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Vascular access device type for systemic anti-cancer therapies: a scoping review protocol

06 April 2023
Volume 32 · Issue 7

Abstract

Introduction: Vascular access devices (VADs) are the most common invasive procedure performed in acute medicine and cancer patients undergo multiple invasive vascular access procedures. Our aim is to identify the type of evidence available regarding the best choice of VAD for cancer patients undergoing systemic anti-cancer therapy (SACT). In this article, the authors frame the scoping review protocol used, which will systematically report all published and unpublished literature around the use of VADs for the infusion of SACT in oncology. Inclusion criteria: For studies to be included, they must focus on people or populations aged 18 years or older and report on vascular access in cancer patients. The concept is the variety of VAD use in cancer and reported insertion and post-insertion complications. The context surrounds the intravenous treatment of SACT whether in a cancer centre or non-cancer setting. Methods: The JBI scoping review methodology framework will guide the conduct of this scoping review. Electronic databases (CINAHL, Cochrane, Medline and Embase) will be searched. Grey literature sources and the reference lists of key studies will be reviewed to identify those appropriate for inclusion. No date limits will be used in the searches and studies will be limited to the English language. Two reviewers will independently screen all titles and abstracts and full-text studies for inclusion, and a third reviewer will arbitrate disagreements. All bibliographic data, study characteristics and indicators will be collected and charted using a data extraction tool.

Recent publications highlight the need for better research on the topic of cancer and vascular access (Robinson et al, 2018; Wang et al, 2022). The incidence and prevalence of cancer are growing worldwide, with the number of patients requiring first-line chemotherapy treatment estimated to increase by 53%, from 9.8 million in 2018 to 15 million in 2040. Projected population growth and ageing account for these substantial increases. By 2040, 67% of such patients will inhabit low or middle-income countries (Wilson et al, 2019). Survival rates from cancer have improved, with 5-year survival increasing from 45% to 61% in the past decade and 5-year survival for breast cancer now stands at 82% (Dantas de Araújo Santos Camargo et al, 2021). The emergence of immunotherapy and targeted agents to treat cancer has contributed to this.

These improved outcomes mean, however, that patients often receive multiple SACT infusion therapy regimens. Patients with metastatic disease frequently continue prolonged maintenance therapy, often lasting years. Vascular access is a prerequisite for this; however, long cycles of SACT treatment lead to a narrowing of blood vessels, loss of vasorelaxant effects, as well as preventing anti-inflammatory and vascular reparative actions (Clesham et al, 2021; Santos-Costa et al, 2022). The success of treatment innovations has led to a compelling challenge to reduce the trauma caused to patients’ venous anatomy. Although protocols for VAD choice for SACT are standardised in some settings, it is unclear whether a standardised approach exists worldwide.

There are multiple vascular access device (VAD) types available for the delivery of intravenous systemic anti-cancer therapy (SACT.) The peripheral intravenous catheter/cannula (PIVC) is the most common VAD used during cancer treatment. Repeated cannulations can result in venous depletion, with peripheral vessels becoming thrombosed, resulting in the need for invasive central venous catheters (Ray-Barruel and Alexander, 2023). Widespread use of vascular devices such as peripherally inserted central catheters (PICCs), tunnelled catheters (eg Hickman) or totally implanted ports (PORTs) is accepted. Implanted VADs or catheters can remain in place for many weeks or, in the case of ports, for years. They deliver intravenous therapeutics, medicines and fluids, and enable repeated daily blood sampling (Pittiruti et al, 2023).

Despite widespread VAD use, it is difficult to quantify practice variations (Schults et al, 2021). There is evidence to suggest that VADs are associated with complications, and there is a need to evaluate the efficacy of interventions to reduce them (Carr et al, 2018). The most appropriate VAD for SACT is one possible intervention. Initial complications include arrhythmias, bleeding, malpositioning, air embolism, or injury to vessels and nerves (Gallieni et al, 2008). Prolonged complications include catheter occlusion, venous thromboembolism, bacteraemia, movement, or mechanical dysfunction. These could all lead to treatment delays or cause the patient harm (Paterson et al, 2020).

Recent studies have focused on inherent and modifiable risk factors with PIVC in cancer patients (Abe-Doi et al, 2020; Sasaki et al, 2020; Larsen et al, 2021; Marsh et al, 2021). PIVC outcomes and first-time insertion success with traditional/landmark methods require improvement as 25% of patients will require a second attempt. This needs to be addressed to ensure efficiency and timely delivery of SACT. Modern technologies, for example vein-location devices such as UV, vein finders and ultrasound, identify veins better. Complications related to PIVC, such as phlebitis, extravasation, infiltration and the overall depletion of the peripheral venous network, increase significantly in oncology patients, with incidence rates varying between 34.9% and 50% (Egan et al, 2013; Russell et al, 2014; Pagnutti et al, 2016).

Choosing the appropriate VAD is a critical step in ensuring vessel health and preservation (Gallieni et al, 2008). Therefore, there is a need to explore the breadth of existing literature in the field and to identify and analyse any knowledge gaps.

Scoping review

The authors have chosen to undertake a scoping review to find out more about the body of evidence around type of VAD and SACT. The aim is to synthesise the patient populations, the type of SACT administered, the clinical settings studied, and the outcome measures used. By publishing a scoping review protocol the authors support best practice for evidence synthesis for the review that will follow. Established methodological guidance will be used to ensure rigour in the first phase of a programme of research that intends to improve the evidence base for vascular access in cancer populations.

Process

The author are using the population, concept and context (PCC) framework) to undertake the scoping review; the PCC uses an evidence-synthesis review design that permits broad inclusion criteria of all aspects and approaches to vascular access in cancer patients (see Table 1). A scoping review will support or reject the need for additional evidence synthesis approaches, such as a systematic review with meta-analysis (quantitative) and/or meta synthesis (qualitative).


Table 1. The PCC mnemonic and inclusion criteria
Term Inclusion criteria Exclusion criteria
P
Population Cancer populations of 18 years of age or older Cancer patients under 18 years of age
C
Concept Studies related to vascular access devices Studies focusing on dialysis catheters, umbilical catheters, or arterial catheters
C
Context This scoping review will consider studies that were conducted in cancer centres and non-cancer centres irrespective of gender, race, nationality, and type of disease Case studies Editorials

The JBI reviewer’s manual (Joanna Briggs Institute, https://jbi-global-wiki.refined.site/space/MANUAL) offers specific detail to ensure the scoping review approach is contemporary, up to date and underpinned by robust methodological guidance. This model of knowledge synthesis is aimed at mapping fundamental concepts, types of evidence and gaps in research related to vascular access in cancer (Hallam et al, 2016). Given the predictions of cancer growth and service demand, it is essential that the appropriate VAD is used. Each approach has different safety and risk profiles, as well as effects on a patient’s quality of life, yet evidence for which methods are optimal need to be better understood.

A search of Medline, the Cochrane Database of Systematic Reviews and JBI Evidence Synthesis generated no current systematic reviews or scoping reviews on the topic. However, two randomised control trials (Clemons et al, 2020; McMeekin et al, 2020) were identified, and a complete search may source more. Therefore the authors’ scoping review could justify the need for a systematic review and meta-analysis (Moss et al, 2021).

Review question

The objective of the scoping review is to examine and map the existing literature surrounding VADs used for infusion of SACT in oncology and haematology, with the aim of addressing four research questions:

  • What are the different VAD types used for infusion of SACTs in cancer patients reported in published clinical trials and do clinical trials support the use of certain types of VAD in SACT?
  • Does the choice of VAD reduce incidence of insertion and post-insertion complications such as phlebitis, extravasation, thrombosis, and infection?
  • Does geographical location, and clinical setting such as designated cancer centres versus non-cancer centres, impact on choice of VAD?
  • Does VAD choice impact on quality of life measurement for oncology and haematology patients receiving SACT?

Eligibility criteria

Participants

In terms of the patient population, the scoping review intends to consider only studies that involved cancer patients aged 18 years or older receiving SACT.

Concept

The central concept that the coping review will examine is vascular access use in cancer, and the reported complications. This will include studies related to all types of VAD and reported complications with various VADs and insertion of VADs. The authors will not include arterial and peritoneal catheters and tunnelled devices used for haemodialysis.

Context

The context of this review includes both inpatient and outpatient settings, as long as it is an environment in which SACT are delivered to oncology and haematology patients. Settings may be in designated cancer centres and non-cancer centres. There is no limitation in relation to geographical location, racial background or gender.

Types of sources

The scoping review will consider all sources of published evidence in relation to vascular access and systemic anti-cancer therapy in adult cancer patients. These sources will consider quantitative, qualitative and mixed methods designs, irrespective of methodological approach. Only papers retrieved as English language sources will be included.

Methods

The scoping review protocol will be guided by the JBI methodology. In line with the JBI guideline, this scoping review is intended to elucidate the range of evidence that is available on a topic, regardless of quality (Pham et al, 2014).

Search strategy

The first step was an initial limited search to identify articles related to the topic. With the support of a research librarian, text words and index terms contained in the titles and abstracts of relevant articles helped develop a full search strategy for Embase (see Table 2). The search strategy, including all identified key words and index terms, will be modified for each included database. The authors began work on selecting the initial search terms in October 2022.


Table 2. Search strategy: Embas
No. Query Results
#31 #13 AND #22 AND #31 3,226
#30 #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 2,038,119
#29 ‘infusion*’: ab, ti 372,292
#28 ‘iv drug administration’: ab,ti 90
#27 ‘chemotherapy*’: ab, ti 729,950
#26 ‘Monoclonal antibod*’: ab,ti 247,175
#25 ‘monoclonal antibody’/exp 689553
#24 ‘intravenous drug administration’/exp 394,891
#23 ‘intravenous drug administration’: ab, ti 277
#22 ‘antineoplastic agent*’: ab,ti 7,140
#21 #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 6,678,158
#20 ‘oncolog*’: ab,ti 330,732
#19 ‘tumor*’: ab,ti 2,231,298
#18 ‘tumour*’: ab,ti 412,592
#17 ‘malignan*’: ab,ti 925,418
#16 ‘carcinoma*’: ab,ti 985,065
#15 ‘cancer*’: ab,ti 2,930,071
#14 ‘neoplasm’/exp OR ‘neoplasm*’: ab,ti 5,679,250
#13 ‘malignant neoplasm’/exp 282,141
#12 #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 98,880
#11 ‘vein access’/exp OR ‘vein access’: ti,ab 31,104
#10 ‘central venous access device*’: ab,ti 1,048
#9 ‘vascular access’/exp OR ‘vascular access’: ab,ti 36,669
#8 ‘hickman’: ab, ti 1,249
#7 ‘Peripheral access’: ab, ti 429
#6 ‘cannula’: ab, ti 26,679
#5 ‘peripherally inserted central catheter*’: ab,ti OR ‘centrally inserted central catheter*’:ab,ti 3,011
#4 ‘picc’: ab,ti OR ‘CICC’:ab,ti 3,853
#3 ‘port a access’:ab,ti 795
#2 ‘cvad’:ab,ti 1,512
#1 ‘intravenous access’:ab,ti 1,991

The first step was an initial limited search to identify articles related to the topic. Text words and index terms contained in the titles and abstracts of relevant articles helped develop a full search strategy for Embase (see Table 2). The search strategy, including all identified key words and index terms, will be modified for each included database. The reference list of all incorporated sources of evidence will be screened for further studies. The search will include all studies in the English language, because it would not be feasible to translate non-English studies at this time. Literature search strategies will be conducted using medical subject headings, eg MeSH and text key words related to cancer and VADs. Databases searched for this scoping review will include CINAHL (EBSCO host), Cochrane, Medline (Ovid interface) and Embase (Embase.com).

The search strategy intends to discover both published and unpublished studies. The latter could, for example, be considered if the authors were approached by email or at scientific meetings by institutions or authors, whose work on SACTs meets the inclusion criteria for this scoping review. The search will be extended to Google for grey literature, ie organisational reports, newsletters and other articles not indexed in the library database. The first 100 papers will be searched.

Data extraction

Once the search has been completed, all identified citations will be gathered and uploaded into Rayyan citation manager (http://rayyan.qcri.org) and duplicates removed. A two-step screening process will be executed. Any sources excluded at this point will be documented in the scoping review and an explanation given (Peters et al, 2015). Any differences of opinion that arise between the reviewers at each stage of the selection process will be settled through discussion, or with an additional reviewer/s (VM/PC). The data extraction form (see Table 3) will be used on five evidence sources to ensure the consistency, reliability and appropriateness of the form. Two reviewers (CD and OH) will then extract data from included papers to retrieve at least the following information: author(s), year of publication, journal, country of origin, aims/purpose related to study, study methodology, population, sample size, VAD studied, tool used for knowledge assessment, and outcomes/details (see Table 3).


Table 3. Data extraction instrument
Dimension Details/additional explanation as applicable
General information Authors, year, country of study, language
Study characteristics Aim of intervention, study design, aim of the study
Study participants Description of study population, characteristics of study participants, recruitment strategies, sampling and sample size, age
Type of VAD used  
Outcome details  
Insertion complications  
Post-insertion complications  
Main findings  
Future research recommendations  

The scoping review will include the results of the search and inclusion process and will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review (PRISMA-ScR) flow diagram (Munn et al, 2018). Due to the broad nature of the review, it is possible that the search could yield new terms or concepts. The data extraction tool may then be modified and extended during the review process as charting the findings can be an iterative process (Nyanchoka et al, 2019). Any modifications will be detailed in the scoping review. If necessary, authors of papers will be contacted to request missing or supplementary data, where relevant.

Data analysis and presentation

A PRISMA flow chart will be presented to ensure transparency of the methodological process, including all sources of evidence identified and reason for exclusion of studies (Peters et al, 2022; Tricco et al, 2018). The authors will present the data narratively and tabularly where appropriate. This review is part of ongoing research into venous health and preservation in oncology patients. The research strategy for vascular access in cancer patients outlined in this article will be enhanced when this scoping review has been completed.

Conclusion

The authors have presented a scoping review protocol with some strengths and limitations (see Box 1). Scoping the literature using the per protocol methodology presented in this article will identify research gaps and provide a foundation for further evaluation and research in this field. This review is part of ongoing research into vessel health and preservation in oncology patients. This will improve the science of vascular access for cancer care.

The authors expect the protocol to be ready for publication in the next month and the review to be ready for submission in the summer of 2023.

Box 1.Strengths and limitations of the study

  • This scoping review is considering vascular access in cancer patients receiving systemic anti-cancer therapy (SACT) This scoping review protocol will screen for inclusion literature regarding vascular access in cancer patients receiving SACT. The findings will inform the decision as to whether or not to undertake a systematic review, with meta-analysis and or meta-synthesis
  • This study is guided by established methods as suggested by the Joanna Briggs Institute (https://jbi.global) for conducting scoping reviews
  • Clinical vascular experts, academics, policymakers and a research librarian have been engaged in the development of this review since its inception to certify relevance and scope of the project
  • This review design excludes quality appraisal, risk of bias assessment and meta-analysis, so the authors are limited in terms of any conclusion on the effectiveness of VAD type for SACT

Key points

  • Intravenous systemic anti-cancer treatment advances require reliable vascular access devices and therefore understanding the breadth of research in this area is important
  • Scoping review protocols are an example of best research practice to conduct a scoping review
  • Scoping reviews are exploratory, and they typically address a broad question
  • Scoping reviews are also used to decide whether or not it would be useful to conduct a systematic review with meta-analysis and/or meta-synthesis

CPD reflective questions

  • When is it appropriate to carry out a scoping review?
  • Outline the stages for conducting a scoping review
  • What type of research is included in a scoping review that supports the choice of vascular access device in systemic anti-cancer therapy?