User-Centered Development of an Online Platform for Drug Dosing Recommendations in Pediatrics

Abstract

Background Drug therapy in pediatric patients is a complex process. Children are subject to continuous growth and variation in drug-metabolizing enzyme activity, requiring continuous adaption of dosages. In Germany, currently no publicly available database exists that provides evidence-based information on drug dosages in pediatrics. For local drug dosing support, a prototype database has been developed within the Children's Hospital, Erlangen. A user-centered development process was initiated to establish an online platform for evidence-based dosing recommendations, as well as pharmacological and pharmaceutical drug information in pediatrics.

Objectives The objectives of the study were to survey the demand for such a platform and to assess the usability of the different versions of the developed system.

Methods The developed prototype was evaluated in a pluralistic walkthrough with prospective end users. After a redesign, the second prototype of the online platform underwent an online usability testing based on a tailored questionnaire and the System Usability Scale (SUS) (n = 12).

Results Eleven of 12 participants expressed a demand for an online platform for pediatric dosing recommendations. The majority of the participants requested the integration of extended features, such as drug–drug interaction alerts, or information on adverse effects, pharmacokinetics, and pharmacodynamics. Particularly noteworthy is the demand for an online calculator; 5 of a total of 15 participants explicitly requested a calculator for dosages (based on age, weight, body surface) and glomerular filtration rate. The usability of the second prototype was rated “good to excellent” with a median SUS of 81.25.

Conclusion Local domain experts demand an online platform for pediatric dosing recommendations. The application of the user-centered design approach enabled the development of a prototype suitable for practical use. Multiple additional required functionalities have been identified, whereby the importance of an online calculator for patient–individual dosing recommendations was particularly emphasized.

Keywords

decision support techniques - drug therapy - computer-assisted - online systems - knowledge bases - pediatric dosages

Protection of Human and Animal Subjects

Ethical approval was not required.

• References

• 1 de Wildt SN, Tibboel D, Leeder JS. Drug metabolism for the paediatrician. Arch Dis Child 2014; 99 (12) 1137-1142
• 2 Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med 2003; 349 (12) 1157-1167
• 3 Wimmer S, Rascher W, McCarthy S, Neubert A. The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans. Paediatr Drugs 2014; 16 (05) 397-406
• 4 Knopf H, Wolf I-K, Sarganas G, Zhuang W, Rascher W, Neubert A. Off-label medicine use in children and adolescents: results of a population-based study in Germany. BMC Public Health 2013; 13: 631
• 5 Conroy S, Choonara I, Impicciatore P. , et al; European Network for Drug Investigation in Children. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000; 320 (7227): 79-82
• 6 Bücheler R, Meisner C, Kalchthaler B. , et al. “Off-label” Verschreibung von Arzneimitteln in der ambulanten Versorgung von Kindern und Jugendlichen1. Dtsch Med Wochenschr 2002; 127 (48) 2551-2557
• 7 Mühlbauer B, Janhsen K, Pichler J, Schoettler P. Off-label use of prescription drugs in childhood and adolescence: an analysis of prescription patterns in Germany. Dtsch Arztebl Int 2009; 106 (03) 25-31
• 8 Kimland E, Odlind V. Off-label drug use in pediatric patients. Clin Pharmacol Ther 2012; 91 (05) 796-801
• 9 van der Zanden TM, de Wildt SN, Liem Y, Offringa M, de Hoog M. ; Dutch Paediatric Pharmacotherapy Expertise Network NKFK (Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen). Developing a paediatric drug formulary for the Netherlands. Arch Dis Child 2017; 102 (04) 357-361
• 10 Toni I, Wimmer S, Rascher W, Neubert A. AVOID – Kann eine elektronische Patientenkurve mit Dosierungsrechner die Arzneimitteltherapiesicherheit in der Pädiatrie erhöhen?. Arzneiverordnung in der Praxis. 2018; 45: 46
• 11 International Standards Organization. Ergonomics of Human-System Interaction—Part 210: Human Centred Design for Interactive Systems, ISO 9241–210; 2010
• 12 Bhutkar G, Konkani A, Katre D, Ray GG. A review: healthcare usability evaluation methods. Biomed Instrum Technol 2013; ;(Suppl): 45-53
• 13 Kushniruk AW, Patel VL. Cognitive and usability engineering methods for the evaluation of clinical information systems. J Biomed Inform 2004; 37 (01) 56-76
• 14 Shneiderman B. Designing the User Interface: Strategies for Effective Human-Computer Interaction. 3rd ed. Reading, MA: Addison-Wesley; 1998
• 15 Nielsen J. Usability Engineering. Amsterdam: Kaufmann; 2010
• 16 Brooke J. SUS: a retrospective. J Usability Stud 2013; 8: 29-40
• 17 Finstad K. The System Usability Scale and non-native English speakers. J Usability Stud 2006; 1: 185-188
• 18 Brooke J. SUS – a quick and dirty usability scale. In: Jordan PW, Thomas B, McClelland IL, Weerdmeester B. , eds. Usability Evaluation in Industry. Boca Raton, FL: Chapman and Hall/CRC; 1996: 189-194
• 19 Brunner J, Chuang E, Goldzweig C, Cain CL, Sugar C, Yano EM. User-centered design to improve clinical decision support in primary care. Int J Med Inform 2017; 104: 56-64
• 20 Tippey KG, Weinger MB. User-centered design means better patient care. Biomed Instrum Technol 2017; 51 (03) 220-222
• 21 Luna DR, Rizzato Lede DA, Otero CM, Risk MR, González Bernaldo de Quirós F. User-centered design improves the usability of drug-drug interaction alerts: Experimental comparison of interfaces. J Biomed Inform 2017; 66: 204-213
• 22 Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatr 1984; 104 (06) 849-854
• 23 Schwartz GJ, Haycock GB, Edelmann Jr CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976; 58 (02) 259-263
• 24 Dufendach KR, Eichenberger JA, McPheeters ML. , et al. Core Functionality in Pediatric Electronic Health Records. Rockville, MD: Agency for Healthcare Research and Quality; 2015
• 25 Medizinproduktegesetz in der Fassung der Bekanntmachung vom 7. August 2002 (BGBl. I S. 3146), das zuletzt durch Artikel 7 des Gesetzes vom 18. Juli 2017 (BGBl. I S. 2757) geändert worden ist
• 26 DIRECTIVE 95/46/EC of the European Parliament and of the Council. Available at: https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=celex%3A31995L0046 . Accessed August 21, 2018
• 27 Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen (NKFK). Available at: https://www.kinderformularium.nl/ . Accessed August 21, 2018
• 28 Universitäts-Kinderspital Zürich. Kinderdosierungen.ch. Available at: https://kispiportal.uzh.ch/kinderdosierungen/D/HOMEpage_Kinderdosierungen_HOME.html . Accessed August 21, 2018
• 29 Bias RG. The pluralistic usability walkthrough: coordinated empathies. In: Nielsen J, Mack RL. , eds. Usability Inspection Methods. New York: John Wiley & Sons; 1994: 63-76
• 30 Riihiaho S. The pluralistic usability walk-through method. Ergon Des 2002; 10: 23-27
• 31 Virzi R. Streamlining the design process: running fewer subjects. In: Proceedings of the Human Factors Society Annual Meeting: SAGE Publications; 1990: 291-294
• 32 Virzi R. Refining the test phase of usability evaluation: how many subjects is enough?. Hum Factors 1992; 34: 457-468
• 33 Nielsen J, Landauer T. A mathematical model of the finding of usability problems. In: Proceedings of the INTERACT'93 and CHI'93 Conference on Human Factors in Computing Systems: ACM; 1993: 206-213
• 34 Nielsen J, Molich R. Heuristic evaluation of user interfaces. In: Proceedings of the SIGCHI Conference on Human Factors in Computing Systems: ACM; 1990: 249-256
• 35 Tullis TS, Stetson JN. A Comparison of Questionnaires for Assessing Website Usability. In: Usability Professional Association Conference. Minnesota, Minneapolis; 2004
• 36 Ateya MB, Aiyagari R, Moran C, Singer K. Insulin bolus calculator in a pediatric hospital. Safety and user perceptions. Appl Clin Inform 2017; 8 (02) 529-540
• 37 Kim GR, Chen AR, Arceci RJ. , et al. Error reduction in pediatric chemotherapy: computerized order entry and failure modes and effects analysis. Arch Pediatr Adolesc Med 2006; 160 (05) 495-498