Photo Credit: Jacob Wackerhausen

Interviewing patients on PROMs may improve outcomes in chronic rhinosinusitis with nasal polyps, according to findings from a recent interview study.

A patient-reported outcome (PRO) measure consisting of 5 verbal response scales to assess symptoms of chronic rhinosinusitis with nasal polyps (CRSwNP) was well understood by patients and focused on the most relevant symptoms they experienced, according to a study published online in the Journal of Patient-Reported Outcomes.

PRO measures that rely on verbal descriptors, rather than 0-to-10 visual analog scales, can make it easier for patients to differentiate between response items, the study team noted.

“Recent guidance from the [US FDA] has recommended that co-primary endpoints for clinical trials include PRO measures for the assessment of nasal congestion using a verbal response scale (VRS), with 4 levels (often scored from 0 to 3) that can be clearly defined and represent clinically meaningful and distinct response categories such as ‘no symptoms,’  ‘mild symptoms,’ ‘moderate symptoms,’ and ‘severe symptoms,’” the researchers wrote.

Study Parameters

The qualitative, semi-structured interview study included 24 adults with confirmed moderate-to-severe CRSwNP from the US, Germany, and China. The researchers were interested in confirming the validity of VRS content as well as gauging what constituted a meaningful change in symptoms.

Each 60-minute interview included a concept elicitation portion and a cognitive debriefing portion. The former included questions about living with CRSwNP, and the latter touched on the patient’s views about the content of the VRS.

Improved Outcomes With Verbal Response Scale

Key symptoms reported by patients in interviews aligned with the five items selected for inclusion in the VRS: nasal obstruction, runny nose, mucus in the throat, loss of smell, and facial pain/pressure, the researchers reported. The items were relevant to most participants’ experiences with CRSwNP and its impact on daily life.

“Participants demonstrated a good understanding of the VRS items, were satisfied with the length of time taken to complete the measure, and deemed the daily assessment and recall of 24 hours appropriate and feasible to complete in a clinical trial setting,” the study authors wrote.

Regarding what would constitute a meaningful change in symptom severity, a one-category within-person improvement on an item was most frequently cited by participants as meaningful, according to the study. The indicator was consistent across all five VRS items.