Evidence map›Paper›PMID 30836359›Full record

Observational studyHormone research in paediatrics2018

Needle-Free and Needle-Based Growth Hormone Therapy in Children: A Pooled Analysis of Three Long-Term Observational Studies.

Tilman R Rohrer, Sabine Ceplis-Kastner, Norbert Jorch, Hermann L Müller, Roland Pfäffle, Thomas Reinehr, Annette Richter-Unruh, Claudia Weißenbacher, Paul-Martin Holterhus, Dr Sabine Clips-Kastner Ferring Arzneimittel GmbH

Open access · hybridAbstract readComparative StudyObservational Study
In one paragraph

Observational study in Hormone research in paediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 28% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 1 country.

Tilman R RohrerDepartment of Paediatrics, Saarland University Medical Centre, Homburg/Saar, Germany.
Sabine Ceplis-KastnerMedical Department, Ferring Arzneimittel GmbH, Kiel, Germany.
Norbert JorchProtestant Hospital of the Bethel Foundation, Children's Hospital, Bielefeld, Germany.
Hermann L MüllerDepartment of Paediatrics and Paediatric Haematology/Oncology, University Children's Hospital, Klinikum Oldenburg AöR, Oldenburg, Germany.
Roland PfäffleDepartment of Paediatric Endocrinology, Children's Hospital, Leipzig, Germany.
Thomas ReinehrDepartment of Paediatric Endocrinology, Diabetes, and Nutrition Medicine, Vestische Kinder- und Jugendklinik, University of Witten/Herdecke, Datteln, Germany.
Annette Richter-UnruhDepartment of Paediatric Endocrinology and Diabetology, University Children's Hospital, Ruhr University Bochum, Bochum, Germany.
Claudia WeißenbacherDepartment of Endocrinology, Dr. von Haunersches Children's Hospital, LMU Munich, Munich, Germany.
Paul-Martin HolterhusDivision of Paediatric Endocrinology and Diabetes, Christian-Albrechts University of Kiel (CAU) and University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany, PaulMartin.Holterhus@uksh.de.
Dr Sabine Clips-Kastner Ferring Arzneimittel GmbH
Christian-Albrechts-Universität zu Kiel · DEEvangelisches Krankenhaus Bielefeld · DEFerring Pharmaceuticals (Germany) · DEKlinikum Oldenburg · DELudwig-Maximilians-Universität München · DESaarland University · DEUniversity Hospital Leipzig · DEUniversity Hospitals of the Ruhr-University of Bochum · DEWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment with growth hormone (GH) is standard clinical practice in children with GH deficiency (GHD) or Turner syndrome (TS). Hitherto, no long-term data on auxological outcome and safety of Zomacton® have been published. Data comparing needle-free administration (NF) and needle injection (NI) of GH are very sparse.

aimsTo analyse longitudinal auxological outcome and safety data of GH treatment-naïve patients diagnosed with GHD or TS and to compare NF and NI in a real-life setting.

methodsPooled auxological data and safety information from three consecutive prospective observational Zomacton® studies covering 22 years of treatment were analysed and NF was compared to NI.

resultsThe safety cohort comprised 1,595 patients who received at least one GH dose. The auxological outcome cohort comprised 856 treatment-naïve patients with follow-up data ≥12 months. Height-SDS and height velocity improved significantly during the first 3 years of treatment. Documented choice of device was available for 658 patients (NF 69.1%, NI 30.9%). NF administration was non-inferior to NI. No previously unknown safety signals occurred.

conclusionReal-life data show that treatment with Zomacton® improves auxological outcome parameters without new safety concerns. NF administration of GH represents a useful alternative to NI in children with growth disorders.

Indexed as

Dwarfism, PituitaryGrowth DisordersHuman Growth HormoneTurner SyndromeAdolescentChildChild, PreschoolFemaleHumansInfantMaleNeedlesProspective StudiesHuman Growth HormoneAuxological outcomeGrowth hormone deficiencyJet deliverySomatropinTurner syndrome

Identifiers

PMID30836359
PMCPMC6561679
OpenAlexW2918222567

What OpenQuestion holds

Textmetadata
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.