Co-Creation of a Lanreotide Autogel/Depot Syringe for the Treatment of Acromegaly and Neuroendocrine Tumours Through Collaborative Human Factor Studies

Abstract

IntroductionAlthough the previous lanreotide autogel/depot syringe had been well received, feedback indicated that improvements could be made to make it more user-friendly. Additionally, the view that patients should have greater involvement in the research and development process is echoed by the International Neuroendocrine Cancer Alliance. A series of studies aimed to develop and validate a new syringe that works better for patients, caregivers and healthcare professionals (HCPs) by involving these groups at key stages in the development and testing process.MethodsThe multicentre, international, human factor studies, consisted of four formative studies and one validation study. The formative studies collected patient, caregiver and HCP feedback on the lanreotide autogel/depot syringe on the market at the time, and on newly designed prototypes. The validation study was conducted to evaluate the final syringe to confirm that it can be used effectively and safely in the intended environment, by the intended user, for the intended purpose.ResultsOverall, 213 individuals participated in the studies; 145 contributed to the formative studies and 68 to the validation study. The validated new-generation syringe included several important updates compared with the lanreotide autogel/depot syringe currently on the market, including the flanges, which are now larger and have a better grip; the overcap, which is white, ridged, opaque and bigger; the plunger supports and the thermoformed tray. No participant hurt themselves or others during the validation study (although several misuses were reported), and all participants succeeded in delivering a complete dose and activating the safety system.ConclusionWith collaboration, a new syringe was developed to meet the needs of patients, caregivers and HCPs, whilst ensuring lanreotide was delivered effectively and safely. These studies highlight the importance of involving patients, caregivers and HCPs in clinical evaluation studies to develop medical products that address their concerns and meet their needs.FundingIpsen.Plain Language SummaryPlain language summary available for this article.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-01112-3) contains supplementary material, which is available to authorized users.

Evaluation of Nurse Preferences Between the Lanreotide Autogel New Syringe and the Octreotide Long-Acting Release Syringe: An International Simulated-Use Study (PRESTO)

“…In a previous preference study published in 2012, nurses preferred the lanreotide autogel/depot (LAN) syringe compared with that of previous octreotide long-acting release (LAR) [7,8]. Although nurses preferred the LAN syringe overall and for nearly all syringe attributes, the sturdiness of the plunger received a higher rating for the octreotide LAR syringe [7]; this is consistent with feedback from patients, caregivers and healthcare professionals obtained during a series of formative interviewbased studies [9].…”

“…In a previous study, the overall preference score by nurse assessment was 63 percentage-points higher for the LAN previous syringe compared with the previous octreotide LAR syringe [7] and, in another study, 81% of patients who switched from octreotide LAR to LAN preferred to continue treatment with LAN [16]. Given the almost universal preference for the LAN new syringe in the PRESTO study, this suggests that the advancements made for the LAN syringe (larger flanges; a larger, more rigid non-transparent needle cap; new plunger supports; new protective tray) [9] following feedback from nurses [7] and from patients, caregivers and nurses in formative human factors studies [9] resulted in improved user experience with this new device.…”

“…Based on these previous findings, and to continue to improve patient and nurse experience, the LAN new syringe was developed to be more ergonomic and user-friendly than the previous delivery system [9]. The key changes made to this device included larger flanges (finger supports for pushing the plunger down), new plunger supports, a larger, ridged, non-transparent needle cap (previously a seethrough needle shield) and a new protective tray [9]. The present study is the first to ask experienced nurses to report their preference between the LAN new syringe and the current octreotide LAR syringe.…”

Patient and Healthcare Provider Perspectives of First-Generation Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review

“…It is interesting to consider that future studies might reveal a shift towards home-based healthcare, especially in the era of the coronavirus disease 2019 (COVID-19) pandemic, and, as such, the option for self- or partner-injection may become a more prominent feature in treatment decision-making. Furthermore, a recent study evaluating patient experience using a LAN syringe introduced in 2019 indicated that use of newer injection devices could further reduce pain and anxiety for patients [ 46 , 47 ].…”

Evaluation of the Octreotide Acetate Pen Injector and its Instructions for Use in a Formative Human Factors Study

“…Additionally, patients, patient advocates, and healthcare practitioners (HCPs) believe patients with NETs are not sufficiently involved in research supporting their treatment [ 14 ]. In a series of human factors studies, patients, HCPs, and non-HCP caregivers tested prototype syringes intended to treat acromegaly and NETs, helping to better design a user-centered device [ 15 ]. This suggests there is an opportunity to better inform treatment development with greater patient involvement.…”