Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study

Introduction: Subcutaneous injection of octreotide acetate is indicated to treat adults with acromegaly and diarrhea associated with carcinoid tumors or vasoactive intestinal peptide tumors. In this formative human factors study, we evaluated the readability and comprehension of the instructions for...

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Autores principales: Andre, Anthony, Squittieri, Nicholas, Patil, Satyashodhan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8265737/
http://dx.doi.org/10.1210/jendso/bvab048.2083
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author Andre, Anthony
Squittieri, Nicholas
Patil, Satyashodhan
author_facet Andre, Anthony
Squittieri, Nicholas
Patil, Satyashodhan
author_sort Andre, Anthony
collection PubMed
description Introduction: Subcutaneous injection of octreotide acetate is indicated to treat adults with acromegaly and diarrhea associated with carcinoid tumors or vasoactive intestinal peptide tumors. In this formative human factors study, we evaluated the readability and comprehension of the instructions for use (IFU) and ease of use of the octreotide pen injector. Methods: The study enrolled patients and healthcare practitioners who would be using the pen injector. The IFU contained a stepwise process with illustrations to detail injection administration and safe storage of the octreotide pen injector. Participants read the IFU and familiarized themselves with the device. Participants administered 2 unaided injections into skin-like pads. Injection success was defined as an attempt that delivered the correct dose into the pad. Each injection was evaluated by objective performance and subjective measures. Objective performance measures included assessment of steps necessary to deliver the correct medication dose and ensure user safety. Subjective measures included soliciting participant feedback on perceived success and difficulties administering a dose with the octreotide pen injector, as well as suggestions for improvements. Additional goals included evaluation of the IFU and octreotide pen injector usability aspects. Results: A total of 8 patients and 3 healthcare practitioners enrolled in the study. All (n = 11) participants successfully administered both injections, leading to an overall injection success rate of 100% across twenty-two injections. Subtask errors included participants priming the pen injector with the incorrect dose (n = 1) and not holding the injection button for 10 seconds after the injection (n = 2), but neither error resulted in dosing failure. Participant suggestions for improving the IFU included changes to the illustration of the plunger, reordering statements to clarify the priming process, and detailing how long to let the pen injector come to room temperature. Conclusion: Overall, participants felt the octreotide pen injector was easy to use and the instructions were clearly written and illustrated. Participant feedback and observations by moderators of the study led to recommendations for improvements to the clarity of the IFU.
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spelling pubmed-82657372021-07-09 Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study Andre, Anthony Squittieri, Nicholas Patil, Satyashodhan J Endocr Soc Tumor Biology Introduction: Subcutaneous injection of octreotide acetate is indicated to treat adults with acromegaly and diarrhea associated with carcinoid tumors or vasoactive intestinal peptide tumors. In this formative human factors study, we evaluated the readability and comprehension of the instructions for use (IFU) and ease of use of the octreotide pen injector. Methods: The study enrolled patients and healthcare practitioners who would be using the pen injector. The IFU contained a stepwise process with illustrations to detail injection administration and safe storage of the octreotide pen injector. Participants read the IFU and familiarized themselves with the device. Participants administered 2 unaided injections into skin-like pads. Injection success was defined as an attempt that delivered the correct dose into the pad. Each injection was evaluated by objective performance and subjective measures. Objective performance measures included assessment of steps necessary to deliver the correct medication dose and ensure user safety. Subjective measures included soliciting participant feedback on perceived success and difficulties administering a dose with the octreotide pen injector, as well as suggestions for improvements. Additional goals included evaluation of the IFU and octreotide pen injector usability aspects. Results: A total of 8 patients and 3 healthcare practitioners enrolled in the study. All (n = 11) participants successfully administered both injections, leading to an overall injection success rate of 100% across twenty-two injections. Subtask errors included participants priming the pen injector with the incorrect dose (n = 1) and not holding the injection button for 10 seconds after the injection (n = 2), but neither error resulted in dosing failure. Participant suggestions for improving the IFU included changes to the illustration of the plunger, reordering statements to clarify the priming process, and detailing how long to let the pen injector come to room temperature. Conclusion: Overall, participants felt the octreotide pen injector was easy to use and the instructions were clearly written and illustrated. Participant feedback and observations by moderators of the study led to recommendations for improvements to the clarity of the IFU. Oxford University Press 2021-05-03 /pmc/articles/PMC8265737/ http://dx.doi.org/10.1210/jendso/bvab048.2083 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Tumor Biology
Andre, Anthony
Squittieri, Nicholas
Patil, Satyashodhan
Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study
title Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study
title_full Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study
title_fullStr Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study
title_full_unstemmed Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study
title_short Evaluation of the Octreotide Acetate Pen Injector in a Formative Human Factors Study
title_sort evaluation of the octreotide acetate pen injector in a formative human factors study
topic Tumor Biology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8265737/
http://dx.doi.org/10.1210/jendso/bvab048.2083
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