Cognitive Interviewing with Young Children to Support the Development of Patient reported outcome measures (PROMs): An Investigation of Feasibility and Methods

Introduction
Cognitive interviewing is widely used and recommended for evidencing comprehensibility of patient reported outcome measures (PROMs), yet the feasibility of conducting cognitive interviews with young children (≤7 years) is unknown. Difficulties assessing PROM comprehensibility has potential negative implications for the accurate and meaningful measurement of young children’s subjective health. This research aimed to establish the feasibility of cognitive interviewing with children aged 6-7 years to support evaluations of PROM item comprehensibility.

Methods
A systematic scoping review first explored young children’s (4-7 years) involvement in qualitative aspects of PROM development/evaluation. Next, methods of cognitive interviewing to evaluate PROM item comprehensibility were designed and pilot tested. A larger-scale cognitive interview study was conducted with 14 children aged 6-7 years. Data was analysed using a novel Comprehensibility Continuum developed iteratively alongside data collection to address shortcomings in existing approaches to cognitive interview analysis. Finally, an observational survey study explored current opinions of PROM developers regarding children’s involvement in qualitative aspects of PROM development/evaluation.

Results
Children (6-7 years) contributed meaningful data in cognitive interviews to support evaluations of item comprehensibility; extent of comprehensibility could be determined for 83/84 (99%) item discussions using the Comprehensibility Continuum. Survey results suggest that, on average, PROM developers consider it feasible for children to participate independently in concept elicitation research and cognitive interviews from 6- and 7-years-old respectively, which is younger than current recommendations of 8 years.

Conclusion
Despite previous uncertainty, young children (6-7 years) can participate successfully in cognitive interviews; methodological challenges were addressed through simple modifications. Unlike convention, PROM developers may also consider it feasible, in principle, for children younger than 8 years to participate in qualitative aspects of PROM development/evaluation. Effort should be made to involve young children in cognitive interviews and existing recommendations require updating to support this.