Keywords
intravenous therapy and medicine, review protocol, evidence synthesis, patient safety, practice standards
intravenous therapy and medicine, review protocol, evidence synthesis, patient safety, practice standards
The latest revision of this protocol now incorporates feedback from both peer reviewers. A detailed breakdown of these revisions can be found in the responses to reviewers.
See the authors' detailed response to the review by Zane Robinson Wolf
See the authors' detailed response to the review by Ariane Ferreira Machado Avelar
While the concept and practice of intravenous therapy is centuries old, with the first documented blood transfusion taking place in 1492, the key advancements that have made it a ubiquitous part of healthcare today largely occurred in the last two centuries1. The cholera epidemic in the early 19th century led Dr William Brooke O'Shaughnessy to state “I would not hesitate to inject some ounces of warm water in the veins. I would also, without apprehension, dissolve in that water the mild innocuous salts which nature herself is accustomed to combine with the human blood”2, a theory later tested by Dr Thomas Latta to great success3. Since then healthcare has witnessed a proliferation of new medicines requiring administration via the circulatory system.
Medication safety has been identified internationally by the World Health Organisation as a key area for improvement in all healthcare settings4. In Ireland, a number of medication-related errors appear in the top ten medical incidents reported to the State Claims Agency5 (for example, incorrect dosages, missed medications, medications being incorrect/not reconciled for changes in care). Such medication incidents were reported from multiple services nationally6. Intravenous therapy and medicines (IVTM) safety can impact greatly on patient care. High profile medication errors have directly led to guidance being developed, as well as landmark legal rulings, both resulting in widespread changes to practice7.
With up to 90% of admitted patients now receiving IVTM at some point during their stay in hospital, relevant guidelines are more necessary than ever8. Additionally, while administration of IVTM was initially considered a role for the doctor alone, rapid developments in the field and the changing roles of healthcare professionals (HCPs) means that the majority of clinical staff will be responsible for the management, preparation, and administration of IVTM at some point. This highlights the various number of healthcare professionals involved in IVTM.
In 2018, the Irish Health Information and Quality Authority (HIQA) published its recommendations on the first phase of the Medication Safety Monitoring Programme. It recommends that hospitals provide clinical staff with easily accessible information such as policies, procedures, guidelines and/or protocols to guide the safe use of medicines at the point of prescribing, preparation and administration9.
A guideline is defined as “a principle of criterion that guides or directs action”10. The Irish Health Service Executive framework for developing guidelines emphasises using clear evidence from the existing literature, rather than expert opinion alone10. In systematically reviewing available literature, we can provide better knowledge and evidence for robust guideline for HCPs.
The aim of this review is to synthesise the evidence for a specific question: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?
This evidence synthesis will then feed into the development of new guidelines for the Irish Health Service Executive (HSE) and be disseminated to the wider research and clinical community. Our report will be guided by the PRISMA statement checklist (preferred reporting items for systematic review and meta-analysis) and the synthesis without meta-analysis (SWiM) extension11,12.
Our primary research question, devised by the HSE to inform their guideline development, is “In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?”. The working group developing this national guideline have further identified the following areas as specific topics of interest:
Literature relating to independent double checking of IVTM
Literature relating to the practices required to ensure complete administration of IVTM
Literature relating to use of infusion pumps for the delivery of IVTM
Literature relating to the standards required for labelling IVTM
Literature relating to the education preparation and competency requirements for healthcare professionals administering IVTM
Literature relating to the involvement of the following undergraduate students in the process of preparation and administration of IVTM: nurses, midwives, doctors, paramedics and radiographers.
To ensure that all relevant national and international peer reviewed evidence and policy literature is considered, this review will include randomised controlled trials (RCTs), systematic reviews, meta-analyses, cohort studies, observational studies, national/international guidelines, and expert consensus opinion made available from 2009 to current (See Table 1 for inclusion and exclusion criteria).
Literature must involve the preparation and/or administration of IV medicines via peripheral or central venous access devices.
Studies focusing on needlefree devices or the introduction, care, or maintenance of access devices will be excluded, as will studies examining the administration of blood, blood products, or parenteral nutrition. Studies focusing on consent or infection prevention will be also be excluded, owing to the robust guidelines already integrated into practice (e.g. Epic3 guidelines13 and the Aseptic Non-Touch Technique (ANTT) framework14). Work published before 2009 will be excluded, to ensure the synthesis reflects current best practices.
All patients receiving IV medicines (adults, children and neonates) in primary or secondary care settings (i.e. pre-hospital, acute hospital and community settings).
We will consider for inclusion any publication that details the preparation of IVTM for administration via peripheral or central venous access devices. This will include slow bolus IVTM injections, intermittent and continuous IV infusions. This review will include studies focusing on medical professionals, nurses, midwives, paramedics and radiographers, working within pre-hospital, acute hospital and community settings.
This review will gather safety and effectiveness outcome data. As these two terms underpin best clinical practice, we propose a broad definition of the following:
We will search the following databases for material published after 2009: Cochrane Library, PubMed, CINAHL, and Web of Science. Additionally, we will search OpenGrey and OAlster for grey literature. Searches are available in Extended data15. Searches will be designed by an appropriately experienced search methodologist team member (JDI).
Titles and abstracts will be imported into the systematic review software Covidence16. Two authors will screen the title and abstracts of the citations against the pre-specified eligibility criteria. Any discrepancies will be resolved by a content-expert author (PC) if consensus cannot be reached. The same process will be followed for full-text screening. We will record a rationale for exclusion for any papers deemed ineligible at full text. Both title and abstract and full-text screening processes will be piloted to ensure consistency across authors.
Data will be extracted from included studies by two reviewers (PC, LOC) independently using the data extraction tool within Covidence. Any discrepancies between reviewer’s extractions will be highlighted by Covidence, and consensus will be reached through discussion where necessary. The data extraction form will be piloted by two authors (PC, LOC).
Data extracted from each study (where provided) will include:
Primary outcome – All reported outcomes, primary and secondary relating to our defined outcomes of safety and effectiveness
Study/Article description: design, methodology (e.g RCT, cohort study), methods of analysis, data type (qualitative/quantitative), publication date, clinical trial registration and study protocol.
Health care personnel and study demographics: e.g role and treatment setting
Care characteristics: primary disease, treatment(s), duration of care
IVTM treatment details: drug administered, frequency, duration, access device used
As our primary aim is to narratively synthesis the evidence, we will not be extracting data relating to risk of bias at this time. However, during data extraction, reviewers will extract data relating to methodology and study quality, to provide a rudimentary indication of evidence quality, and to inform potential further analyses.
There are two phases to our planned data synthesis. Firstly, we will synthesise the included fulltext papers. Data will be extracted under the headings given above into an Excel spreadsheet, and once complete papers will be organised by objective. Each grouping will be narratively reviewed with respect to key themes that appear in multiple papers, significant findings, and any contradictions which may appear, while also drawing attention to any clear gaps in the literature.
Data collected on the methodology of the included papers will be presented in tables for each section, and this data will also be used to give a basic judgement on the overall quality of evidence. Each section will also include a narrative summary of the types of literature being synthesised, and as individual items are discussed their format will also be described to ensure the strength of the evidence is clear.
As methodological data will be collected, should sufficient suitable studies be found, additional separate quantitative and qualitative analyses may be carried out.
We will produce a summary of findings addressing the focused objectives listed above. We anticipate high levels of heterogeneity in eligible studies thus ruling out the possibility of meta-analysis. Therefore, the Synthesis Without Meta-analysis (SWiM) extension to the PRISMA statement checklist will guide the optimal reporting of the work and results12.
A report summarising all major findings aligned with the focused objectives will be provided to the HSE to inform their guideline development. Some dissemination activities will be focused specifically on this audience (e.g. summary infographics, invited talks, etc.). Additionally, we plan to publish our findings in a peer reviewed journal. Should the data allow, we will separate qualitative and quantitative evidence and publish syntheses of both.
The search for this study was carried out in February 2020. Title and abstract screening was completed in early March, and full text screening is expected to be completed by early April.
This review will synthesise best available evidence for the preparation and administration of IVT as demonstrated in existing guidelines, peer-reviewed science, and expert consensus, forming an overview of the current state of the field. Ultimately, the findings will be used to inform the development of a Health Service Executive (HSE) national guideline for the administration of intravenous medications by healthcare professionals in Ireland. As such, a limitation of the study is the specificity of the inclusion and exclusion criteria, which are designed to allow this work to complement existing syntheses and minimise overlap with guidelines that are already integrated into clinical practice.
Open Science Framework: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety? https://doi.org/10.17605/OSF.IO/U3JBW15.
Open Science Framework: PRISMA-P checklist17 for “Study Protocol: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?”. https://doi.org/10.17605/OSF.IO/U3JBW15.
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Intravenous medication errors best practices
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Infusion therapy, peripheral intravenous access, sleep, ambience, neonatal nursing, pediatric nursing.
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Infusion therapy, peripheral intravenous access, sleep, ambience, neonatal nursing, pediatric nursing.
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Intravenous medication errors best practices
Is the rationale for, and objectives of, the study clearly described?
Yes
Is the study design appropriate for the research question?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Not applicable
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Infusion therapy, peripheral intravenous access, sleep, ambience, neonatal nursing, pediatric nursing.
Alongside their report, reviewers assign a status to the article:
Invited Reviewers | ||
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Version 3 (revision) 12 May 21 |
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Version 2 (revision) 10 Dec 20 |
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Version 1 01 May 20 |
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