Electronic PRO Tool for Chest Congestion Created for Use in Pediatric Clinical Trials

Interviews with dozens of US children and adolescents allowed a team of researchers to develop and validate content for an electronic patient-reported outcome (PRO) tool to assess chest congestion from the common cold for eventual use in pediatric clinical trials, according to a study published online in the Journal of Patient-Reported Outcomes.

To create the tool, researchers conducted content elicitation, and later cognitive debriefing, interviews with 39 children and adolescents, ages 6 through 17, and 10 adults with current or recent colds. Additionally, 10 caregivers of children ages 6 through 8 were interviewed about their child’s ability to read and understand items.

The content elicitation interview about the experience of having chest congestion identified eight concepts for inclusion in the assessment tool: difficulty breathing; chest tightness; chest pain; chest heaviness; stuff in chest; stuffed up or clogged up; difficulty clearing mucus, and noise when breathing. For each idea, researchers drafted and tested different wording to identify the most understandable among users.

Next, participants used an electronic PRO device twice a day to answer draft items about their cold symptoms over as many as 5 days. Finally, debriefing interviews provided insight into the experience of answering each item and areas that needed revision: for instance, the term “goo” when referring to mucus was better understood than “gunk,” leading to the latter’s deletion.

Reporting symptoms using the electronic PRO device diary took users less than 3 minutes, the study found.

Ten items were included in the finalized conceptual framework of the PRO diary. The items were deemed relevant and well understood by participants across age groups.

“The items selected for taking into psychometric validation aim to assess all relevant symptom concepts associated with chest congestion,” researchers wrote, “and have the potential to be included in efficacy studies of chest congestion treatments in children, adolescents, or adults with symptoms of the common cold.”

Reference: 

Arbuckle R, Marshall C, Grant L, Burrows K, Albrecht HH, Shea T. Development and content validity testing of patient-reported outcome (PRO) items to assess chest congestion associated with the common cold for use in children and adolescents. J Patient Rep Outcomes. Published online May 28, 2022. doi:10.1186/s41687-022-00465-8