; Paced Auditory Serial Addition Test), fatigue (MFIS; Modified Fatigue Impact Scale), depression (BDI-II; Beck Depression Inventory-II) and QoL (MusiQoL; MS International Quality-of-Life questionnaire, MSIS-29; Multiple Sclerosis Impact Scale: PHYS and PSYCH subscales) at 3 and 6 months compared to baseline.

resultsIn total, 102 eligible patients from 8 sites in Greece were analysed, of whom 92 completed the study and 10 discontinued. At 6 months, PR-FAM treatment resulted in improvements from baseline in PASAT-3'' (p = 0.044), MFIS (p < 0.001), BDI-II (p < 0.001), MusiQoL (p < 0.001) and MSIS-29-PHYS (p = 0.012) and MSIS-PSYCH (p < 0.001). A positive effect was evident already at 3 months in PASAT-3'' (ns), MFIS (p = 0.020), BDI-II (p = 0.034), MusiQoL (p = 0.001), MSIS-29-PHYS (ns) and MSIS-29-PSYCH (p < 0.001).

conclusionsThis observational study provides new data to the current literature in support of PR-FAM's positive effects in cognition, fatigue, depression, and QoL in a large, heterogeneous group of Greek MS patients in the real-world setting.

trial registrationClinicalTrials.gov identifier, NCT03164018.

Indexed as

Multiple SclerosisQuality of LifeAdultCognitionCohort StudiesDepressionFatigueGreeceHumansProspective StudiesCognitionDepressionFatigueMultiple sclerosisNeurologyPR-FAMQoLWalking ability

Identifiers

PMID33528792
PMCPMC7932964
OpenAlexW3126315166

What OpenQuestion 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 OpenQuestion graph.