ORIGINAL RESEARCH

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

Daphne Adelman . Xuan-Mai Truong Thanh . Marion Feuilly .

Aude Houchard . David Cella

Received: January 22, 2020 / Published online: March 11, 2020� The Author(s) 2020

ABSTRACT

Introduction: Somatostatin analogues are usedto treat symptoms and slow tumour progressionin patients with neuroendocrine tumours(NETs) and carcinoid syndrome and to reducehormone secretion and pituitary tumour

volume in patients with acromegaly. A newsyringe for lanreotide autogel/depot (LAN) wasdeveloped following feedback from a humanfactors study to improve ease of injection com-pared with previous syringes. PRESTO aimed toassess preferences of nurses between the LANnew syringe and the octreotide long-actingrelease (LAR) syringe.Methods: PRESTO, a multinational, multicen-tre, prospective, noninterventional, simulated-use study, enrolled nurses with C 2 years’experience injecting LAN and/or octreotide LARin patients with NETs and/or acromegaly. Nur-ses administered injections into pads using theLAN new syringe and octreotide LAR syringe ina randomised sequence. In an anonymous web-based questionnaire, nurses reported theiroverall preference (‘strong’ or ‘slight’; primaryendpoint) and rated and ranked the importanceof nine attributes for each syringe (1 [not at all]to 5 [very much]).Results: Overall, 90 nurses attended sessionsand completed valid questionnaires. Most nur-ses (97.8%) expressed a preference (85.6%‘strong’, 12.2% ‘slight’) for the LAN new syringeversus the octreotide LAR syringe (P\ 0.0001).Attribute performance ratings (1 [not at all] to 5[very much]) were consistently higher for theLAN new syringe versus the octreotide LARsyringe, with the greatest differences in ‘fastadministration’ and ‘confidence the syringe willnot be clogged’ (mean difference [SD]: 2.6 [1.2]and 2.3 [1.5], respectively; P\ 0.0001).

Enhanced Digital Features To view enhanced digitalfeatures for this article, including a summary slide andgraphical abstract, go to https://doi.org/10.6084/m9.figshare.11806605.

Electronic Supplementary Material The onlineversion of this article (https://doi.org/10.1007/s12325-020-01255-8) contains supplementary material, which isavailable to authorized users.

D. Adelman (&)Division of Endocrinology, Metabolism andMolecular Medicine, Northwestern UniversityFeinberg School of Medicine, Chicago, IL, USAe-mail: d-adelman@northwestern.edu

X.-M. Truong ThanhGlobal Medical Affairs, Ipsen, Boulogne-Billancourt,France

M. FeuillyHealth Economics and Outcomes Research, Ipsen,Boulogne-Billancourt, France

A. HouchardBiometry, Ipsen, Boulogne-Billancourt, France

D. CellaDepartment of Medical Social Sciences,Northwestern University Feinberg School ofMedicine, Chicago, IL, USA

Adv Ther (2020) 37:1608–1619

https://doi.org/10.1007/s12325-020-01255-8

The attribute ranked most important was ‘con-fidence the syringe will not be clogged’ (24.4%);least important was ‘convenience of syringeformat, including packaging, from preparationto injection’ (34.4%).Conclusions: Nurses preferred the user experi-ence of the LAN new syringe compared with theoctreotide LAR syringe, with a particular pref-erence for attributes related to product deliverywith the LAN new syringe.

Keywords: New syringe; Nurse preference;Simulated injection; Somatostatin analogue

Key Summary Points

Why Carry out This Study?

The lanreotide autogel/depot (LAN) newsyringe was developed in collaborationwith patients, caregivers and healthcareprofessionals to ensure it met their needs,and a validation study has confirmed thatit can be used effectively and safely.

Human factors engineering representsa new sector of syringe designing aswell as the recognised need to focus onimproving the injection experience byengaging with those who use thesyringes during the design process.

To test a new delivery system, it should beassessed in an environment that simulatesa real injection.

The LAN new syringe is now approved foruse in several countries. The aim of thepresent study (PRESTO) was to assess thepreferences of nurses between the LANnew syringe and the current octreotidelong-acting release (LAR) syringe afterperforming simulated injections.

What Was Learned From the Study?

In this study, almost all nurses (97.8%)reported a preference for the LAN newprefilled/ready-to-use syringe comparedwith the current octreotide LAR syringe.

The syringe attribute ranked mostimportant to nurses was ‘confidence thatthe syringe will not be clogged’.

The results of the PRESTO study suggestthat the LAN new syringe may improveuser experience compared with existingproducts when used in clinical practice.

INTRODUCTION

Somatostatin analogues (SSAs) are used to treatsymptoms and slow tumour progression inpatients with neuroendocrine tumours (NETs)and carcinoid syndrome and to reduce hor-mone secretion and reduce pituitary tumourvolume in patients with acromegaly [1–5].NETs, carcinoid syndrome and acromegaly arechronic conditions requiring long-term treat-ment [6], so it is important to optimise patients’treatment experience. One way to improvepatient experience is through refinement of thedrug delivery system.

For long-acting SSAs, nurses identifiedusability, convenience and safety as key factorsin determining healthcare professional experi-ence [7, 8]. In a previous preference study pub-lished in 2012, nurses preferred the lanreotideautogel/depot (LAN) syringe compared withthat of previous octreotide long-acting release(LAR) [7, 8]. Although nurses preferred the LANsyringe overall and for nearly all syringe attri-butes, the sturdiness of the plunger received ahigher rating for the octreotide LAR syringe [7];this is consistent with feedback from patients,caregivers and healthcare professionalsobtained during a series of formative interview-based studies [9].

Based on these previous findings, and tocontinue to improve patient and nurse experi-ence, the LAN new syringe was developed to bemore ergonomic and user-friendly than theprevious delivery system [9]. The key changesmade to this device included larger flanges(finger supports for pushing the plunger down),new plunger supports, a larger, ridged, non-

Adv Ther (2020) 37:1608–1619 1609

transparent needle cap (previously a see-through needle shield) and a new protectivetray [9]. The present study is the first to askexperienced nurses to report their preferencebetween the LAN new syringe and the currentoctreotide LAR syringe.

METHODS

Study Design

The PREference STudy of lanreOtide autogel(PRESTO) was a multinational, multicentre,noninterventional, simulated-use study involv-ing nurses with experience managing patientswith NETs and/or acromegaly by injecting long-acting SSAs. This study was performed at clini-cal or market research centres in countrieswhere the LAN new syringe was approved priorto or during the testing period (if during, testingsessions were initiated after the approval date):Belgium, Germany, Italy, Spain, the UK and theUSA. All centres allowed for the shipment ofstudy drug to these locations and storage inrefrigerators.

Nurses attended a single testing sessionbetween June 2019 and September 2019, duringwhich they injected injection pads (RemedySimulation Group, Perkasie, PA, USA, or 3B Sci-entific, Somerset, UK) with each syringe twice(randomised injection order) before reportingtheir preferences. Data were collected using ananonymous, self-administered, cross-sectional,web-based questionnaire on a tablet device.

Recruitment and Eligibility Criteria

Nurses from organisations and institutions wherepatients with acromegaly and/or NETs were rou-tinely treated were targeted for recruitment.Identified nurses were sent an invitation email,which contained a nurse identification form toassess eligibility and qualifications. Further detailsof the recruitment process are available in thesupplementary materials.

Eligible participants were adultsaged C 18 years, employed as a hospital- orcommunity-based nurse, or nurse from a local

physician’s office or nurses’ network,with C 2 years’ current and/or previous experi-ence administering long-acting SSA injectionsto patients with acromegaly and/or NETs (C 4acromegaly and/or NETs patients per year; orC 1 every 3 months). No specific exclusion cri-teria were defined.

All enrolled nurses signed a questionnaireparticipation consent form to participate intesting sessions and to complete thequestionnaire.

Testing Sessions

Eligible nurses were invited to attend a 60–90-mintesting session (up to seven nurses per session).Sessions were standardised across testing centresand conducted in the local language (English,French, Flemish, German, Italian or Spanish). Atthese sessions, clinical research associates (CRAs)provided nurses with injection-related testingresources, including leaflets with informationabout each syringe and a slide deck that includedastudy overview, and detailed instructions fortesting the syringes and completing the electronicquestionnaire.

Nurses were provided with materials toadminister four simulated injections (two witheach product: LAN 120 mg and octreotide LAR 20or 30 mg) into two injection pads (one per pro-duct). Both syringes were provided by Ipsen,contained real products and were labelled ‘not forhuman use’ on the box in their local language.LAN new syringe packs consisted of a pre-filled,ready-to-use syringe (0.5 ml with an automaticsafety system and a 1.2 9 20 mm needle) in alaminated pouch. Octreotide LAR syringe packscontained: one 6-ml glass vial with a rubberstopper, sealed with an aluminium flip-off seal,containing powder for suspension for injection;one 3 ml pre-filled glass syringe with a front andplunger stopper with 2 ml solvent, co-packaged ina sealed blister tray; one vial adapter; one safetyinjection needle. Before each session, productswere retrieved from the refrigerator at least30 min prior to the testing as per instructions foruse on the label [10, 11].

The order of injections with each productwas randomised using a pre-populated

1610 Adv Ther (2020) 37:1608–1619

randomisation list with block sizes of two toensure counter balance in the ordering of syr-inges throughout each session and the study.CRAs at each session were given a unique sec-tion of the randomisation list to prepopulatethe session log, and nurses were assigned arandomisation number consecutively uponarrival.

After testing each syringe twice, nursescompleted the web-based questionnaire using atablet device. CRAs completed the session andrandomisation number fields for each partici-pant. Once the questionnaire was completed,data were saved on a secure central server.

Objectives and Assessments

To develop the current web-based question-naire, a systematic literature review, detailed inthe supplementary materials, was performed toidentify relevant previous preference studiesthat utilised a questionnaire methodology withadditional input from a patient-reported out-comes expert (DC) and nurses (including DA).The web-based questionnaire, comprised of asingle four-level preference question, and therating and ranking of nine pre-defined attri-butes, is provided in full in the supplementarymaterials.

The primary objective of PRESTO was toassess nurses’ preference for the LAN new syr-inge compared with the octreotide LAR syringeafter performing injections into injection pads.This was assessed by the proportion of nurseswho stated a strong/slight preference for eachsyringe in response to an overall preferenceitem with four response options (slight orstrong preference for the LAN new syringe orthe octreotide LAR syringe).

Secondary objectives were:

1. To describe nurse preferences for the attri-butes of each syringe, evaluated throughrating nine pre-defined attributes using a5-point Likert-type response scale from1 (not at all) to 5 (very much).

2. To describe the importance of syringeattributes. Based on the same nine pre-defined attributes, nurses were then askedto rank the three most important attributes

(in rank order) and one least importantattribute. Nurses were also asked if anyattributes they considered important werenot listed.

3. To describe the clinical characteristics ofnurses (e.g., clinical experience, setting).

4. To describe the sociodemographics ofnurses (e.g., age, gender).

The exploratory objective was to assess howsyringe attributes and factors such as nursecharacteristics and sociodemographics relatedto overall preference.

During nurse sessions, an issue was identi-fied: a number of injections administered usingthe octreotide LAR syringe resulted in clogging,found to be due to the injection pad, which wasconsequently changed during the course of thestudy. Further details on this issue are describedin the supplementary materials.

Statistical Analyses

This study aimed to recruit 90 nurses based on ameaningful difference of approximately 15percentage points and a preference of 57.5% forone syringe and 42.5% for the other syringe.This sample size was based on using a one-sample binomial test with a power of 81% andtwo-sided 5% alpha level. This sample size wasdetermined prior to initiating recruitment.Analyses were carried out on the enrolled anal-ysis set (all nurses), consisting of all participantswho self-reported meeting all eligibility criteria,as well as by injection pad used, defined as thefirst pad analysis set (FPAS) and second padanalysis set (SPAS).

The primary outcome was analysed using aone-sample binomial test for proportions ofnurses preferring the LAN new syringe com-pared with the octreotide LAR syringe. Theimportance of attributes for each syringe aresummarised descriptively through frequency ofresponses, related percentages and the differ-ence in rating between the two syringes usingpaired t tests. Analysis of syringe attributes wasalso categorised by scores of\5 and 5 (i.e.,highest rating, 5 = very much), also known as a‘top-box’ score [12–15]. Rankings for eachattribute are summarised descriptively through

Adv Ther (2020) 37:1608–1619 1611

frequencies and percentages indicating the first,second and third most important and the leastimportant.

Descriptive analyses were conducted forclinical characteristics and sociodemographicsof nurses, including frequencies and percent-ages for categorical variables.

Exploratory analyses were performed usingunivariate logistic regression models to identifyparameters associated with overall preferenceusing a significance level of P\0.20, presentedas the odds ratio (OR; 95% confidence interval[CI]). Collinearity of these selected variables wasexamined through correlations, ANOVAs, chi-square or Fisher tests, as appropriate. Variablesin the univariable logistic regression model witha significance level of P\ 0.2 were consideredfor inclusion in a multivariable model.

All data were forced responses; thus, therewere no missing data in variables captured. Allanalyses were performed using SAS� v9.3 orlater (SAS Institute, Cary, NC, USA).

Ethics

As this study was not a clinical trial and nopatients were involved, institutional review boardapprovals were not required. This study followedthe recommendations from the InternationalSociety for Pharmacoepidemiology, Good Phar-macoepidemiology Practice Guidelines, April2007. The confidential nature of personal infor-mation was maintained and participating nursesprovided authorisation for the use and disclosureof personal information (e.g. age, gender, clinicalexperience) in the study.

RESULTS

Nurse Characteristics

In total, 93 nurses participated in the testingsessions and completed the web-based ques-tionnaire, of which 90 questionnaires werevalidated; three nurses were not includedbecause of a saving error that meant that theirresponses were not retrievable. A flow diagram

of study recruitment is shown in Fig. 1. In total,24 testing sessions took place; 10 were con-ducted using PAD1 (n = 45) and 14 using PAD2(n = 45). The mean number of nurses per ses-sion was 3.8 (95% CI 3.0, 4.5) overall, and 4.5(95% CI 3.4, 5.6) and 3.2 (95% CI 2.2, 4.2) inthe FPAS and SPAS groups, respectively.

Overall, the mean (SD) age of nurses was 44.2(10.6) years and 88.3% were female. The largestproportion of nurses was from Italy (48.9%),followed by the USA (27.8%), UK (8.9%), Ger-many (7.8%), Belgium and Spain (3.3% each).Further details of sociodemographic character-istics and clinical setting, including clinicaldepartment and data for the FPAS and SPAS, areprovided in Table S1. The clinical experience ofnurses is shown in Fig. 2, with further detailsprovided in Table S2. The median length oftime nurses had experience injecting LAN and

Fig. 1 Recruitment of study nurses. FPAS first padanalysis set, NIF nurse identification form, SPAS secondpad analysis set

1612 Adv Ther (2020) 37:1608–1619

octreotide LAR was 4.0 (95% CI 3.0, 6.0) yearsand 7.5 (95% CI 5.0, 10.0) years, respectively.

Overall Preference

Overall, 97.8% (95% CI 92.2, 99.7) of nursesexpressed a preference for the LAN new syringe,while 2.2% (95% CI 0.3, 7.8) preferred theoctreotide LAR syringe (P\ 0.0001). The pro-portion of nurses who reported a ‘slight’ or‘strong’ preference for each syringe is presentedin Fig. 3. The overall reported preferences werethe same between the FPAS and SPAS.

Performance Ratings for SyringeAttributes

Syringe attribute performance ratings for theLAN new syringe and the octreotide LAR syringeare shown in Fig. 4 and Table S3. Nonotable differences were observed between theFPAS and SPAS; thus, the results described beloware for the overall population.

Attribute performance ratings were consis-tently higher for the LAN new syringe com-pared with the octreotide LAR syringe, with thegreatest differences in ratings for ‘fast adminis-tration from preparation to injection’ and‘confidence that the syringe will not be clogged’(mean difference: 2.6 [95% CI 2.4, 2.9] and 2.3[95% CI 2.0, 2.6], respectively; P\ 0.0001).

The proportion of nurses who awarded thehighest rating (‘very much’) in response to theperformance statements is presented in Fig. S1.The majority of nurses gave maximum perfor-mance ratings for the LAN new syringe on allattributes, ranging from 58.9% (95% CI 48.0,69.2) for the attribute ‘comfortable to holdduring use from preparation to injection’ to81.1% (95% CI 71.5, 88.6) for the attribute‘confidence that there is no loss of productduring preparation or delivery’. Few nurses gavemaximum performance ratings for the octreo-tide LAR syringe for any attribute.

The attribute most frequently ranked as mostimportant was ‘confidence that the syringe willnot be clogged’ (24.4% [95% CI 16.0, 34.6])

Fig. 2 Clinical experience of nurses, length of timeinjecting patients using LAN or octreotide LAR. LANlanreotide, LAR long-acting release. Further details of theclinical experience of nurses are presented in Table S2

Fig. 3 Reported preferences for somatostatin analogue syringe. Error bars represent the 95% CIs. CI confidence interval,FPAS first pad analysis set, LAN lanreotide autogel/depot, LAR long-acting release, SPAS second pad analysis set

Adv Ther (2020) 37:1608–1619 1613

followed by ‘confidence that there is no loss ofproduct during preparation or delivery’ (21.1%[95% CI 13.2, 31.0]), and the least importantwas ‘convenience of syringe format, includingpackaging, from preparation to injection’(34.4% [95% CI 24.7, 45.2]) (Fig. 5 andTable S4).

In response to a free-text question, 10.0% ofnurses (FPAS: 11.1%; SPAS: 8.9%) consideredthere to be an important attribute missing fromthe pre-defined list. The identified missingattributes were related to: patient comfort andsafety during and/or after injection, raised byfour nurses; biomechanical feedback of theneedle/injection during and/or after injection,raised by three nurses; the possibility of self-administration, raised by two nurses; and thedilution/solubility of octreotide LAR, raised byone nurse.

Factors Associated with Overall Preference

The following variables were associated(P\0.20) with overall preference for the LANnew syringe in a univariate fashion: number ofyears’ experience injecting patients using theoctreotide LAR syringe (OR [95% CI]: 2.2 [0.8,5.9]), number of patients with NETs and/oracromegaly treated in the last 12 months usingoctreotide LAR (OR [95% CI]: 1.5 [0.8, 2.6]) andthe octreotide LAR syringe attribute perfor-mance ratings for ‘fast administration frompreparation to injection’ (OR [95% CI]: 0.4 [0.1,1.3]) and ‘convenience of syringe formatincluding packaging from preparation to injec-tion’ (OR [95% CI]: 0.2 [0.0, 1.4]). Nocollinearity was identified, and all pre-selectedvariables were included into the multivariatemodel. In the multivariate model, no variables

Fig. 4 Evaluation of preference for somatostatin analoguesyringe based on the performance of each attribute.Responses in answer to the following survey question:Considering the testing performed earlier today, we wouldnow like you to evaluate the performance from 1 to 5 ofLAN new syringe and octreotide LAR syringes on each

attribute. Please rate each syringe where: 1 = not at all,2 = a little bit, 3 = somewhat, 4 = quite a bit, 5 = verymuch. Please see Table S3 for SD and 95% confidenceintervals and data for the first and second pad analysis sets.LAR long-acting release

1614 Adv Ther (2020) 37:1608–1619

were associated with overall preference for theLAN new syringe at the 0.05 level.

DISCUSSION

In the present study, nurses reported a consid-erable preference for the LAN new syringecompared with that for the current octreotideLAR syringe; furthermore, when nurses wereasked to rate the performance of particular syr-inge attributes, ratings for each attribute wereconsistently higher for the LAN new syringe.

Overall, 97.8% of nurses reported a prefer-ence for the LAN new syringe over the octreo-tide LAR syringe, with the majority of nursesreporting a ‘strong’ preference. Results weresimilar for both the FPAS and SPAS for the pri-mary endpoint, suggesting that the initial issuewith the octreotide LAR syringe clogging usingPAD1 did not impact upon the overall findings.Exploratory analyses also showed that thesociodemographics or clinical experience ofnurses did not have an impact on overall pref-erence. In a previous study, the overall

preference score by nurse assessment was 63percentage-points higher for the LAN previoussyringe compared with the previous octreotideLAR syringe [7] and, in another study, 81% ofpatients who switched from octreotide LAR toLAN preferred to continue treatment with LAN[16]. Given the almost universal preference forthe LAN new syringe in the PRESTO study, thissuggests that the advancements made for theLAN syringe (larger flanges; a larger, more rigidnon-transparent needle cap; new plunger sup-ports; new protective tray) [9] following feed-back from nurses [7] and from patients,caregivers and nurses in formative human fac-tors studies [9] resulted in improved user expe-rience with this new device.

Fast administration and confidence that thesyringe would not be clogged were the attri-butes with the greatest differences in perfor-mance ratings between the two syringes, infavour of the LAN new syringe, and whenranked in order of importance, confidence thatthe syringe would not be clogged was the mostimportant attribute. During the study, the issueof clogging with the octreotide LAR syringe was

Fig. 5 Ranked importance of syringe attributes according to nurses. Data are presented for all nurses. Error bars represent95% confidence intervals. Please see Table S4 for full details and data for the first and second pad analysis sets

Adv Ther (2020) 37:1608–1619 1615

found to be caused by the injection padsused; however, no notable difference wasobserved between the FPAS and SPAS for theperformance rating of syringes for this attribute(mean difference in ratings between syringes 2.5[95% CI 2.0, 2.9] and 2.1 [95% CI 1.6, 2.5],respectively) or the percentage of nurses whoranked this as the most important attribute(22.2% [95% CI 11.2, 37.1] and 26.7% [95% CI14.6, 41.9], respectively). This risk of cloggingwith the previous and current octreotide LARsyringe is not uncommon and has been repor-ted in previous studies, including reporting ofnurses and clinical staff in response to ques-tionnaires [7, 17], as well as in studies thatreport the experience of patients [18, 19]. It istherefore possible that previous experiencemay have influenced nurses’ responses to thisparticular attribute.

The second most important attribute iden-tified in the present study was confidence thatthere would be no loss of product duringpreparation or delivery, with no differenceobserved between the percentage of nurseswho ranked this attribute as the most impor-tant between the FPAS and SPAS (22.2%[95% CI 11.2, 37.1] and 20.0% [95% CI 9.6,34.6]). Nurses have previously identified ‘con-fidence that a full dose has been delivered’ asthe most important attribute for SSA syringes[7], and it is a concern among patients withchronic diseases who administer self-injectionsthat product can be lost if injections are tooshallow [20]. However, in the present study,81% of nurses gave the highest rating for thestatement regarding confidence of no productwas lost with the LAN new syringe comparedwith 10% for the octreotide LAR syringe. Fur-thermore, needle retraction is an establishedbenefit of the LAN previous syringe, con-tributing to the reported low risk of needle-stick injuries compared with the previousoctreotide LAR syringe [7]. This feature wascarried forward to the LAN new syringe and, asshown in the present study, nurses’ ‘confi-dence that there is low risk of needle stickinjuries’ achieved a mean score of 4.4 (95% CI4.2, 4.6) compared with 3.2 (95% CI 2.9, 3.4)for the octreotide LAR syringe.

Strengths and Limitations

The most prominent limitation of this studywas the need for a change in injection pad after10 injection sessions due to clogging issues. Thisresulted in outcomes being presented for theFPAS and SPAS. It should be noted that injec-tions performed in the present study were sim-ulated and therefore differ from real-lifeinjections in patients and that, since the LANnew syringe was recently launched, there were alimited number of countries where this studycould be performed. There were some imbal-ances noted in sociodemographics and clinicalsettings of nurses. In the overall population49% of nurses were recruited from Italy, fol-lowed by 28% from the USA, and the majorityof nurses were recruited from an oncology(42%) or endocrinology (43%) department/unit/ward. To avoid the global risk of notcompleting the study within the plannedtimelines, IQVIA network nurses participated inthe study. Consequently, this potentiallyintroduced biased reporting of preferences dueto potential conflicts of interest for these nurses.Potential selection bias may also be consideredbased on nurses’ voluntary participation in thestudy; although perhaps not unusual for thistype of study, almost half of nurses invited byemail were non-responders and it was consid-ered that only nurses who were willing and feltthey met the required criteria may haveresponded. Altogether, the risk of selection biaswas considered minimal, as the nurses did notgain financially from success or failure of thestudy and all data was anonymised, so theywould be likely to state their true preferences.

The strengths of the PRESTO study includethe robustness of the study design based on thepre-specified sample size calculation and therandomisation of injection order at the nurselevel, which reduced the potential for bias. Thisstudy benefited from the recruitment of expe-rienced nurses who perform injections in bothNETs and acromegaly patients and who wererecruited internationally to avoid a centre orcountry effect. The questionnaire used in thisstudy was carefully designed through a system-atic literature search to identify relevant priorpublications and developed with input from the

1616 Adv Ther (2020) 37:1608–1619

end users and a patient-reported outcomesexpert. Compared with the previous nursepreference study [7], PRESTO used a choice-based question to assess the nurses’ statedpreference between syringes, which is a strengthof this study, as it is more consistent with real-life decision-making. Improving patients’experience with injectable devices throughoptimising delivery and gaining user insightson their device experiences and preferences isnot unique to treatment with SSAs, but is also akey topic of research in therapy areas such asdiabetes [21–23].

CONCLUSION

The PRESTO study showed that nurses witheither past or current experience injecting long-acting SSAs in patients with NETs and/or acro-megaly in the EU and the USA preferred the userexperience of the LAN new syringe over that ofthe current octreotide LAR syringe, whenassessed through simulated injection. Theattributes with the greatest difference in scoresbetween syringes were fast administration andconfidence the syringe will not be clogged, infavour of the LAN new syringe. These resultssuggest that the LAN new syringe has overcomethe shortcomings identified with the previousLAN syringe and may therefore improve userexperience compared with previous and/orcurrent products, when used in clinical practice.

ACKNOWLEDGEMENTS

The authors thank all nurses who participatedin the study. The authors would also like tothank the contract research organisation,IQVIA, for its contribution to study recruitmentand conduct of the study sessions; in particular,Mr Paul Williams (Lead Statistician, Real WorldSolutions, IQVIA), who led the design and sci-entific aspects, analysis, and interpretation andreporting of results, and Dr Laurie Batchelder(Lead Medical Writer, Real World Solutions,IQVIA), who substantially contributed to thedesign of the survey and protocol, statisticalanalysis plan and discussion of the report.

Funding. Sponsorship for this study and thejournal’s Open Access and Rapid Service feewere funded by Ipsen.

Medical Writing and Editorial Assis-tance. The authors thank Jacqueline Harte andHelen Marshall of Watermeadow Medical, anAshfield company, for providing medical writ-ing and editorial support, which was sponsoredby Ipsen in accordance with Good PublicationPractice guidelines.

Authorship. All named authors meet theInternational Committee of Medical JournalEditors (ICMJE) criteria for authorship for thisarticle, take responsibility for the integrity ofthe work as a whole, and have given theirapproval for this version to be published. Allauthors contributed to the study conception/design, or acquisition, analysis, and/or inter-pretation of data. All authors were involved indrafting and/or critical revision of the manu-script for intellectual content and provided finalapproval for publication. Ipsen was involved inthe study design, conduct, and analysis of thisstudy, and provided funding for the medicalwriting support to develop this publication.Study recruitment and conduct of the studysessions was managed by the contract researchorganisation, IQVIA.

Prior Presentation. An abstract has beensubmitted for presentation at ENETS, Barcelona,Spain, 11–13th March 2020.

Disclosures. DA received: consultancy feesfrom Pfizer and Novo Nordisk; and has servedon an advisory board for Ipsen, Crinetics andNovo Nordisk. DC received: consultancy feesfrom Ipsen and Novartis; and grant supportfrom Ipsen and Novartis. XMTT, MF and AH areemployees of Ipsen.

Compliance with Ethics Guidelines. As thisstudy was not a clinical trial and no patientswere involved, institutional review boardapprovals were not required. This study fol-lowed the recommendations from the Interna-tional Society for Pharmacoepidemiology, GoodPharmacoepidemiology Practice Guidelines,

Adv Ther (2020) 37:1608–1619 1617

April 2007. The confidential nature of personalinformation was maintained and participatingnurses provided authorisation for the use anddisclosure of personal information in the study.

Data Availability. Where participant datacan be anonymised, Ipsen will share all indi-vidual participant data that underlie the resultsreported in this article with qualified research-ers who provide a valid research question. Studydocuments, such as the study protocol andclinical study report, are not always available.Proposals should be submitted to DataShar-ing@Ipsen.com and will be assessed by a scien-tific review board. Data are available beginning6 months and ending 5 years after publication;after this time, only raw data may be available.

Open Access. This article is licensed under aCreative Commons Attribution-NonCommer-cial 4.0 International License, which permitsany non-commercial use, sharing, adaptation,distribution and reproduction in any mediumor format, as long as you give appropriate creditto the original author(s) and the source, providea link to the Creative Commons licence, andindicate if changes were made. The images orother third party material in this article areincluded in the article’s Creative Commonslicence, unless indicated otherwise in a creditline to the material. If material is not includedin the article’s Creative Commons licence andyour intended use is not permitted by statutoryregulation or exceeds the permitted use, youwill need to obtain permission directly from thecopyright holder. To view a copy of this licence,visit http://creativecommons.org/licenses/by-nc/4.0/.

REFERENCES

1. Caplin ME, Pavel M, Cwikla JB, et al. Lanreotide inmetastatic enteropancreatic neuroendocrinetumors. N Engl J Med. 2014;371:224–33.

2. Rinke A, Muller HH, Schade-Brittinger C, et al.Placebo-controlled, double-blind, prospective, ran-domized study on the effect of octreotide LAR inthe control of tumor growth in patients withmetastatic neuroendocrine midgut tumors: a report

from the PROMID Study Group. J Clin Oncol.2009;27:4656–63.

3. Strosberg J, Kvols L. Antiproliferative effect ofsomatostatin analogs in gastroenteropancreaticneuroendocrine tumors. World J Gastroenterol.2010;16:2963–70.

4. Caron PJ, Bevan JS, Petersenn S, et al. Tumorshrinkage with lanreotide Autogel 120 mg as pri-mary therapy in acromegaly: results of a prospectivemulticenter clinical trial. J Clin Endocrinol Metab.2014;99:1282–90.

5. Khan MS, El-Khouly F, Davies P, Toumpanakis C,Caplin ME. Long-term results of treatment ofmalignant carcinoid syndrome with prolongedrelease Lanreotide (Somatuline Autogel). AlimentPharmacol Ther. 2011;34:235–42.

6. Oberg K, Lamberts SW. Somatostatin analogues inacromegaly and gastroenteropancreatic neuroen-docrine tumours: past, present and future. EndocrRelat Cancer. 2016;23:R551–66.

7. Adelman DT, Burgess A, Davies PR. Evaluation oflong-acting somatostatin analog injection devicesby nurses: a quantitative study. Med Dev (Auckl).2012;5:103–9.

8. Ryan P, Phan AT, Adelman DT, Iwasaki M. Neu-roendocrine tumors and lanreotide depot: clinicalconsiderations and nurse and patient preferences.Clin J Oncol Nurs. 2016;20:E139–46.

9. Adelman DT, Van Genechten D, Megret CM,Truong Thanh XMT, Hand P, Martin WA. Co-cre-ation of a lanreotide autogel/depot syringe for thetreatment of acromegaly and neuroendocrinetumours through collaborative human factor stud-ies. Adv Ther. 2019;36:3409–23.

10. Novartis. Sandostatin� LAR summary of productcharacteristics. 2018. https://www.medicines.org.uk/emc/product/1038/smpc. Accessed 22 Nov2019.

11. Ipsen Ltd. Somatuline� Autogel� summary of pro-duct characteristics. 2019. https://www.medicines.org.uk/emc/product/8257/smpc. Accessed 22 Nov2019.

12. Chen JG, Zou B, Shuster J. Relationship betweenpatient satisfaction and physician characteristics.J Patient Exp. 2017;4:177–84.

13. Godden E, Paseka A, Gnida J, Inguanzo J. Theimpact of response rate on Hospital ConsumerAssessment of Healthcare Providers and System(HCAHPS) dimension scores. Patient Exp J. 2019;6:105–14.

1618 Adv Ther (2020) 37:1608–1619

14. Indovina K, Keniston A, Reid M, et al. Real-timepatient experience surveys of hospitalized medicalpatients. J Hosp Med. 2016;11:251–6.

15. Reichheld F. The one number you need to grow:Harvard business review; 2003. https://hbr.org/2003/12/the-one-number-you-need-to-grow#. Accessed 9Jan 2019.

16. Salvatori R, Nachtigall LB, Cook DM, et al. Effec-tiveness of self- or partner-administration of anextended-release aqueous-gel formulation of lan-reotide in lanreotide-naive patients with acrome-galy. Pituitary. 2010;13:115–22.

17. Ryan P, McBride A, Ray D, et al. Lanreotide vsoctreotide LAR for patients with advanced gas-troenteropancreatic neuroendocrine tumors: anobservational time and motion analysis. J OncolPharm Pract. 2019;25:1425–33.

18. Strom T, Kozlovacki G, Myrenfors P, Almquist M.Patient and nurse experience of using somatostatinanalogues to treat gastroeneteropancreatic neu-roendocrine tumors: results of the SomatostatinTreatment Experience Trial (STREET). Patient PreferAdher. 2019;13:1799–807.

19. Alexopoulou O, Abrams P, Verhelst J, et al. Efficacyand tolerability of lanreotide Autogel therapy inacromegalic patients previously treated withoctreotide LAR. Eur J Endocrinol. 2004;151:317–24.

20. Schiff M, Saunderson S, Mountian I, Hartley P.Chronic disease and self-injection: ethnographicinvestigations into the patient experience duringtreatment. Rheumatol Ther. 2017;4:445–63.

21. Matza LS, Stewart KD, Paczkowski R, Coyne KS,Currie B, Boye KSJJoP-RO. Psychometric evaluationof the Diabetes Injection Device Experience Ques-tionnaire (DID-EQ) and Diabetes Injection DevicePreference Questionnaire (DID-PQ). 2018;2:44.

22. Qin L, Chen S, Flood E, et al. Glucagon-like peptide-1 receptor agonist treatment attributes important toinjection-experienced patients with type 2 diabetesmellitus: a preference study in Germany and theUnited Kingdom. Diabetes Ther. 2017;8:335–53.

23. Pandya N, Losben N, Moore J. Optimizing insulindelivery for patients with diabetes. Geriatr Nurs.2018;39:138–42.

Adv Ther (2020) 37:1608–1619 1619