The evaluation of patient-reported outcomes (PROs) in healthcare has become increasingly important, with continuous advancements in methods aimed at enhancing the reliability and validity of PRO instruments. The Patient Reported Outcomes Measurement Information System (PROMIS) project, an initiative funded by the National Institutes of Health (NIH) Roadmap for Medical Research, was established to advance the science and application of PROs, particularly in the context of chronic diseases.
This paper, authored by Debra E. Irwin, James W. Varni, Karin Yeatts, and Darren A. DeWalt, details the cognitive interviewing procedures employed by the PROMIS pediatrics group. The primary objective of their study was to conduct cognitive interviews with children and adolescents, specifically those aged 8–17 years, to gather feedback on items designed to measure various crucial health domains. These domains included physical functioning, emotional health, social health, fatigue, pain, and asthma-specific symptoms. Asthma was specifically included as the most common chronic disease of childhood, making it an excellent candidate for the initial development of a disease-specific item bank.
The development of item banks for PROMIS involves a rigorous process, including literature review, focus groups, and individual cognitive interviews. Within these qualitative methods, cognitive interviewing is essential as it directly elicits input from respondents on item content, format, and understandability. This methodology assesses the cognitive processes involved in respondents’ comprehension and generation of answers to questionnaire items, seeking to understand what specific words and phrases mean to them, how they retrieve relevant information, and how they formulate their responses. For the PROMIS pediatrics study, the respondent debriefing technique was utilized, where interviewers probed participants after questionnaire completion about any difficulties encountered and the rationale behind their answers. The pediatric methodology specifically adapted general PROMIS principles for children as young as 8 years old.
A substantial effort was undertaken, involving 88 cognitive interviews with 77 children and adolescents across two sites, covering an initial pool of 318 items. From this initial set, 25 items were deleted, and 35 were revised, subsequently undergoing a second round of cognitive interviews. A key finding was that children as young as 8 years old were largely capable of comprehending the majority of items, response options, directions, and recall periods. They were also able to identify language difficulties and provide alternative wording. The cognitive interviews revealed issues with item comprehension on several items, leading to significant revisions (as detailed in Tables 4 and 5 of the source material), which improved the clarity of the items. Ultimately, 293 items were retained for subsequent field testing, confirming that children in this age range can meaningfully discuss and respond to questions about their health and well-being.
Reference for this article:
Irwin, D. E., Varni, J. W., Yeatts, K., & DeWalt, D. A. (2009). Cognitive interviewing methodology in the development of a pediatric item bank: a patient reported outcomes measurement information system (PROMIS) study. Health and Quality of Life Outcomes, 7(3), 3. https://doi.org/10.1186/1477-7525-7-3