Patients’ Experiences with Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results from Cognitive Interviews to Inform Assessment of Health-Related Quality of Life

Background We previously conducted a concept elicitation study on the impact of Staphylococcus aureus and Gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient’s perspective and found significant impacts on HRQoL, particularly in physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (i.e., specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections. Methods We selected a variety of measures/items from PROMIS ® (Patient-Reported Outcomes Measurement Information System ®) representing different domains. We purposefully sampled patients approximately 6-12 weeks post SAB/GNB and conducted two rounds of cognitive interviews to refine the survey by exploring patients’ understanding of items and answer selection as well as relevance for capturing HRQoL. Results We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n=10), we revised the survey. After round two of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS ® short form measures of the most salient HRQoL domains and 2 adapted questions (41 items total), which were found to adequately capture HRQoL. Conclusion We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections.