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„Back on Track“: Kreuzbandstudie via Smartphone

Praxisbeispiel für die Möglichkeiten des Apple ResearchKit

Back on track: cruciate ligament study via smartphone

Practical example of possibilities for the Apple ResearchKit

  • Leitthema
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Arthroskopie Aims and scope

Zusammenfassung

Hintergrund

Im März 2015 veröffentlichte Apple Inc. „ResearchKit“, ein neuartiges Open-source-Framework, um Ärzte und Wissenschaftler weltweit in die Lage zu versetzen, klinische Studien für mobile Endgeräte einfach erstellen zu können.

Fragestellung

In dieser Arbeit wird die Entwicklung einer Studien-App („Back on Track“) basierend auf ResearchKit beschrieben. Die Fragestellung der Studie ist die Therapieentscheidung bei Patienten mit akuten Rupturen des vorderen Kreuzbands (VKB).

Material und Methode

Eine mehrsprachige Observationsstudie wurde durchgeführt. Zunächst wurden ein passendes Forschungsthema, Zielgruppen und teilnehmende Regionen identifiziert. Die App-Entwicklung erfolgte unter Verwendung des ResearchKit-Frameworks. Ein sicherer Datenserver wurde aufgesetzt und eine verschlüsselte Kommunikation sichergestellt. Konzepte für die Datenspeicherung- und Datensicherheit zur Trennung von Studiendaten und persönlichen Daten wurden entworfen. Ethische Aspekte wurden betrachtet und im Rahmen des Datenschutzes berücksichtigt.

Ergebnisse

Eine mHealth-Studie basierend auf ResearchKit wurde ohne weitreichende iOS-Programmiererfahrung entwickelt. Der Apple App-Store ist ein wesentlicher Vertriebskanal, der signifikante Downloadraten (>1200/a) ohne aktive Rekrutierung ermöglicht. Vorläufige Datenanalysen zeigen moderate Abbruchquoten und eine gute Datenqualität. Aktuell sind 180 Teilnehmer in der Studie registriert. Derzeit nehmen 107 Probanden regelmäßig teil und haben bisher 424 vollständige Fragebögen erzeugt.

Schlussfolgerung

ResearchKit ist ein einfach zu nutzendes Framework und ein umfassendes Werkzeug zur Erstellung klinischer Studien. Vorteile sind der modulare Aufbau, die hohe Verbreitung von iOS-Geräten und eine komfortable Programmierumgebung.

Abstract

Background

In March 2015 Apple Inc. presented ResearchKit, a novel open source framework allowing doctors and researchers worldwide to simply create mobile device-based healthcare studies.

Objectives

In this article the development of a study app („Back on Track“) based on ResearchKit is described. The objective of the study was the decision-making process regarding treatment in patients with acute rupture of the anterior cruciate ligament (ACL).

Methods

A multilingual observational study was conducted. Initially a suitable research topic, target groups and participating regions were carefully identified. The ResearchKit framework was used to program the app. A secure server was set up and coded communicative connections were realized. A data storage and security concept separating personal information and study data was drafted. Ethical implications were considered and taken into account regarding privacy policies.

Results

An app study based on ResearchKit was developed without comprehensive experience in iPhone operating service (iOS) programming development. The Apple App Store is a major distribution channel allowing significant download rates (>1200/year) without active recruitment. Preliminary data analysis showed moderate drop-out rates and a good quality of data. Currently, 180 participants are enrolled with 107 actively participating and 424 completed questionnaires have been produced.

Conclusion

ResearchKit is an easy to use framework and a powerful tool for creating clinical studies. Advantages are the modular construction, the extensive distribution of iOS devices and the comfortable programming environment.

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Danksagung

Die Autoren danken der Firma DESIGN-IT GmbH (Frankfurt) für die Zusammenarbeit und Unterstützung bei den Programmiertätigkeiten. Kontakt: http://researchapps.de/.

Studienregister

Die Studie wurde registriert im Deutschen Register Klinischer Studien (DRKS) – https://www.germanctr.de: DRKS00009270.

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Authors and Affiliations

  1. Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie, Hugstetter Str. 55, 79106, Freiburg, Deutschland

    M. Zens, N. P. Südkamp & P. Niemeyer

  2. IV. Medizinische Klinik und Zentrale Notaufnahme, Klinikum Augsburg, Stenglinstr. 2, 86156, Augsburg, Deutschland

    M. Zens

Authors
  1. M. Zens
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  3. P. Niemeyer
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Corresponding author

Correspondence to M. Zens.

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Interessenkonflikt

M. Zens, N.P. Südkamp und P. Niemeyer geben an, dass kein Interessenkonflikt besteht. Insbesondere hat keiner der Autoren ein finanzielles Interesse oder Beraterverträge mit Apple, Inc. oder einer Tochtergesellschaft.

Dieser Beitrag enthält keine Studien an Menschen oder Tieren.

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Zens, M., Südkamp, N.P. & Niemeyer, P. „Back on Track“: Kreuzbandstudie via Smartphone. Arthroskopie 29, 225–231 (2016). https://doi.org/10.1007/s00142-016-0098-6

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  • DOI: https://doi.org/10.1007/s00142-016-0098-6

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