Evidence mapPaperPMID 34541982Full record

Trial reportDrug delivery2021

Advances in subcutaneous injections: PRECISE II: a study of safety and subject preference for an innovative needle-free injection system.

E Lynne Kelley, Richard H Smith, Gillian Corcoran, Sandra Nygren, Mary V Jacoski, Andrea Fernandes

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug delivery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
field-weighted citation impact
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. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
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  8. Article
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

6 authors.

E Lynne KelleyPortal Instruments, Cambridge, MA, USA.
Richard H SmithPortal Instruments, Cambridge, MA, USA.
Gillian CorcoranPortal Instruments, Cambridge, MA, USA.
Sandra NygrenPortal Instruments, Cambridge, MA, USA.
Mary V JacoskiPortal Instruments, Cambridge, MA, USA.
Andrea FernandesPortal Instruments, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Needle-free injection is a desirable goal for many reasons, including reducing pain, anxiety, and eliminating safety risks associated with needle-stick injuries. However, development of a safe, reliable needle-free device optimized for at-home use has been met with many challenges. Portal Instruments Inc. has been developing needle-free medication delivery using a well-designed hand-held device, PRIME, that is safe, intuitive to use, and utilizes advanced electronic control of a focused, high velocity, pressurized liquid injection stream. The PRECISE II human study demonstrated that the PRIME needle-free injection system was safe, well tolerated, and strongly preferred by participants for self-injections over a standard needle and syringe. In addition, the study was able to be completed early for superiority following the success of the pre-defined interim analysis.

Indexed as

Patient PreferenceAdultCross-Over StudiesFemaleHumansInjections, SubcutaneousMaleMiddle AgedNeedlesProspective StudiesNeedle-free injectorpainpreferenceself-injectionsubcutaneous injection

Identifiers

PMID34541982
PMCPMC8462839

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.