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Clinical Trial
. 2014 Nov 1:14:169.
doi: 10.1186/1471-2466-14-169.

Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis

Affiliations
Clinical Trial

Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis

Amanda Belkin et al. BMC Pulm Med. .

Abstract

Background: Little is known about whether or how supplemental oxygen affects patients with pulmonary fibrosis.

Methods/design: A mixed-methods study is described. Patients with pulmonary fibrosis, informal caregivers of pulmonary fibrosis patients and practitioners who prescribe supplemental oxygen will be interviewed to gather data on perceptions of how supplemental oxygen impacts patients. In addition, three hundred pulmonary fibrosis patients who do not use daytime supplemental oxygen will be recruited to participate in a longitudinal, pre-/post- study in which patient-reported outcome (PRO) and activity data will be collected at baseline, immediately before daytime supplemental oxygen is initiated, and then once and again 9-12 months later. Activity data will be collected using accelerometers and portable GPS data recorders. The primary outcome is change in dyspnea from before to one month after supplemental oxygen is initiated. Secondary outcomes include scores from PROs to assess cough, fatigue and quality of life as well as the activity data. In exploratory analyses, we will use longitudinal data analytic techniques to assess the trajectories of outcomes over time while controlling for potentially influential variables.

Discussion: Throughout the study and at its completion, results will be posted on the website for our research program (the Participation Program for Pulmonary Fibrosis or P3F) at http://www.pulmonaryfibrosisresearch.org.

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Figures

Figure 1
Figure 1
Longitudinal study design.

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Pre-publication history
    1. The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2466/14/169/prepub

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