Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol

IntroductionThe development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials ha...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:BMJ open 2024-06, Vol.14 (6), p.e081541
Hauptverfasser: Kysh, Lynn, Zapotoczny, Grzegorz, Manzanete, Lisa, Carey, Megan, Shah, Payal, Joseph, Francesca, Kempf, Haley, Sikder, Abu Taher, Finkel, Julia, Thekkedath, Usha, Toman, Kara, Koh, Chester J, Eskandanian, Kolaleh, Espinoza, Juan
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:IntroductionThe development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature.Methods and analysisThe following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0–21 years) and involve human premarket or postmarket research. All study types that were published in 2007–present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis.Ethics and disseminationThis research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC.Study registrationOpen Science Framework (https://osf.io/k72bn).
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-081541