Evidence map›Paper›PMID 28203356›Full record

ArticleClinical investigation2014

Outcome measures in amyotrophic lateral sclerosis clinical trials.

Sabrina Paganoni, Merit Cudkowicz, James D Berry

Registry-linked trialAbstract read
In one paragraph

Article in Clinical investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03326622 (The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 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.

NCT03326622 nacompletednot on this map

The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS

TypeinterventionalSponsorUniversity of LisbonRan2013 to 2015Enrolled48ConditionsAmyotrophic Lateral SclerosisArmsstandard care, moderate exercise
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

3 authors.

Sabrina PaganoniHarvard Medical School, Department of Neurology, Neurological Clinical Research Institute (NCRI), Massachusetts Genera Hospital, MA, USA; Harvard Medical School, Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital, Boston, MA, USA.
Merit CudkowiczHarvard Medical School, Department of Neurology, Neurological Clinical Research Institute (NCRI), Massachusetts Genera Hospital, MA, USA.
James D BerryHarvard Medical School, Department of Neurology, Neurological Clinical Research Institute (NCRI), Massachusetts Genera Hospital, MA, USA.

Funding

Rehabilitation Medicine Scientist Training (RMST) ProgramK12HD001097 · NICHD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BONINGER, MICHAEL L. · 1995 to 2016
$14.1M
NICHD NIH HHS K12 HD001097
6 · The paper itself

Abstract

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3-5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Until recently, ALS clinical trials have relied on a limited cadre of 'traditional' outcome measures, including survival and measures of function. These measures have proven useful, although imperfect, in Phase III ALS trials. However, their utility in early-phase ALS trials is limited. For these early trials, outcome measures focused on target engagement or biological pathway analysis might improve trial outcomes and better support the drug development process.

Indexed as

biomarkerend pointfunctionsurrogatesurvival

Identifiers

PMID28203356
PMCPMC5305182

What OpenQuestion holds

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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.