Abstract
Lanreotide autogel/depot, a somatostatin analogue used to treat patients with acromegaly and gastroenteropancreatic neuroendocrine tumours (GEP-NETs), is currently supplied as a sterile, ready-to-use, single-dose prefilled syringe and is administered subcutaneously. To further enhance patient care, we performed several studies to i) gain insights into patient, caregiver and healthcare professional (HCP) use of the current delivery system (DS) and ii) evaluate use of a new improved DS developed from this patient-centred approach. From June 2015 to September 2016, 4 formative studies were conducted in Europe and the US in participants representing patients with acromegaly (n=33) or GEP-NETs (n=21), caregivers (n=3), nurses (n=73), and other relevant HCPs (n=2). These studies provided feedback on the current DS; identified challenges/areas for improvement; evaluated a prototype new DS; and identified critical tasks. A human factor (HF) validation study was then performed in the US and Germany (May/June 2017) to determine whether the new DS could be used safely and effectively in its intended setting. Inclusion criteria included: patients with acromegaly, or non-diagnosed participants with enlarged hands and fingers/dexterity issues and willingness to self-inject (acromegaly representatives); a caregiver of/patient with a GEP-NET, or non-diagnosed participants willing to inject self/someone else (GEP-NET representatives/caregivers). Critical tasks were assessed by asking participants to perform two injections with the new DS into their chosen site on a mannequin. Results of the HF validation study are reported. Formative study-led improvements to the new DS included: ergonomics (larger flanges to improve handling; robust over-cap to improve needle shield removal); robustness of injection process (plunger support); intuitiveness of use (tray to protect the DS and prevent accidental plunger depression; recessed areas to improve handling); needle exposure (white opaque over-cap, improved retractable needle system after injection). The HF validation study comprised US participants (N=35) (including HCPs who did [n=16] or did not [n=19] receive training prior to testing) and German participants (N=33) (including acromegaly representatives [n=15] and GEP-NET representatives/caregivers [n=18]; all received training before testing). Among HCPs, 13 task errors were noted in untrained participants and 3 in trained participants. Among German participants, 18 task errors were noted in acromegaly representatives and 16 in GEP-NET representatives/caregivers. No task errors were specific to the new DS. A new delivery system for lanreotide depot/autogel was developed in conjunction with patients, caregivers and HCPs. It is hoped that the ergonomic, robust and intuitive delivery system will further improve patient care. Sponsored by Ipsen