Evidence map›Paper›PMID 31612358›Full record

ArticleAdvances in therapy2019

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

Daphne T Adelman, Dirk Van Genechten, Clémentine M Megret, Xuan-Mai T Truong Thanh, Philippa Hand, Wendy A Martin

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  6. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Daphne T AdelmanFeinberg School of Medicine, Northwestern University, Chicago, IL, USA. d-adelman@northwestern.edu.ORCID 0000-0002-9021-076X
Dirk Van GenechtenInternational Neuroendocrine Cancer Alliance (INCA), Boston, USA.
Clémentine M MegretIpsen PharmSciences, Dreux, France.
Xuan-Mai T Truong ThanhIpsen Pharma, Boulogne-Billancourt, France.
Philippa HandLondon North West University Healthcare NHS Trust, London, UK.
Wendy A MartinKing's College Hospital, London, UK.
Ipsen (France) · FRKing's College Hospital · GBLondon North West Healthcare NHS Trust · GBNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 summary available for this article.

Indexed as

SyringesAcromegalyAdolescentAdultAttitude of Health PersonnelDelayed-Action PreparationsFemaleHumansInjections, SubcutaneousMaleMiddle AgedNeuroendocrine TumorsPatient ParticipationPatient PreferencePeptides, CyclicSomatostatinDelayed-Action PreparationslanreotidePeptides, CyclicSomatostatinAcromegalyAutogelCaregiversDepotLanreotideNeuroendocrine tumoursNursesPatientsSyringe

Identifiers

PMID31612358
PMCPMC6860467
OpenAlexW2980973318

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.