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Table 4 Summary of issues and solutions during the cognitive interviews

From: Content validity of a novel patient-reported and observer-reported outcomes assessment to evaluate ocular symptoms associated with infectious conjunctivitis in both adult and pediatric populations

Issue Category Solutions
Round 1 PRO
 Interpretations of “eye discomfort” were highly variable across patients Inconsistency in interpretation Item retained without modification for further testing in round 2
 There was disagreement on whether pain and discomfort represented the same concept or should be assessed separately Inconsistency in interpretation Item retained without modification for further testing in round 2
 Itching commonly reported in concept elicitation Relevance Item on itching added for testing in round 2
Round 2 PRO
 Foreign body sensation and discharge were commonly reported in concept elicitation Relevance Items on foreign body sensation and discharge added for testing in round 3
 Participants provided various recall periods when answering questions. There was also variability in symptom severity over the course of the day Clarity in recall period 24-h recall period added for testing in round 3; participants were asked to recall symptoms/signs at their worst over a 24-h period
Round 3 PRO
 Discharge commonly reported in concept elicitation Relevance Item on discharge added for testing in round 3, but on completion of this round, discharge was removed from the final PRO to focus on symptoms only
 Interpretations of “eye discomfort” were highly variable across patients Inconsistency in interpretation Item removed from the final PRO
Round 1 ObsRO
 None
Round 2 ObsRO
 As there was variability in symptom severity over the course of the day, a 24-h recall was recommended Clarity in recall period 24-h recall period added for testing in round 3; participants were asked to recall symptoms/signs over 24-h period
Round 3 ObsRO   
 None
  1. ObsRO Observer-reported outcome, PRO Patient-reported outcome