Infusion Therapy Standards - Eunetips

Executive summary Section 1 Introduction and methodology Introduction This report has been produced to support development of an update to the RCN Standards for Infusion Therapy, published in 2010. To ensure this update to the standards are evidence informed, an evidence review was commissioned. This report presents the process and findings of this evidence review and comprises: an introductory section containing the background and methodology of the review; three sections detailing the selection, quality assessment and synthesis of the evidence from a clinical and patient perspective; and a concluding section which assesses the findings and implications. Background The RCN Standards for Infusion Therapy (2010) has proved a popular document and is referenced in numerous publications nationally as an exemplar of best practice. A decision was taken to update the 2010 standards following discussions with stakeholders. Infusion therapy has historically been associated with hospital care but, due to increasing demands, it is now delivered in a variety of settings including community and rural settings, as well as self-administration by patients and carers. In light of this changing health care landscape, there is a need to provide standards for infusion therapy that acknowledge and support the delivery of infusion therapy in different settings, whilst also acknowledging the impact on service provision, nurse workload and patient needs. The 1 1.2 Return to contents Section 2 Phase one of the evidence review (clinical practice) Section 3 Phase two of the evidence review (clinical practice) updated version explicitly refers to practice settings outside of secondary care and, as such, is relevant across the various settings where infusion therapy is delivered across the UK. The expert steering board that was set up to manage the RCN standards update under the auspices of the RCN, commissioned the RCN to conduct an evidence review to underpin the development of the revised standards. The project was partly supported by funding from industry sponsors. To accommodate time and resource constraints, the review was underpinned by a robust methodology of rapid evidence assessment (REA). REA is an established research methodology which can be described as a compromise between the requirements of a systematic review and the need to deliver results within a constrained time period2. The evidence review was a collaborative project managed and conducted by the RCN Research and Innovation (Evidence) Library and professional practice teams, as well as an RCN contractor (Bazian). Aims and objectives The aim of this project was to support the update of the RCN’s Standards for Infusion Therapy (2010) and placed an explicit focus on all settings where infusion therapy is delivered. The objectives of the project were to identify areas with robust/ promising/no evidence, and evidence identifying harmful practice. The project included evidence on RCN Infusion therapy standards – rapid evidence review Section 4 Patient perspectives of infusion therapy Section 5 Summary of evidence and implications Scope the patient perspective of infusion therapy which the authors felt was timely and appropriate in the current health climate. Whilst the purpose of the review was primarily to feed into the infusion standards writing, assessment of the evidence volume, relevance and quality was expected to allow for gaps to be identified in a systematic way and for the identification of areas where professional consensus is required. It was important to ensure that the scope of the literature search and review was tightly defined in order to allow for a robust outcome. The following points outline the approach taken: the scope of the review was to identify evidence on infusion therapy devices and procedures that are linked to outcomes of safety and effectiveness and are within the realm of nursing practice and responsibility there was a particular emphasis on the management of the devices rather than the decision on which to select; management decisions and practices made by health care workers relating to infusion therapy that affect nursing practice were also included any practice setting was included – acute and community care, as well as self-management by patient/carer; the standards that the review supported were developed so as to be relevant across all UK care settings the new standards will not duplicate existing infusion therapy guidance from other organisations; the new standards will complement, add value and demonstrate relative advantage with respect to existing guidance. Research questions Two overarching questions guided the review: 1. What is the latest evidence that can be used to update the previous iteration of the standards for infusion therapy? 2. What are the facilitators and barriers perceived by patients receiving a range of infusion therapies? In addition to the main research question of identifying evidence about infusion therapy that relates to nursing practice and is linked with clinical effectiveness and patient safety outcomes, a number of specific points of research interest were identified as the review process was established and experience with the specific body of evidence progressed. These questions related to various aspects of infusion therapy in line with the 12 areas which comprised the review (Table 2); however, not all of the areas had specific research questions. In line with the last point above, a classification scheme of the content of the standards, as agreed by the steering group, was developed in order to structure evidence needs (see Table 1). The current review was focussed on areas one and four in Table Section 1 Introduction and methodology

Executive summary Section 1 Introduction and methodology 1, whereby evidence was sought in areas of infusion therapy that were nursing specific and where no guidelines existed; and in areas that described the context of the therapy delivery. Table 1: Content classification scheme used to structure evidence needs 1. Nursing-specific practice/no guidelines and/or primary evidence required 2. Nursing-specific practice/guidelines exist 3. Non-nursing-specific practice/guidelines exist from other professions 4. Contextual factors (education, commissioning, patient perspective) Section 2 Phase one of the evidence review (clinical practice) Section 3 Phase two of the evidence review (clinical practice) Search strategy The search strategy was designed and executed by the RCN Library. Three key bibliographic databases (British Nursing Index, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and MEDLINE) were selected on the basis of their relevance to nursing research and the fact that they were immediately and freely available. Searches were trialled on these databases during June 2015 to establish appropriate search terms. The general inclusion criteria were agreed with members of the steering board and are detailed below (Table 3). Table 3: Inclusion criteria There were 12 nursing-specific areas of practice that were agreed as requiring primary evidence and thus formed the focus of the clinical aspect of this evidence review (see Table 2). Table 2: 12 areas of infusion therapy care and management included in the evidence review Add on devices Arterial catheters Blood sampling Central venous access devices Flow control devices Infusion-related bloodstream infection Infusion therapy phlebitis Intraosseous access devices Midline catheters Parenteral nutrition Peripheral access devices and flushing Subcutaneous infusions 1.3 Return to contents Publication date 2010 onwards Geographical scope UK and OECD countries Age range Older adolescents and adults (exclude neonates, infants and children) Language English language Study type RCTs, systematic reviews, meta-analyses and cohort studies All three databases were searched during August 2015 using the agreed search strategy. Each of the twelvei topics in question were combined with a generic infusion therapy set (where appropriate) and then with each of three additional sets of terms i Searches were initially conducted for 13 topics, splitting ‘parenteral nutrition’ into two (infusion equipment and total parenteral nutrition) to make the process more manageable; the results of the two searches were later combined and all the analysis was structured around 12 topics. RCN Infusion therapy standards – rapid evidence review Section 4 Patient perspectives of infusion therapy Section 5 Summary of evidence and implications (research designs; standards; complications and adverse events), producing three sets of results per database for each topic. The detailed search strategy and process can be found in Appendix A at the close of this section. The focus of the search was on primary studies of experimental designs and systematic reviews. In addition, searches were conducted on existing published standards or guidelines to ensure coverage of good or accepted practice. Sifting Following the searches, all references were initially sifted for relevance. This was followed by a two-phase review of the clinical evidence. Phase 1 – Randomised controlled trial (RCT) and Systematic review (SR) evidence Phase 2 – Non-RCT and SR evidence In October 2015, a further sift was undertaken to identify any potentially relevant evidence which was originally rejected on the basis of study design. In this phase, RCTs and SRs were removed from the original list of 315 included papers, and the remaining references assessed against the inclusion and exclusion criteria (with the exception that all quantitative research designs were considered), producing 167 studies to be assessed during the second phase of the REA. A similar sifting process was conducted to that discussed above, providing a further 48 studies to be appraised in this phase of the review. Figure 1 presents the sifting process and Section 3 of this document contains details of the full study. Additional search: patient experiences Phase 1 involved a sift on the basis of design, including only RCTs and SRs and removal of duplicates. The remaining studies were assessed against the predetermined inclusion and exclusion criteria. Full text versions of studies which met all inclusion criteria – or where a decision could not be made based on title and abstract – were obtained where available, and were further assessed for inclusion based on the inclusion and exclusion criteria. The sponsors also provided a number of references, of which four studies were included, resulting in 56 studies being assessed in Phase 1 of the review. The sifting process is presented in Figure 1 and the full study is detailed in Section 2 of this document. An additional literature review to locate references relating to the patient experience of infusion therapy was carried out during September and October 2015. The databases searched were British Nursing Index, CINAHL and MEDLINE and the inclusion criteria were the same as those identified in the standards infusion review, with the exception of the research design limitation which was not applied. Searches were trialled in early September in order to establish appropriate terms for the patient experience element of the search, and to reflect differences in database structure and vocabulary. In addition, supplementary terms were identified from the Warwick Patient Experiences Framework (WaPEF)3; these were included in the search terms and were combined with the infusion set terms Section 1 Introduction and methodology

Executive summary Section 1 Introduction and methodology from the clinical review to produce an overall picture of patient views. In addition, the following areas were also investigated using the patient experiences sets, which resulted in a total of six lists of references on patient experiences for each database: parenteral nutrition chemotherapy infusions (intrathecal and intravenous) insulin blood transfusions renal infusions (dialysis). Section 2 Phase one of the evidence review (clinical practice) Section 3 Phase two of the evidence review (clinical practice) Section 4 Patient perspectives of infusion therapy Section 5 Summary of evidence and implications Figure 1: Study selection procedure for all phases of review Phase 1 1,824 studies identified from electronic search Patient perspective Phase 2 315 retained after first sift for relevance 224 studies considered for Phase 2 of review (non RCT and SR) 446 studies identified from electronic search 91 retained after sift on design and duplications (SR and RCT) 167 retained after first sift for relevance 90 retained after first sift on relevance and duplications 73 retained after sift on inclusion and exclusion criteria 68 retained after sift on inclusion and exclusion criteria and duplications 63 retained after sift on inclusion and exclusion criteria The sifting process is presented in Figure 1 and the full study is detailed in Section 4. Quality appraisal and data extraction Critical appraisal of clinical evidence is a technical procedure that follows generally agreed principles4. Appropriate tools were selected during each review based on the research papers being appraised. Details of quality appraisal and data extraction procedures are provided in each individual report. The evidence identified in Phase 1 of the process was reviewed and the report was produced by an information specialist, operating in an outsourced contract under the auspices of the RCN. The evidence review for Phase 2 and the patient perspective was conducted directly by the RCN. 1.4 Return to contents 4 studies identified from sponsors’ submissions One study identified from sponsors’ submissions 77 full text retrieved 61 full text retrieved (8 unavailable) 42 full text retrieved (21 unobtainable) 56 studies included in Phase 1 of review 48 studies included in Phase 2 of review 22 studies included in patient perspectives review RCN Infusion therapy standards – rapid evidence review Section 1 Introduction and methodology

Executive summary Section 1 Introduction and methodology Data mapping and synthesis During each phase of the review, relevant evidence was mapped to provide an overall picture of the available evidence in each area. Results were then synthesised in order to produce an assessment of the strength and volume of evidence relating to each area. Three reports have been produced in relation to the three separate searches and analyses carried out in-house and externally (RCT and SR evidence; other quantitative evidence; patient perspective). The final section synthesises all of the evidence and offers an indication of where the volume and strength of the evidence is higher and identifies were gaps exist. Section 2 Phase one of the evidence review (clinical practice) Section 3 Phase two of the evidence review (clinical practice) Section 4 Patient perspectives of infusion therapy Section 5 Summary of evidence and implications References 1. Royal College of Nursing (2010) Standards for Infusion Therapy, London: RCN. 2. Thomas J, Newman M and Oliver S (2013) Rapid evidence assessments of research to inform social policy: taking stock and moving forward, Evidence and Policy, 9(1), pp.5-27. 3. Staniszewska S, Boardman F, Gunn L, Roberts J, Clay D, Seers K, Brett J, Avital L, Bullock I and O’Flynn N (2014) The Warwick Patient Experiences Framework: patient-based evidence in clinical guidelines, International Journal for Quality in Health Care, 26(2), pp.151-157. 4. Greenhalgh T (1997) How to read a paper: getting your bearings (deciding what the paper is about), British Medical Journal, 315(7102), pp.243-246. 1.5 Return to contents RCN Infusion therapy standards – rapid evidence review Section 1 Introduction and methodology

Executive summary Section 1 Introduction and methodology Appendix A Detailed search strategy The general inclusion criteria are detailed below. Inclusion criteria: Section 2 Phase one of the evidence review (clinical practice) Section 3 Phase two of the evidence review (clinical practice) selection of English-language international journals. It includes selective content from medical, allied health and management titles. The database is updated monthly, and for core UK nursing and midwifery it is the most up-to-date resource available. Publication date: Work published from 2010 onwards Cumulative Index to Nursing and Allied Health Literature (CINAHL Plus) Geographical scope: UK and OECD countries (members of the Organisation for Economic Co-operation and Development, an intergovernmental economic organisation with 35 member states) CINAHL Plus provides bibliographic references to journal articles from hundreds of nursing and allied health journals from the UK, USA and other countries, dating back to 1960. Topics covered include nursing, biomedicine, health sciences librarianship, alternative/complementary medicine, consumer health and 17 allied health disciplines. Age range: Older adolescents and adults (exclude neonates, infants, and children) Language: English language Study type: RCTs, systematic reviews, meta-analyses and cohort studies The British Nursing Index, CINAHL and MEDLINE were searched during August 2015 using the search strategy agreed in advance. British Nursing Index The British Nursing Index (BNI) is a leading UK nursing database providing bibliographic references to journal articles from all the major British nursing and midwifery journals, as well as a 1.6 Return to contents Section 4 Patient perspectives of infusion therapy Section 5 Summary of evidence and implications animal science as well as biophysics and chemistry. Journal articles are covered from 1946 to the present. Topics searched The content of the standards was specified by the RCN Infusion Therapy Standards Project Board and the need for evidence was identified in the following 13 areas: infusion equipment – add on devices infusion equipment – flow control devices infusion equipment – parenteral nutrition peripheral access devices management of midline catheters MEDLINE management of central venous access devices MEDLINE is the US National Library of Medicine’s bibliographic database and indexes the latest articles from more than 3,900 biomedical journals published in more than 70 countries. management of arterial catheters intraosseous access subcutaneous injection (hypodermocylsis) The subject scope of MEDLINE is biomedicine and health, broadly defined to encompass those areas of the life sciences, behavioural sciences, chemical sciences, and bioengineering needed by health professionals and others engaged in basic research and clinical care, public health, health policy development, or related educational activities. MEDLINE also covers life sciences vital to biomedical practitioners, researchers, and educators, including aspects of biology, environmental science, marine biology, plant and parenteral nutrition – total parenteral nutrition, home parenteral nutrition and infection control blood sampling phlebitis infusion-related blood stream infections. RCN Infusion therapy standards – rapid evidence review The topics in question were combined with the infusion therapy set (where appropriate) and then with each of the other sets of terms (research designs; standards; complications and adverse events), producing three sets of results per database for each topic. The precise search strategies used with each of the bibliographic databases are specified below; the search strategy for each database reflects the differences in database structure and vocabulary. Search strategy: BNI Research designs were picked up by the following set of terms: (“random* control* trial*” or “quantitative research” or “systematic review*” or “clinical trial*” or “evidence review*” or “cohort stud*” or “case-control*” or “meta-analysis” or research). Standards, guidelines, protocols, competencies and best/recommended practice were picked up by the following set of terms: (su(standards and guidelines) or recommendations or “recommended practice” or “best practice” or benchmarking or protocol* or legislation or competenc* or “clinical effectiveness” or su(quality assurance)). Complications, patient safety, adverse events, clinical errors or substandard practice were picked up by the following set of terms: (“patient* safety” or su(occupational health and safety) or “adverse effect*” or “adverse Section 1 Introduction and methodology

Executive summary Section 1 Introduction and methodology event*” or “critical incident*” or “human error*” or complication* or malpractice or “clinical error*” or “bad practice” or “poor practice” or “substandard care”). Methods of infusion and intravenous therapy were picked up by the following set of terms although these sometimes overlapped with the 13 individual search topics (listed below) so were not always required: “infusion therap*” or su(intravenous therapy) or “infusion pump*” or “peripheral access” or “central access” or central venous” or midline* or picc* or “vascular access” or parenteral or subcutaneous*. Search strategy: CINAHL Research designs set: (“random* control* trial*” or “quantitative research” or “systematic review*” or “clinical trial*” or “evidence review*” or MH”Prospective Studies ” or MH”Case Control Studies ” or “meta-analysis” or research). Standards set: (MM”Practice Guidelines” or standards or recommendations or “recommended practice” or “best practice” or MM”Benchmarking” or MM”Nursing Protocols” or MM”Protocols” or MH”Legislation ” or competen* or MM”Clinical Effectiveness” or MH”Quality Assurance ”). 1.7 Return to contents Section 2 Phase one of the evidence revie

Infusion therapy standards Rapid evidence review Executive summary Section 1 Introduction and methodology Section 2 Phase one of the evidence review (clinical practice) . relates to nursing practice and is linked with clinical effectiveness and patient safety outcomes,