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Development of the ...
Development of the PREMature Infant Index (PREMII™), a clinician-reported outcome measure assessing functional status of extremely preterm infants
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- Ward, Robert M. (author)
- University of Utah
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- Turner, Mark A. (author)
- University of Liverpool
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- Hansen-Pupp, Ingrid (author)
- Lund University,Lunds universitet,Neonatologi,Forskargrupper vid Lunds universitet,Neonatology,Lund University Research Groups,Skåne University Hospital
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- Higginson, Jason (author)
- East Carolina University
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- Vanya, Magdalena (author)
- Patient Centered Outcomes, ICON, US
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- Flood, Emuella (author)
- Patient Centered Outcomes, ICON, US
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- Schwartz, Ethan J. (author)
- Patient Centered Outcomes, ICON, US
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- Doll, Helen A. (author)
- Patient Centered Outcomes, ICON, UK
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- Tocoian, Adina (author)
- Takeda Pharmaceuticals International
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- Mangili, Alexandra (author)
- Takeda Pharmaceuticals International
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- Barton, Norman (author)
- Takeda Pharmaceutical Company Ltd, US
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- Sarda, Sujata P. (author)
- Takeda Pharmaceutical Company Ltd, US
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(creator_code:org_t)
- 2020-03-05
- 2022
- English.
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In: Journal of Maternal-Fetal and Neonatal Medicine. - : Informa UK Limited. - 1476-7058 .- 1476-4954. ; 35:5, s. 941-950
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
Keyword
- Clinician-reported outcome measure
- extremely premature
- functional status
- infant
- outcome assessment
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Ward, Robert M.
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Turner, Mark A.
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Hansen-Pupp, Ing ...
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Higginson, Jason
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Vanya, Magdalena
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Flood, Emuella
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show more...
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Schwartz, Ethan ...
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Doll, Helen A.
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Tocoian, Adina
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Mangili, Alexand ...
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Barton, Norman
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Sarda, Sujata P.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Pediatrics
- Articles in the publication
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Journal of Mater ...
- By the university
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Lund University