Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions.

Ioana Medrea, Stewart J Tepper, Donliang Wang, Paul G Mathew, Mark Burish

Abstract read

In one paragraph

Article in The journal of headache and pain, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Ioana MedreaSUNY Upstate Medical University, Syracuse, New York, USA. medreai@upstate.edu.

Stewart J TepperThe New England Institute for Neurology and Headache, 30 Buxton Farms Rd, Stamford, CT, USA.

Donliang WangSUNY Upstate Medical University, Syracuse, New York, USA.

Paul G MathewHarvard Medical School, Boston, MA, USA.

Mark BurishUTHealth Houston, Department of Neurosurgery, Houston, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies. MAIN BODY: We present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment.

conclusionsWe highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.

Indexed as

Cluster HeadacheClinical Trials as TopicEquivalence Trials as TopicHumansCluster headache trialFuture directions cluster headache trialsMethodology cluster headache design

Identifiers

PMID38454380

DOI10.1186/s10194-024-01732-3

PMCPMC10921584

What OpenQuestion holds

Textmetadata

LicenceCC BY

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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.