2018 Section 5 - Rhinology and Allergic Disorders

Lavigne et al.

TABLE 1. Study schedule of assessments

Assessments

Screening Implant

Day 7 Day 14 Day 21 Day 30 Day 45 Day 60 Day 90 Month 6

Informed consent, medical history, and physical

X

Assess whether patient indicated for revision ESS

X

X

SNOT-22

X

X

X

X

X

X

X

X

Concomitant medications

X

X

X

X

X

X

X

X

X

Review of adverse events

X

X

X

X

X

X

X

X

X

Endoscopic grading by clinician

X

X

X

X

X

X

X

X

X

ESS = functional endoscopic sinus surgery; SNOT-22 = 22-item Sino-Nasal Outcomes Test.

Safety was assessed by monitoring for device-related ad- verse events.

could range from 0 to 5. Patients were also asked about their perceptions of the in-office procedure and whether they would choose to have it again.

Endoscopic assessments Device performance and sinus evaluations were assessed by endoscopic examination. The evaluations were instan- taneous on the day of each study visit and all endoscopic examinations were recorded. Prior to participation, clini- cians participated in a training session on endoscopic grad- ing that included photographic examples. A standardized case report form, containing endoscopic parameters that have been previously studied, was used for the endoscopic grading (Fig. 2). 4–7 The percentage of stent remaining was also visually estimated at each time point. Patient reported outcomes Patients were asked to assess their sinusitis symptoms using the SNOT-22. The scores were analyzed in a normalized manner, meaning that the total possible score for a patient

Surgical and medical interventions Clinicians reassessed patients using the same methodology as was done at study entry to determine whether they still met the criteria for revision surgery at 6 months. The cri- teria included whether the patients reported at least 2 of the hallmark chronic rhinosinusitis (CS) symptoms (nasal obstruction/blockage, postnasal discharge, thick nasal dis- charge, altered sense of smell/taste, facial pain/pressure) de- spite ongoing use of their topical intranasal spray, and had endoscopic findings consisting of persistent obstructive mu- cosal edema or bilateral polyposis (with 1 side being at least grade 2). The planned analysis related to medical interventions consisted of adverse event reporting and tabulation of

FIGURE 2. Representative endoscopic grading form. VAS for percent ethmoid sinus obstruction (not to scale in figure) is anchored as 0 = no obstruction and 100 mm = complete obstruction of ethmoid sinus by polyps/mucosal edema. Polyps graded as 0 = none; 1 = small amount of NPs confined to MM (clinically insignificant, not requiring treatment); 2 = expanded amount of NP confined to MM; 3 = NP extending beyond MM, within sphenoethmoid recess but not totally obstructing, or both; 4 = NP completely obstructing nasal cavity. Adhesions are graded as 0 = none; 1 = small but nonobstructing; 2 = obstructing but easily separated; 3 = dense and obstructing and separation is difficult; 4 = severe with complete adhesion of the middle turbinate to lateral nasal wall. MM = middle meatus; NP = nasal polyps; VAS = visual analogue scale.

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