Evidence map›Paper›PMID 32116657›Full record

ArticleFrontiers in pharmacology2019

Healthcare Professionals' Preferred Efficacy Endpoints and Minimal Clinically Important Differences in the Assessment of New Medicines for Chronic Obstructive Pulmonary Disease.

Marloes Dankers, Marjorie H J M G Nelissen-Vrancken, Sara M K Surminski, Anke C Lambooij, Tjard R Schermer, Liset van Dijk

Open access · goldAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 36% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.International journal of chronic obstructive pulmonary disease · 2024
    Trial
  3. Review
  4. Article
  5. Review
  6. 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

6 authors at 2 institutions in 1 country.

Marloes DankersDutch Institute for Rational Use of Medicine, Utrecht, Netherlands.
Marjorie H J M G Nelissen-VranckenDutch Institute for Rational Use of Medicine, Utrecht, Netherlands.
Sara M K SurminskiDutch Institute for Rational Use of Medicine, Utrecht, Netherlands.
Anke C LambooijDutch Institute for Rational Use of Medicine, Utrecht, Netherlands.
Tjard R SchermerNivel Netherlands Institute for Health Services Research, Utrecht, Netherlands.
Liset van DijkNivel Netherlands Institute for Health Services Research, Utrecht, Netherlands.
Instituut voor Verantwoord Medicijngebruik · NLNetherlands Institute for Health Services Research · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegistration authorities evaluate effects of new medicines for chronic obstructive pulmonary disease (COPD) on airway obstruction, dyspnea, health status and exacerbations. To establish clinical relevance, minimal clinically important differences (MCIDs) are used. The aim of this study was to investigate which efficacy endpoints and MCIDs healthcare professionals consider clinically relevant for new COPD medicines. MATERIALS AND

methods7,731 Healthcare professionals received an electronic questionnaire. Participants were asked for: 1) preferred efficacy endpoints for new COPD medicines and 2) cut-off values defining clinical relevance for forced expiratory volume in 1 sec (FEV

results227 Healthcare professionals responded to the questionnaire. Most preferred efficacy endpoints were exacerbations (51.0%), airway obstruction (46.9%) and health status (44.9%). Mean cut-off values for TDI and SGRQ were significantly higher than the corresponding MCIDs, mean differences 1.5 (95%CI = 1.3-1.8, p < 0.001) and 7.0 (95%CI = 5.1-8.8, p < 0.001), respectively. The mean cut-off value for FEV

conclusionsHealthcare professionals largely agree with efficacy endpoints used for the evaluation of new COPD medicines. However, they seem to prefer higher cut-off values for clinical relevance for TDI and SGRQ than the registration authorities. Effects of new medicines on TDI and SGRQ that are considered clinically relevant by registration authorities do, therefore, not necessarily reflect healthcare professionals' perspectives on clinical relevance.

Indexed as

chronic obstructive pulmonary diseaseclinical relevanceforced expiratory volume in 1 secminimal clinically important differencesnew medicinepatient-reported outcomesSt. George’s Respiratory QuestionnaireTransition Dyspnea Index

Identifiers

PMID32116657
PMCPMC7016298
OpenAlexW3004427423

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.