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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. ; Hansen-Pupp, Ingrid LU orcid ; Higginson, Jason ; Vanya, Magdalena ; Flood, Emuella ; Schwartz, Ethan J. ; Doll, Helen A. ; Tocoian, Adina and Mangili, Alexandra , et al. (2022) In Journal of Maternal-Fetal and Neonatal Medicine 35(5). p.941-950
Abstract

Background: 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). Objectives: To develop the PREMature Infant Index (PREMII™), 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. Methods: We developed the PREMII... (More)

Background: 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). Objectives: To develop the PREMature Infant Index (PREMII™), 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. Methods: 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 via an online clinician survey. Results: 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. Conclusions: 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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinician-reported outcome measure, extremely premature, functional status, infant, outcome assessment
in
Journal of Maternal-Fetal and Neonatal Medicine
volume
35
issue
5
pages
941 - 950
publisher
Taylor & Francis
external identifiers
  • pmid:32138571
  • scopus:85081334007
ISSN
1476-7058
DOI
10.1080/14767058.2020.1735338
language
English
LU publication?
yes
id
cde411c1-17a4-4374-8a26-93e4f117d86d
date added to LUP
2020-04-16 16:09:59
date last changed
2024-06-12 12:53:34
@article{cde411c1-17a4-4374-8a26-93e4f117d86d,
  abstract     = {{<p>Background: 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). Objectives: 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 (&lt;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. Methods: 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 via an online clinician survey. Results: 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. Conclusions: 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.</p>}},
  author       = {{Ward, Robert M. and Turner, Mark A. and Hansen-Pupp, Ingrid and Higginson, Jason and Vanya, Magdalena and Flood, Emuella and Schwartz, Ethan J. and Doll, Helen A. and Tocoian, Adina and Mangili, Alexandra and Barton, Norman and Sarda, Sujata P.}},
  issn         = {{1476-7058}},
  keywords     = {{Clinician-reported outcome measure; extremely premature; functional status; infant; outcome assessment}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{941--950}},
  publisher    = {{Taylor & Francis}},
  series       = {{Journal of Maternal-Fetal and Neonatal Medicine}},
  title        = {{Development of the PREMature Infant Index (PREMII™), a clinician-reported outcome measure assessing functional status of extremely preterm infants}},
  url          = {{http://dx.doi.org/10.1080/14767058.2020.1735338}},
  doi          = {{10.1080/14767058.2020.1735338}},
  volume       = {{35}},
  year         = {{2022}},
}