Evidence map›Paper›PMID 32982203›Full record

SynthesisInternational journal of chronic obstructive pulmonary disease2020

Is the St. George's Respiratory Questionnaire an Appropriate Measure of Symptom Severity and Activity Limitations for Clinical Trials in COPD? Analysis of Pooled Data from Five Randomized Clinical Trials.

Angely Loubert, Antoine Regnault, Juliette Meunier, Florian S Gutzwiller, Stéphane A Regnier

Abstract readMeta-Analysis
In one paragraph

Synthesis 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 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. 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.

Angely LoubertModus Outcomes, Lyon, France.
Antoine RegnaultModus Outcomes, Lyon, France.ORCID 0000-0001-8234-2896
Juliette MeunierModus Outcomes, Lyon, France.ORCID 0000-0001-5372-5804
Florian S GutzwillerNovartis Pharma AG, Basel, Switzerland.ORCID 0000-0001-7754-5744
Stéphane A RegnierNovartis Pharma AG, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The objective of this study was to examine the psychometric properties of the St. George's Respiratory Questionnaire (SGRQ) in patients with chronic obstructive pulmonary disease (COPD) using Rasch measurement theory (RMT) analyses. Materials and Methods: RMT analysis was conducted on the baseline SGRQ data from five multi-national, Phase III randomized trials investigating a fixed-dose combination of a long-acting β2-agonist and a long-acting muscarinic antagonist in COPD patients. Analysis was performed for the SGRQ "Symptoms" and "Activity" domains. An exploratory analysis was also conducted using the different specific symptoms as defined in the reconceptualization of the SGRQ "Symptoms" domain. Differential item functioning (DIF) analysis was performed for geographical regions on the "Activity" domain, in order to explore cross-cultural validity of the SGRQ. Results: Overall, the SGRQ "Activity" domain showed good measurement property, but two items ("Sitting or lying still making feel breathless" and "Playing sports or game making feel breathless") showed very high fit residuals. The SGRQ "Symptoms" domain demonstrated good targeting; however, two items showed disordered thresholds ("Coughed" and "Brought up phlegm"). In an exploratory RMT analysis, measures for "Cough and Sputum", "Breathing difficulties" or "Wheezing attacks" showed unsatisfactory measurement properties with poor reliability (person separation index = 0.35, 0.66 and 0.16, respectively) and targeting issues. The examination of cross-cultural performances of the SGRQ "Activity" items showed a great variability in the responses to these items in different global regions. Conclusion: Our results indicated that SGRQ may not be an appropriate instrument to measure symptom severity or activity limitations in patients with COPD. Hence, there is a need to develop other relevant PRO instruments that can be used in conjunction with SGRQ to provide a holistic assessment of the health status of COPD patients in clinical research.

Indexed as

Pulmonary Disease, Chronic ObstructiveHumansMaleQuality of LifeRandomized Controlled Trials as TopicReproducibility of ResultsSurveys and Questionnaireshealth-related quality of lifehealth statuspatient-reported outcomespsychometric evaluationRasch measurement theory

Identifiers

PMID32982203
PMCPMC7490086

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.