Evidence map›Paper›PMID 32801678›Full record

ReviewInternational journal of chronic obstructive pulmonary disease2020

Patient-Reported Outcomes (PROs) in COPD Clinical Trials: Trends and Gaps.

Nuzhat Afroz, Florian S Gutzwiller, Alex J Mackay, Christel Naujoks, Francesco Patalano, Konstantinos Kostikas

Abstract readReview
In one paragraph

Review in International journal of chronic obstructive pulmonary disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–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

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  9. Reply to CurrowAmerican journal of respiratory and critical care medicine · 2025
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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.

Nuzhat AfrozPatient Access Services, Novartis Healthcare Private Limited, Hyderabad, India.ORCID 0000-0002-3048-2704
Florian S GutzwillerGlobal Patient Access, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0001-7754-5744
Alex J MackayNational Heart and Lung Institute, Imperial College London, London, UK.
Christel NaujoksGlobal Patient Access, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-3799-6521
Francesco PatalanoClinical Development and Analytic, Global Drug Development, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0001-7015-6084
Konstantinos KostikasRespiratory Medicine Department, University of Ioannina, Ioannina, Greece.ORCID 0000-0003-0774-3942

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Key characteristics of chronic obstructive pulmonary disease (COPD) that significantly affect health-related quality of life (HRQoL) include chest symptoms, dyspnea, cough, sputum production, and exacerbations. Additional areas of impact are sleep, fatigue, emotional well-being, social functioning, and coping. Patient-reported outcomes (PROs) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response. This review summarizes COPD-specific PRO endpoints from randomized controlled trials of approved and commonly used COPD drugs. A search conducted in "ClinicalTrials.gov" to identify COPD clinical trials (only completed Phase III and IV) incorporating PRO endpoints yielded a total of 104 clinical trials for inclusion in this analysis. Both symptom-based and HRQoL-specific PRO measures were reported. Several COPD-specific PRO measures are available; however, the St. George's Respiratory Questionnaire (SGRQ) and the Baseline and Transition Dyspnea Indexes (BDI/TDI) were reported in the majority of the studies. Results reflected a gap in terms of full coverage of key impacted areas from a patient's perspective. Methodological issues identified in this review related to scoring of instruments require careful consideration, as these challenges may limit the complete assessment of drug benefits. Selection of PRO measures aligned with the expected treatment benefit of a drug in a clinical trial should reflect patients' perspective holistically.

Indexed as

Pulmonary Disease, Chronic ObstructiveQuality of LifeActivities of Daily LivingDisease ProgressionHumansPatient Reported Outcome Measureschronic obstructive pulmonary diseaseclinical trialsendpointsPatient-Focused Drug Developmentpatient-reported outcomesrandomized controlled trials

Identifiers

PMID32801678
PMCPMC7398869

What OpenQuestion holds

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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.