Evidence map›Paper›PMID 35466430›Full record

Trial reportHeadache2022

Evaluating the clinical utility of the patient-identified most bothersome symptom measure from PROMISE-2 for research in migraine prevention.

Richard B Lipton, Peter J Goadsby, David W Dodick, James S McGinley, Carrie R Houts, R J Wirth, Steve Kymes, Anders Ettrup, Ole Østerberg, Roger Cady and 2 more

Open access · greenAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.6field-weighted citation impact, top 6% 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

11 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. 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

12 authors at 8 institutions in 3 countries.

Richard B LiptonDepartment of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.
Peter J GoadsbyNIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital, London, UK.
David W DodickMayo Clinic, Phoenix, Arizona, USA.ORCID 0000-0002-9486-6790
James S McGinleyVector Psychometric Group, LLC, Chapel Hill, North Carolina, USA.
Carrie R HoutsVector Psychometric Group, LLC, Chapel Hill, North Carolina, USA.
R J WirthVector Psychometric Group, LLC, Chapel Hill, North Carolina, USA.
Steve KymesLundbeck LLC, Deerfield, Illinois, USA.
Anders EttrupH. Lundbeck A/S, Copenhagen, Denmark.
Ole ØsterbergH. Lundbeck A/S, Copenhagen, Denmark.
Roger CadyRK Consults, LLC, Ozark, Missouri, USA.
Messoud AshinaDanish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6218-4744
Dawn C BuseDepartment of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.
Vector (United States) · USAlbert Einstein College of Medicine · USLundbeck (Denmark) · DKDeerfield (United States) · USMayo Clinic Hospital · USOzark Christian College · USUniversity of California, Los Angeles · USUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the utility of the novel patient-identified (PI) most bothersome symptom (MBS) measure from PROMISE-2, a phase 3 trial of eptinezumab for the preventive treatment of chronic migraine.

backgroundRelief of bothersome migraine symptoms can influence satisfaction with treatment and therapeutic persistence. Understanding the impact of preventive treatment on a PI-MBS could improve clinical decision-making.

methodsIn PROMISE-2, patients with chronic migraine received eptinezumab 100, 300 mg, or placebo administered intravenously every 12 weeks for up to 2 doses (n = 1072). PI-MBS was an exploratory outcome requiring each patient to self-report their MBS in response to an open-ended question. At baseline and week 12, patients rated overall improvement in PI-MBS. The relationships among PI-MBS at week 12 and change in monthly migraine days (MMDs) from baseline to month 3 (weeks 9-12), Patient Global Impression of Change at week 12, and changes from baseline to week 12 in the 6-item Headache Impact Test total, EuroQol 5-dimensions 5-levels visual analog scale, and 36-item Short-Form Health Survey component scores were assessed.

resultsTreatment groups had similar baseline characteristics and reported a total of 23 unique PI-MBS, most commonly light sensitivity (200/1072, 18.7%), nausea/vomiting (162/1072, 15.1%), and pain with activity (147/1072, 13.7%). Improvements in PI-MBS at week 12 correlated with changes in MMDs (ρ = -0.49; p < 0.0001) and other patient-reported outcomes. Controlling for changes in MMDs, PI-MBS improvement predicted other patient-reported outcomes in expected directions. The magnitude of the standardized mean differences between placebo and active treatment for PI-MBS were 0.31 (p < 0.0001 vs. placebo) and 0.54 (p < 0.0001 vs. placebo) for eptinezumab 100 and 300 mg, respectively.

conclusionsImprovement in PI-MBS at week 12 was associated with improvement in other patient-reported outcome measures, and PI-MBS may be an important patient-centered measure of treatment benefits in patients with chronic migraine.

Indexed as

Migraine DisordersHumansNauseaPhotophobiaTreatment Outcomechronic migraineeptinezumabmost bothersome symptompatient-identified most bothersome symptom

Identifiers

PMID35466430
PMCPMC9325355
OpenAlexW4224322420

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.