Evidence map›Paper›PMID 32910255›Full record

SynthesisJournal of neurology2021

A systematic review of neuropsychiatric and cognitive assessments used in clinical trials for amyotrophic lateral sclerosis.

Emily Beswick, Emily Park, Charis Wong, Arpan R Mehta, Rachel Dakin, Siddharthan Chandran, Judith Newton, Alan Carson, Sharon Abrahams, Suvankar Pal

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in Journal of neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 9% 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, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Clinimetrics of the cognitive section of the Italian ALS Cognitive Behavioral Screen (ALS-CBS™).Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Article
  15. Feasibility and diagnostics of the Frontal Assessment Battery (FAB) in amyotrophic lateral sclerosis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Article
  16. Review
  17. Cognitive reserve protects ALS-typical cognitive domains: A longitudinal study.Annals of clinical and translational neurology · 2022
    Article
  18. Article
  19. Article
  20. 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

10 authors at 4 institutions in 2 countries.

Emily BeswickCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.ORCID http://orcid.org/0000-0001-9843-0778
Emily ParkThe School of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, Scotland.
Charis WongCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.
Arpan R MehtaCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.ORCID http://orcid.org/0000-0002-5715-5025
Rachel DakinCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.
Siddharthan ChandranCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.
Judith NewtonCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.
Alan CarsonCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland.
Sharon AbrahamsEuan MacDonald Centre for MND Research, The University of Edinburgh, Edinburgh, Scotland.
Suvankar PalCentre for Clinical Brain Sciences, The University of Edinburgh, Edinburgh, Scotland. Suvankar.Pal@ed.ac.uk.
University of Edinburgh · GBUK Dementia Research Institute · GBLanguage Science (South Korea) · KRMRC Centre for Regenerative Medicine · GB

Funding

Medical Research Council MR/L023784/2Medical Research Council MR/R001162/1Motor Neurone Disease Association MEHTA/JUL17/948-795
6 · The paper itself

Abstract

backgroundUp to 50% of people with amyotrophic lateral sclerosis (ALS) experience cognitive dysfunction, whilst depression and anxiety are reported in up to 44% and 33%, respectively. These symptoms impact on quality of life, and are associated with a poorer prognosis. Historically, outcomes in clinical trials have focused on the effect of candidate drugs on physical functioning.

methodsWe reviewed the past 25 years of clinical trials of investigative medicinal products in people with ALS, since the licensing of riluzole, and extracted data on frequency and type of assessment for neuropsychiatric symptoms and cognitive impairment. Trial registry databases, including WHO International Trials Registry, European Clinical Trials Register, clinicaltrials.gov, and PubMed, were systematically searched for Phase II, III or IV trials registered, completed or published between 01/01/1994 and 31/10/2019. No language restrictions were applied. Outcome measures, exclusion criteria and assessment tool used were extracted.

results216 trials, investigating 26,326 people with ALS, were reviewed. 35% assessed neuropsychiatric symptoms, and 22% assessed cognition, as Exclusion Criteria or Outcome Measures. 3% (n = 6) of trials assessed neuropsychiatric symptoms as a Secondary Outcome Measure, and 4% (n = 8) assessed cognition as Outcome Measures; only one trial included assessments for both cognition and neuropsychiatric symptoms as Outcome Measures. Three ALS-specific assessments were used in six trials.

conclusionsTrials for people with ALS have neglected the importance of neuropsychiatric symptoms and cognitive impairment. Evaluation of these extra-motor features is essential to understanding the impact of candidate drugs on all symptoms of ALS. PROPSERO REGISTRATION: CRD42020175612.

Indexed as

Amyotrophic Lateral SclerosisMotor Neuron DiseaseCognitionHumansQuality of LifeRiluzoleRiluzoleAmyotrophic lateral sclerosisClinical trialsCognitionMotor neuron diseaseNeuropsychiatric

Identifiers

PMID32910255
PMCPMC8563523
OpenAlexW3086772010

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.