Evidence map›Paper›PMID 32192353›Full record

ReviewThe Journal of asthma : official journal of the Association for the Care of Asthma2021

The asthma evidence base: a call for core outcomes in interventional trials.

Vickram Tejwani, Hsing-Yuan Chang, Annie P Tran, Rachael M Moloney, Sumita B Khatri

Open access · greenAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Journal of asthma : official journal of the Association for the Care of Asthma, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.8field-weighted citation impact, top 11% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Targeting interleukin-33 and thymic stromal lymphopoietin pathways for novel pulmonary therapeutics in asthma and COPD.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  3. 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

5 authors at 3 institutions in 1 country.

Vickram TejwaniPulmonary and Critical Care, Johns Hopkins Hospital, Baltimore, MD, USA.ORCID 0000-0003-2100-6148
Hsing-Yuan ChangCenter for Medical Technology Policy, Baltimore, MD, USA.ORCID 0000-0002-2927-510X
Annie P TranCenter for Medical Technology Policy, Baltimore, MD, USA.ORCID 0000-0002-8215-2555
Rachael M MoloneyCenter for Medical Technology Policy, Baltimore, MD, USA.ORCID 0000-0001-7450-906X
Sumita B KhatriRespiratory Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0002-8270-3695
Center for Medical Technology Policy · USCleveland Clinic · USJohns Hopkins Hospital · US

Funding

Macrophage phenotype and COPD severityF32HL149258 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI TEJWANI, VICKRAM · 2019 to 2020
$145k
NHLBI NIH HHS F32 HL149258
6 · The paper itself

Abstract

objectivesBiologic therapies are emerging as an option to treat a subset of patients with severe asthma, however no direct comparison between these agents has been conducted. Furthermore, heterogeneity of outcomes in clinical trials makes it difficult to compare these agents and traditional therapies. The extent to which this heterogeneity exists has major implications for evidence-based decisions and is yet to be fully reported. We conducted a literature search to examine outcomes currently being used in clinical trials for asthma. DATA SOURCES: The Cochrane Library and Clinicaltrials.gov were searched for clinical trials of asthma interventions. STUDY SELECTIONS: We limited our search to phase 2 through 4 clinical trials in adults, as early-phase trials tend to have pharmacodynamic and pharmacokinetic endpoints as primary outcomes. Interventions for acute exacerbations were excluded.

resultsWe identified 117 studies and subsequently identified 111 outcomes. The most prevalent outcomes were asthma control and symptom severity, FEV1, and change in ACQ scale. Twenty patient-reported outcomes instruments were identified and de-facto standard asthma outcomes and PROs were under-reported in examined literature. Existing quality of life tools did not capture the day-to-day experience or the unique treatment burden from oral corticosteroids for patient with severe asthma. Compounding the absence of trials directly comparing therapies, the significant variation we identified in outcome definitions and measurement create hurdles to effectively compare traditional and biologic therapies.

conclusionWith the growing number of clinical trials evaluating advanced therapies such as biologics, a wide range of primary and secondary outcomes are evaluated. A core outcome set created by relevant stakeholders is needed to collectively evaluate pooled outcomes in order to allow more meaningful comparisons of asthma therapies and to incorporate the patient experience.

Indexed as

Quality of LifeResearch DesignRespiratory Function TestsAsthmaBiological ProductsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicEndpoint DeterminationHumansPatient Reported Outcome MeasuresSeverity of Illness IndexTreatment OutcomeBiological ProductsQuality of LifeReviews

Identifiers

PMID32192353
PMCPMC7961946
OpenAlexW3012331967

What OpenQuestion holds

Textmetadata
LicenceTDM
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.