The recombinant human chorionic gonadotropin prefilled pen: results of patient and nurse human factors usability testing

Abstract

Objectives: The first prefilled pen for administration of recombinant human chorionic gonadotropin (r-hCG) has been developed. Usability testing was undertaken to evaluate the risk of dosing errors versus the existing r-hCG prefilled syringe, and assess function and handling of the pen.

Methods: Infertile women who were trying to conceive, and specialist nurses, were recruited in Germany. Usability goals were defined and categorized as critical or functional operational goals. Individual, non-interventional, standardized, usability tests (including ease-of-use assessment) were performed with patients and nurses. Cumulative test scores for critical operations were compared. Non-standardized qualitative analyses of nurse–patient training sessions were performed.

Results: The cumulative test score for the r-hCG prefilled pen was better than that of the existing prefilled syringe, so it was concluded that the overall risk of dosing errors was not higher with the pen. The ease of use of the pen was rated favorably by patients and nurses. Both user groups were confident that they could inject the correct dose using the pen.

Conclusions: The overall risk of dosing errors was not higher with the r-hCG prefilled pen than the existing prefilled syringe. The ease-of-use of the r-hCG prefilled pen was rated favorably by patients and nurses.

Keywords::

• human factors
• in vitro fertilization
• infertility
• injection device
• pen injector
• recombinant human chorionic gonadotropin
• usability testing

Acknowledgments

The authors would like to thank M Christen, (Merck Serono S.A. – Geneva, Switzerland^‡ for conducting the risk assessment review, and for collaboration on the design and implementation of the pre-summative and summative usability testing, and M Hagenm, and M Beekmann for performing the nurse and patient interviews. They also thank J Davies, H Wills and C Kidd of Caudex Medical for their assistance in the preparation of this manuscript.

Notes

This box summarizes key points contained in the article.