PRO-Surveyor: Device for Capturing Patient Reported Outcome Data in Children

DESCRIPTION (provided by applicant): Abstract Patient-reported outcomes (PROs) are a component of health-related quality of life that measure aspects of a patient's health that come directly from the patient, typically via the use of valid and reliable que stionnaires. Methods of administration are traditionally paper forms or computerized/internet methods. Each of these current methods has significant pitfalls. PROs of children, including children with communication impairments, have been understudied, due in large part to methodological issues. Presently, data collection methods are not amenable to inclusion of special populations, such as children, the chronically ill, those who do not speak English, the illiterate, or the impoverished living in remote are as. Therefore, it is beneficial to develop new methods for the collection of PRO data in special or vulnerable populations. Our goal is to develop PRO-Surveyor, a dedicated, low cost, handheld device for the collection and electronic transmission of pediat ric PRO questionnaire data. PRO-Surveyor is innovative because it employs a novel approach easily adapted to any questionnaire instrument, various response models, various modes of questionnaire administration (text, audio, video), and automatic data trans mission to the clinician or investigator from remote sites. The specific aim of Phase I is to demonstrate feasibility by investigating reproducibility of PRO measurements, efficiency of use, and acceptability of a preliminary PRO-Surveyor prototype, in com parison with traditional paper PRO measurements. We will use a preliminary prototype to collect PRO data from typically developing children and children with with speech and voice impairments, ages 8-12, and one parent per child. This milestone-driven aim will be accomplished in 4 steps: (1) design and build a working prototype of PRO-Surveyor with core functionality; (2) present the device to 5 children and parents in focused interviews; (3) modify PRO-Surveyor to incorporate results from focused interview s, and test PRO-Surveyor in 20 children, ages 8-12 using the PedsQL 4.0, a valid, reliable, and age-appropriate questionnaire that assesses perception of general health quality in children; and (4) complete data analysis and Phase I reporting. Development of new strategies for collecting PRO data in children is necessary toward the goal of obtaining an inclusive representation of treatment outcomes. While the use of computers and the internet has great promise for electronic data capture, US Census data rev ealed that many homes do not have computers or internet access, particularly homes with children and those with incomes less than 25,000 per year. Accordingly, there is a strong clinical need for innovative approaches to the collection of PRO data in chil dren. 1 PUBLIC HEALTH RELEVANCE PRO-Surveyor is an innovative, low cost, dedicated, handheld device for collecting and transmitting patient reported outcomes (PROs) from children. Development of strategies for collecting these data is very timely given new Food and Drug Administration (FDA) guidance and NIH programs (NIH PROMIS) that signal an increased focus on obtaining and understanding the patient's perspective of his/her health. Accordingly, development of improved and efficient methods for data collec tion, especially in vulnerable and typically excluded populations, such as children, is important and highly relevant to healthcare and the mission of the NIH.