Evidence map›Paper›PMID 37179537›Full record

ReviewThe World Allergy Organization journal2023

Patient-important outcomes in clinical trials of atopic diseases and asthma in the last decade: A systematic review.

Sandra Nora González-Díaz, Mariano García-Campa, Andrés Noyola-Pérez, Rosa-Ivett Guzmán-Avilán, Cindy Elizabeth de Lira-Quezada, Neri Álvarez-Villalobos, René Rodríguez-Gutiérrez, Carlos Macouzet-Sánchez

Abstract readReview
In one paragraph

Review in The World Allergy Organization journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Sandra Nora González-DíazUniversidad Autónoma de Nuevo León, Centro Regional de Alergia e Inmunología Clínica, Hospital Universitario "Dr. José Eleuterio González", Francisco I. Madero Avenue, Mitras Centro, ZC 64460, Monterrey, Mexico.
Mariano García-CampaUniversidad Autónoma de Nuevo León, Centro Regional de Alergia e Inmunología Clínica, Hospital Universitario "Dr. José Eleuterio González", Francisco I. Madero Avenue, Mitras Centro, ZC 64460, Monterrey, Mexico.
Andrés Noyola-PérezUniversidad Autónoma de Nuevo León, Centro Regional de Alergia e Inmunología Clínica, Hospital Universitario "Dr. José Eleuterio González", Francisco I. Madero Avenue, Mitras Centro, ZC 64460, Monterrey, Mexico.
Rosa-Ivett Guzmán-AvilánUniversidad Autónoma de Nuevo León, Centro Regional de Alergia e Inmunología Clínica, Hospital Universitario "Dr. José Eleuterio González", Francisco I. Madero Avenue, Mitras Centro, ZC 64460, Monterrey, Mexico.
Cindy Elizabeth de Lira-QuezadaUniversidad Autónoma de Nuevo León, Centro Regional de Alergia e Inmunología Clínica, Hospital Universitario "Dr. José Eleuterio González", Francisco I. Madero Avenue, Mitras Centro, ZC 64460, Monterrey, Mexico.
Neri Álvarez-VillalobosPlataforma Universidad Autónoma de Nuevo León, INVEST UANL-KER Unit Mayo Clinic, School of Medicine and University Hospital "Dr José E González", Monterrey 64460, Mexico.
René Rodríguez-GutiérrezPlataforma Universidad Autónoma de Nuevo León, INVEST UANL-KER Unit Mayo Clinic, School of Medicine and University Hospital "Dr José E González", Monterrey 64460, Mexico.
Carlos Macouzet-SánchezUniversidad Autónoma de Nuevo León, Centro Regional de Alergia e Inmunología Clínica, Hospital Universitario "Dr. José Eleuterio González", Francisco I. Madero Avenue, Mitras Centro, ZC 64460, Monterrey, Mexico.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Randomized Clinical Trials (RCTs) are important tools to establish the effects of a given intervention. Investigators should focus on outcomes that patients perceive: patient-important outcomes (PIOs), clinical endpoints that patients value directly and reflect how they feel, function, or survive. However, it is easier to consider surrogated outcomes to reduce costs and achieve better-looking results. The problem with these outcomes is that they indirectly measure PIOs, which might not correlate linearly or translate reliably into a positive PIO. Methods: We systematically searched MEDLINE for atopic disease RCTs rated among the top 10 allergic diseases and general internal medicine journals from the last 10 years. Two independent reviewers worked in duplicate and independently to collect data from all eligible articles. We gathered information regarding the type of study, title, author information, journal, intervention type, atopic disease, and primary and secondary outcomes. We assessed the outcomes investigators used in RCTs of atopic diseases and asthma. Results: This quantitative analysis included n = 135 randomized clinical trials. The most studied atopic disease during the period selected was asthma (n = 69), followed by allergic rhinitis (n = 51). When divided by atopic disease, primary outcomes in RCTs valuing allergic rhinitis had the most significant proportion of PIOs (76.7), asthma surrogated outcomes (38), and asthma/allergic rhinitis laboratory outcomes (42.9). PIOs in allergic rhinitis trials had the most significant proportion of PIOs favoring the intervention (81.4), asthma had the greatest proportion of surrogated outcomes (33.3), and asthma/allergic rhinitis laboratory outcomes (40). When divided by atopic disease, trials studying atopic dermatitis and urticaria had the same proportion of PIOs (64.7) as their secondary outcomes. Asthma had the highest (37.5) surrogate outcomes. Journals of general/internal medicine had a greater proportion of PIOs, and a post hoc analysis showed a significant difference in the proportion and secondary outcomes that favored the intervention between PIOs and laboratory outcomes. Conclusion: Approximately 7.5 out of 10 primary outcomes in RCTs published in general/internal medicine are PIOs compared to 5 out of 10 primary outcomes in atopic disease journals. Investigators should focus on selecting patient-important outcomes in their clinical trials to establish clinical guidelines with better-quality recommendations that impact patients' life and values. Registration: International Prospective Register of Systematic Reviews (PROSPERO, NIHR) ID: CRD42021259256.

Indexed as

Allergic rhinitisAllergyAsthmaPatient-important outcomes

Identifiers

PMID37179537
PMCPMC10172603

What OpenQuestion 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 OpenQuestion graph.