Evidence map›Paper›PMID 33561056›Full record

ArticleInternational journal of environmental research and public health2020

Study Protocol for Two-Steps Parallel Randomized Controlled Trial: Pre-Clinical Usability Tests for a New Double-Chamber Syringe.

Pedro Parreira, Liliana B Sousa, Inês A Marques, Paulo Santos-Costa, Sara Cortez, Filipa Carneiro, Arménio Cruz, Anabela Salgueiro-Oliveira

Abstract readClinical Trial Protocol
In one paragraph

Article in International journal of environmental research and public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

8 authors.

Pedro ParreiraThe Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.ORCID 0000-0002-3880-6590
Liliana B SousaThe Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.ORCID 0000-0002-8914-6975
Inês A MarquesThe Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.
Paulo Santos-CostaThe Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.ORCID 0000-0003-0761-6548
Sara CortezMuroplás-Plastic Engineering Industry, 4745-334 Muro, Portugal.ORCID 0000-0002-2794-084X
Filipa CarneiroPIEP-Innovation in Polymer Engineering, Guimarães, 4800-058 Braga, Portugal.ORCID 0000-0002-4439-4166
Arménio CruzThe Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.ORCID 0000-0003-3254-3176
Anabela Salgueiro-OliveiraThe Health Sciences Research Unit, Nursing, Nursing School of Coimbra, 3004-011 Coimbra, Portugal.ORCID 0000-0002-8231-8279

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A new double-chamber syringe (DUO Syringe) was developed for intravenous drug administration and catheter flushing. This study presents a protocol for pre-clinical usability tests to validate the golden prototype of this new device, performed in a high-fidelity simulation lab by nurses. A two-steps parallel randomized controlled trial with two arms was designed (with standard syringes currently used in clinical practice and with the DUO Syringe). After randomization, eligible and consented participants will be requested to perform, individually, intravenous drug administration and flushing, following the arm that has been allocated. The procedure will be video-recorded for posterior analyses. After the completion of the tasks, nurses will be asked to answer a demographic survey, as well as an interview about their qualitative assessment of the device. A final focus group with all participants will also be conducted. Primary outcomes will concern the DUO Syringe's effectiveness, efficiency, and safety, while secondary outcomes will focus on nurses' satisfaction and intention of use. The pre-clinical protocol was defined according to the legal requirements and ISO norms and was reviewed and approved by the Ethics Committee of the Health Sciences Research Unit: Nursing of the Nursing School of Coimbra.

Indexed as

Randomized Controlled Trials as TopicAdministration, IntravenousEquipment DesignHumansPharmaceutical PreparationsSyringesTreatment OutcomePharmaceutical Preparationsmedical devicesnursing researchusability tests

Identifiers

PMID33561056
PMCPMC7696070

What OpenQuestion holds

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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.