SynthesisHealth and quality of life outcomes2015
A meta-analysis of four randomized clinical trials to confirm the reliability and responsiveness of the Shortness of Breath with Daily Activities (SOBDA) questionnaire in chronic obstructive pulmonary disease.
Synthesis in Health and quality of life outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 2 papers.
What it found
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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.
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.
A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 and With Tiotropium Over 24 Weeks in Subjects With COPD
A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD
Who cites it
2 citing papers in PubMed.
- A retrospective study on the predictive efficacy of SOBDA and VSRQ scales for prognosis in elderly COPD patients.Medicine · 2025Observational
- Chronic Obstructive Pulmonary Disease Individualized Therapy: Tailored Approach to Symptom Management.Advances in therapy · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic obstructive pulmonary disease (COPD) is characterized by non-reversible airflow limitation. A common symptom of COPD is dyspnea or shortness of breath. Dyspnea may vary daily, with a large impact on patients' lives. Previous clinical trials used patient-reported outcome (PRO) measures that quantified dyspnea at discrete intervals and hence did not reflect this variability. Recently the Shortness of Breath with Daily Activities (SOBDA) questionnaire was developed as a PRO measure of dyspnea utilizing a daily diary. This confirmatory post hoc meta-analysis of SOBDA data from a large clinical study program further supports the questionnaire and clarifies the minimum threshold of SOBDA response.
methodsData from four clinical trials (DB2113361, NCT01313637; DB2113373, NCT01313650; DB2113360, NCT01316900; DB2113374, NCT01316913) were analyzed. These 24-week trials were randomized, blinded studies investigating the efficacy and safety of several COPD treatments. These post hoc analyses focused on the SOBDA questionnaire properties. This electronic-diary consists of 13 items completed daily, in which patients rate their breathlessness level during common daily activities. Resultant SOBDA scores were compared with related, commonly used assessments: modified Medical Research Council Research Dyspnea Scale (mMRC), Baseline Dyspnea Index (BDI), Transition Dyspnea Index (TDI), St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and trough forced expiratory volume in 1 s (FEV1). The consistency, reliability, validity (convergent, known groups), and responsiveness of the SOBDA questionnaire was assessed.
resultsIn total, 4967 patients with COPD provided data for these analyses. The SOBDA questionnaire had high internal consistency (Cronbach's alpha = 0.936), high test-retest reliability (Pearson's correlation coefficient = 0.86) and convergent validity with related measures (SGRQ total score, Pearson's correlation coefficient = 0.59; CAT, Spearman rank-order correlation coefficient = 0.50). SOBDA scores were statistically significantly lower in responders (as defined by TDI, SGRQ, CAT, and trough FEV1 levels) versus non-responders (p < 0.001 for all assessments and all time points). Using an anchor-based method, the threshold of a minimum response was calculated as a SOBDA score change of -0.2 (SOBDA score range = 1-4).
conclusionsThe reliability, validity, and responsiveness of the SOBDA questionnaire as a PRO measure to quantify dyspnea was supported in a large clinical trial population of patients with moderate-very severe COPD.
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Registered trials
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.