Assessment of the Reporting Quality of Randomized, Controlled Trials of Percutaneous Patent Foramen Ovale Closure for the Treatment of Migraine Based on the CONSORT Statement.

Eirini Beneki, Kyriakos Dimitriadis, Elias Zintzaras, Panagiotis Kostakis, Constantina Aggeli, Konstantinos Tsioufis

Abstract read

In one paragraph

Article in Innovations in clinical neuroscience. 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

6 authors.

Eirini BenekiDrs. Beneki, Dimitriadis, Kostakis, Aggeli, and Tsioufis are with First Cardiology Department, School of Medicine, Hippokration General Hospital, National and Kapodistrian University of Athens in Athens, Greece.

Kyriakos DimitriadisDrs. Beneki, Dimitriadis, Kostakis, Aggeli, and Tsioufis are with First Cardiology Department, School of Medicine, Hippokration General Hospital, National and Kapodistrian University of Athens in Athens, Greece.

Elias ZintzarasDr. Zintzaras is with Department of Biomathematics, University of Thessaly School of Medicine in Larissa, Greece; Center for Clinical Evidence Synthesis, The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine in Boston, Massachusetts; Pharmacology and Drug Development Program, Sackler School of Graduate Biomedical Sciences, Tufts University School of Medicine in Boston, Massachusetts.

Panagiotis KostakisDrs. Beneki, Dimitriadis, Kostakis, Aggeli, and Tsioufis are with First Cardiology Department, School of Medicine, Hippokration General Hospital, National and Kapodistrian University of Athens in Athens, Greece.

Constantina AggeliDrs. Beneki, Dimitriadis, Kostakis, Aggeli, and Tsioufis are with First Cardiology Department, School of Medicine, Hippokration General Hospital, National and Kapodistrian University of Athens in Athens, Greece.

Konstantinos TsioufisDrs. Beneki, Dimitriadis, Kostakis, Aggeli, and Tsioufis are with First Cardiology Department, School of Medicine, Hippokration General Hospital, National and Kapodistrian University of Athens in Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The presence of patent foramen ovale (PFO) has been associated with migraine. Several retrospective, nonrandomized studies support reduction of migraine frequency and severity after PFO closure. However, three randomized, controlled trials (RCTs) have not met their primary efficacy endpoints, and their reporting quality has not been assessed. The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist. Systematic searches of two databases (MEDLINE/PubMed and Cochrane Library) were conducted. The primary objective was to establish the mean CONSORT adherence of RCTs of PFO closure for the migraine treatment, and secondary objectives were the calculation of adherence per CONSORT item and the effect of CONSORT statement in high-ranked medical journals. A 37-item questionnaire based on the CONSORT 2010 checklist was used to assess the reporting quality. Adequate adherence to the CONSORT statement was defined as reporting over 70 percent of the items. The search identified three eligible articles for analysis. The mean adherence was 69.66±4.49 percent. Only one of the studies achieved a good reporting quality (≥75%). Twenty-six of the 37 items of the CONSORT checklist (70.3%) were reported in more than half of the studies. Quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains unsatisfactory. Further improvement of reporting quality is essential to assess the validity of clinical research.

Indexed as

CONSORTmigrainepatent foramen ovale closurequalityrandomized controlled trials

Identifiers

PMID40213122

PMCPMC11980908

What OpenQuestion holds

Textmetadata

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 OpenQuestion graph.