Development of the PREMature Infant Index (PREMII™), a clinician-reported outcome measure assessing functional status of extremely preterm infants

Ward, Robert M, Turner, Mark A ORCID: 0000-0002-5299-8656, Hansen-Pupp, Ingrid, Higginson, Jason, Vanya, Magdalena, Flood, Emuella, Schwartz, Ethan J, Doll, Helen A, Tocoian, Adina, Mangili, Alexandra
et al (show 2 more authors) (2022) Development of the PREMature Infant Index (PREMII™), a clinician-reported outcome measure assessing functional status of extremely preterm infants. The Journal of Maternal-Fetal & Neonatal Medicine, 35 (5). pp. 1-10.

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<h4>Background</h4>Comprehensive measures to evaluate the effectiveness of medical interventions in extremely preterm infants are lacking. Although length of stay is used as an indicator of overall health among preterm infants in clinical studies, it is confounded by nonmedical factors (e.g. parental readiness and availability of home nursing support).<h4>Objectives</h4>To develop the PREMature Infant Index (PREMII<sup>™</sup>), an electronic content-valid clinician-reported outcome measure for assessing functional status of extremely preterm infants (<28 weeks gestational age) serially over time in the neonatal intensive care unit. We report the development stages of the PREMII, including suggestions for scoring.<h4>Methods</h4>We developed the PREMII according to US Food and Drug Administration regulatory standards. Development included five stages: (1) literature review, (2) clinical expert interviews, (3) Delphi panel survey, (4) development of items/levels, and (5) cognitive interviews/usability testing. Scoring approaches were explored <i>via</i> an online clinician survey.<h4>Results</h4>Key factors reflective of functional status were identified by physicians and nurses during development of the PREMII, as were levels within each factor to assess functional status. The resulting PREMII evaluates eight infant health factors: respiratory support, oxygen administration, apnea, bradycardia, desaturation, thermoregulation, feeding, and weight gain, each scored with three to six gradations. Factor levels are standardized on a 0-100 scale; resultant scores are 0-100. No usability issues were identified. The online clinician survey identified optimal scoring methods to capture functional status at a given time point.<h4>Conclusions</h4>Our findings support the content validity and usability of the PREMII as a multifunction outcome measure to assess functional status over time in extremely preterm infants. Psychometric validation is ongoing.

Item Type: Article
Uncontrolled Keywords: Clinician-reported outcome measure, extremely premature, functional status, infant, outcome assessment
Depositing User: Symplectic Admin
Date Deposited: 30 Mar 2020 11:13
Last Modified: 18 Jan 2023 23:56
DOI: 10.1080/14767058.2020.1735338
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