Health-related quality of life and experience measures, to assess patients' experiences of peripheral intravenous catheters: a secondary data analysis.

BACKGROUND: Peripheral intravenous catheters (PIVCs) are essential for successful administration of intravenous treatments. However, insertion failure and PIVC complications are common and negatively impact patients' health-outcomes and experiences. We aimed to assess whether generic (not condition-specific) quality of life and experience measures were suitable for assessing outcomes and experiences of patients with PIVCs. METHODS: We undertook a secondary analysis of data collected on three existing instruments within a large randomised controlled trial, conducted at two adult tertiary hospitals in Queensland, Australia. Instruments included the EuroQol Five Dimension - Five Level (EQ5D-5L), the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General measure (FACIT-TS-G, eight items), and the Australian Hospital Patient Experience Question Set (AHPEQS, 12 items). Responses were compared against two clinical PIVC outcomes of interest: all-cause failure and multiple insertion attempts. Classic descriptives were reported for ceiling and floor effects. Regression analyses examined validity (discrimination). Standardised response mean and effect size (ES) assessed responsiveness (EQ5D-5L, only). RESULTS: In total, 685 participants completed the EQ5D-5L at insertion and 526 at removal. The FACIT-TS-G was completed by 264 and the AHPEQS by 262 participants. Two FACIT-TS-G items and one AHPEQS item demonstrated ceiling effect. Instruments overall demonstrated poor discrimination, however, all-cause PIVC failure was significantly associated with several individual items in the instruments (e.g., AHPEQS, 'unexpected physical and emotional harm'). EQ5D-5L demonstrated trivial (ES < 0.20) responsiveness. CONCLUSIONS: Initial investigation of an existing health-related quality of life measure (EQ5D-5L) and two patient-reported experience measures (FACIT-TS-G; AHPEQS) suggest they are inadequate (as a summary measure) to assess outcomes and experiences for patients with PIVCs. Reliable instruments are urgently needed to inform quality improvement and benchmark standards of care.

Patient reported outcome and experience measures among patients with central venous access devices: a systematic review.

PURPOSE: Patients receiving treatment for solid tumours and haematological malignancies, among other acute and chronic health conditions, are highly dependent upon central venous access devices (CVADs) for administering chemotherapy and other complex therapies; thus, CVADs can meaningfully impact their health outcomes and experiences. This systematic review aimed to identify and critique patient-reported outcome measure (PROM) and patient-reported experience measure (PREM) instruments related to CVADs. METHODS: A systematic review was undertaken, commencing with an electronic search of health databases (April 2022). Studies were eligible if they used a self-reporting instrument (questionnaire) to quantitatively measure patient-reported outcomes and experiences related to CVADs (English only). Using a piloted data-extraction tool, two authors independently identified studies for full review, data extraction, and quality assessment. Data were synthesised narratively. RESULTS: The search yielded 875 titles, of which 41 met the inclusion and no exclusion criteria. Of these, 31 reported results of purpose-built questionnaires; a further six reported results of generic measures used for CVADs; four included both purpose-built and generic measures. Overall study quality was low; only two studies evaluated both content validity and internal consistency. In total, 155 unique PROM items (across 27 studies) were extracted which encompassed five domains (e.g., 'Instrumental activities of daily living'; 'Pain and discomfort'). Similarly, 184 unique PREMs (from 31 studies) included 13 domains (e.g., 'Shared decision-making'; 'Education'). CONCLUSION: Increasingly, research and quality improvement studies about CVADs are incorporating PROM and PREM. These measures are largely purpose-built, however, and their validity and reliability have not been sufficiently established for use. REVIEW REGISTRATION: Prospectively submitted to the International prospective register of systematic reviews (PROSPERO) 05 July 2020.

Development and Preliminary Validation of a Central Venous Access Device-Associated Skin Impairment Classification Tool Using Modified Delphi and Clinimetric Methods.

BACKGROUND: An evidence and consensus-based instrument is needed to classify central venous access device-associated skin impairments. AIM: The aim of this study was to design and evaluate the central venous access device-associated skin impairment classification tool. DESIGN: A two-phase modified Delphi study. METHODS: This two-phase study consisted of a literature review, followed by the development and validation of a classification instrument, by experts in the fields of central venous access devices and wound management (Phase 1). The instrument was tested (Phase 2) using 38 clinical photographs of a range of relevant skin impairments by the same expert panel. The expert panel consisted of registered nurses who were clinical researchers (n = 4) and clinical experts (n = 3) with an average of 24 years of nursing and research experience and 11 years of experience in wound management. Measures to assess preliminary content validity and inter-rater reliability were used. RESULTS: The instrument consists of five overarching aetiological classifications, including contact dermatitis, mechanical injury, infection, pressure injury and complex clinical presentation, with 14 associated subcategory diagnoses (e.g., allergic dermatitis, skin tear and local infection), with definitions and signs and symptoms. High agreement was achieved for preliminary scale content validity and item content validity (I-CVI = 1). Inter-rater reliability of aetiologies was high. The overall inter-rater reliability of individual definitions and signs and symptoms had excellent agreement. CONCLUSION: The development and preliminary validation of this classification tool provide a common language to guide the classification and assessment of central venous access device-associated skin impairment. IMPACT: The comprehensive and validated classification tool will promote accurate identification of central venous access device-associated skin impairment by establishing a common language for healthcare providers. The availability of this tool can reduce clinical uncertainty, instances of misdiagnosis and the potential for mismanagement. Consequently, it will play a pivotal role in guiding clinical decision-making, ultimately enhancing the quality of treatment and improving patient outcomes. REPORTING METHOD: The Guidance on Conducting and Reporting Delphi Studies (CREDES) was adhered to. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

An mHealth application for chronic vascular access: A multi-method evaluation.

BACKGROUND: Healthcare consumers require diverse resources to assist their navigation of complex healthcare interactions, however, these resources need to be fit for purpose. AIM: In this study, we evaluated the utility, usability and feasibility of children, families and adults requiring long-term intravenous therapy using a recently developed mobile health application (App), intravenous (IV) Passport. DESIGN: Multi-site, parallel, multi-method, prospective cohort study. METHODS: A multi-site, multi-method study was carried out in 2020-2021, with 46 participants (20 adults, 26 children/family) reporting on their experiences surrounding the use of the IV Passport for up to 6 months. RESULTS: Overall, utility rates were acceptable, with 78.3% (N = 36) using the IV Passport over the follow-up period, with high rates of planned future use for those still active in the project (N = 21; 73%), especially in the child/family cohort (N = 13; 100%). Acceptability rates were high (9/10; IQR 6.5-10), with the IV Passport primarily used for documenting new devices and complications. Thematic analysis revealed three main themes (and multiple subthemes) in the qualitative data: Advocacy for healthcare needs, Complexity of healthcare and App design and functionality. CONCLUSION: Several recommendations were made to improve the end-user experience including 'how to' instructions; and scheduling functionality for routine care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The IV Passport can be safely and appropriately integrated into healthcare, to support consumers. IMPACT: Patient-/parent-reported feedback suggests the Intravenous Passport is a useful tool for record-keeping, and positive communication between patients/parents, and clinicians. REPORTING METHOD: Not applicable. PATIENT CONTRIBUTION: Consumers reported their experiences surrounding the use of the IV Passport for up to 6 months.

An mHealth application for chronic vascular access: Consumer led co-creation.

PURPOSE: Children with chronic and complex health conditions frequently need intravenous devices. The current approach to intravenous device selection, insertion, and monitoring is inconsistent, and healthcare consumers are often negatively affected by siloed health information, and poor future planning. Despite child- and family-centred care being recognised as a pillar of paediatric nursing care, limited implementation for vascular access device planning and management is evident. DESIGN AND METHODS: To address this, we conducted a multi-phased approach to co-create, then evaluate, a mobile health (mHealth) application: IV Passport. Co-creation involved a prioritisation survey, followed by a Passport advisory panel consensus meeting. Following confirmation of the required content and features of the Passport, the mHealth application was designed and content validation achieved via survey. RESULTS: The prioritisation survey yielded recommendations for seven features (e.g., graphical presentations of current/past devices). Content for nine device types (e.g., totally implanted ports) was suggested, each with 10 related items (e.g., insertion site). Content items for device-associated complications, future vascular access plans, and educational resources were also suggested. Following design, the application was released through Apple and Android platforms; and adapted to a paper version. Content validation was established; 100% strongly agreed the application was easy to use; 80% agreed/strongly agreed that they would recommend the Passport to others. CONCLUSION: IV Passport embodies effective child- and family-centred care through consumer co-creation to empower patients and families manage vascular access devices. PRACTICE IMPLICATIONS: IV Passport remains active; and can be utilised across many healthcare settings and patient populations.

Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlled trial.

AIM: To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). DESIGN: A single-centre, parallel-group, pilot randomised control trial. METHODS: Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. RESULTS: In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). CONCLUSION: With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. REPORTING METHOD: Study methods and results reported in adherence to the CONSORT Statement. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Safety and efficacy of midline catheters versus peripheral intravenous catheters: A pilot randomized controlled trial.

BACKGROUND: Despite pervasive need for peripheral intravenous catheters, insertion is often difficult, and approximately two thirds fail prematurely. Midline catheters are an alternative long peripheral catheter, inserted in the upper arm, ideal for patients with difficult access. AIM: The aim of this study is to test feasibility of the protocol and compare the efficacy and safety of midline catheters to peripheral intravenous catheters. DESIGN: A parallel-group, pilot randomized controlled trial of adult medical/surgical hospitalized patients, from a single Australian referral hospital. METHODS: Participants with difficult vascular access (≤2 palpable veins) and/or anticipated ≥5 days of peripherally compatible intravenous therapy were recruited between May 2019 and March 2020. Participants were randomized to (1) peripheral intravenous catheter or (2) midline catheter. Primary feasibility outcome measured eligibility, recruitment, protocol adherence, retention and attrition. Primary clinical outcomes measured device insertion failure and post-insertion failure. RESULTS: In total, n = 143 participants (71 peripheral intravenous catheters and 72 midline catheters) were recruited; n = 139 were analysed. Most feasibility criteria were met. Peripheral intravenous catheters had shorter functional dwell time, with higher incidence of post-insertion failure compared to midline catheters. CONCLUSION: Midline catheters appear to be superior for patients with difficult vascular access or receiving prolonged intravenous therapy; a large, multi-centre trial to confirm findings is feasible.

Integrated versus non-integrated peripheral intravenous catheters: a cross-sectional survey of nurse experiences.

BACKGROUND: Integrated peripheral intravenous catheters (PIVCs) demonstrate clinical efficacy, however, device complexity and design differences may be a potential barrier to implementation. AIMS: To assess nurse acceptability of integrated PIVC systems. METHODS: A cross-sectional survey was nested within a multicentre randomised controlled trial. One hundred nurses caring for patients with integrated and non-integrated PIVCs completed a 17-item survey about key differences between devices (eg function and appearance, perceived patient comfort and skin injuries). FINDINGS: Most nurses reported the integrated PIVC wings prevented device movement (80%), achieved patient comfort in areas of flexion (78%), and no patients developed skin injuries (100%). Nurses rated the ease of accessing and overall confidence using the integrated PIVC as significantly higher than the non-integrated design (P<0.001). CONCLUSION: The integrated PIVC received positive feedback from nurses and had few barriers to implementation.

Does longer peripheral intravenous catheter length optimise antimicrobial delivery? Protocol for the LEADER study.

BACKGROUND: Hospitalised patients receiving intravenous antimicrobial therapy require a reliable device through which this is delivered. Short peripheral intravenous catheters (PIVCs) are the default device for antimicrobial therapy but up to half fail before therapy completion, leading to suboptimal drug dosing, patient distress from repeated insertions, and increased healthcare costs. This study will investigate the use of long PIVCs to determine if they are more reliable at delivering antimicrobial therapy. METHODS: A two-arm, parallel randomised controlled trial of hospitalised adults requiring at least 3 days of peripherally compatible intravenous antimicrobials. Participants will be randomised to a short (<4 cm) or long (4.5-6.4 cm) PIVC. After interim analysis ( n=70) for feasibility and safety, 192 participants will be recruited. Primary outcome is disruption to antimicrobial administration from all-cause PIVC failure. Secondary outcomes include: number of devices to complete therapy, patient-reported pain and satisfaction, and a cost analysis. Ethical and regulatory approvals have been received.

Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial.

BACKGROUND: The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters. METHODS: We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device-peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete. FINDINGS: Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI -0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, -0·27% to 0·83%). There were no treatment-related adverse events. INTERPRETATION: Infusion set use can be safely extended to 7 days with resultant cost and workload reductions. FUNDING: Australian National Health and Medical Research Council.

Polyhexamethylene biguanide discs versus unmedicated dressings for prevention of central venous catheter-associated infection in the intensive care unit: A pilot randomised controlled trial to assess protocol safety and feasibility.

BACKGROUND: Central venous catheters are prone to infectious complications, affecting morbidity, mortality and healthcare costs. Polyhexamethylene biguanide-impregnated discs at the catheter insertion site may prevent local and bloodstream infection; however, efficacy has not been established in a critical care setting. OBJECTIVE: The objective of this study was to pilot test polyhexamethylene biguanide-impregnated discs compared to standard unmedicated dressings for central venous catheter infection prevention in critically ill patients. METHODS: This was a single-centre pilot randomised controlled trial. Adults admitted to intensive care requiring a central venous catheter for >72 h were eligible. Patients with a current bloodstream infection, concurrent central venous catheter, chlorhexidine or polyhexamethylene biguanide allergy, or sensitive skin were excluded. Patients were randomised to receive standard central venous catheter dressings with/without polyhexamethylene biguanide discs. OUTCOME MEASURES: The primary outcome was feasibility, defined by patient eligibility, recruitment, retention, protocol adherence, missing data, and staff satisfaction. Secondary outcomes included: central line-associated infection; primary bloodstream infection; local infection; skin complications; device/dressing dwell time; serious adverse events, and cost-effectiveness. RESULTS: Of 309 patients screened, 80 participants were recruited with 98% (n = 78) receiving an internal jugular catheter which dwelled for a median of 5 days (interquartile range = 4.0, 6.0). Feasibility criteria were predominantly met (recruitment 88%; retention 100%; protocol fidelity 91%); however, eligibility criteria were not met (32%; most commonly owing to short predicted catheter dwell). Staff acceptability criteria were met, with 83% of staff scoring dressing application and removal ≥7 on a numerical rating scale. There were no central line-associated bloodstream infections and no local infections. Insertion site itch occurred in 4% (control [n = 0], intervention [n = 3]) of participants, while 32% (24/76) reported pain, and 46% (35/76) tenderness. CONCLUSIONS: Polyhexamethylene biguanide discs appear safe for central venous catheter infection prevention. Feasibility of a large efficacy trial was established with some modifications to screening processes. Large, adequately powered randomised controlled trials are needed to test the infection prevention hypotheses.

Inherent and modifiable risk factors for peripheral venous catheter failure during cancer treatment: a prospective cohort study.

PURPOSE: To identify modifiable and non-modifiable risk factors for peripheral intravenous catheter (PIV) failure among patients requiring intravenous treatment for oncology and haematology conditions. METHODS: A single-centre prospective cohort study was conducted between October 2017 and February 2019. Adult in-patients requiring a PIV for therapy were prospectively recruited from two cancer units at a tertiary hospital in Queensland, Australia. The primary outcome was a composite of complications leading to PIV failure (local and bloodstream infection; occlusion; infiltration/extravasation; leakage; dislodgement; and/or phlebitis). Secondary outcomes were (i) PIV dwell time; (ii) insertion and (iii) failure of a CVAD; (iv) adverse events; (v) length of hospital stay. Outcomes were investigated using Bayesian multivariable linear regression modelling and survival analysis. RESULTS: Of 200 participants, 396 PIVs were included. PIV failure incidence was 34.9%; the most common failure type was occlusion/infiltration (n = 74, 18.7%), then dislodgement (n = 33, 8.3%), and phlebitis (n = 30, 7.6%). While several patient and treatment risk factors were significant in univariable modelling, in the final multivariable model, only the use of non-sterile tape (external to the primary dressing) was significantly associated with decreased PIV dislodgement (hazard ratio 0.06, 95% confidence interval 0.01, 0.48; p = 0.008). CONCLUSION: PIV failure rates among patients receiving cancer treatment are high, the sequelae of which may include delayed treatment and infection. Larger studies on risk factors and interventions to prevent PIV failure in this population are needed; however, the use of secondary securements (such as non-sterile tape) to provide further securement to the primary PIV dressing is particularly important. TRIAL REGISTRATION: Study methods were registered prospectively with the Australian New Zealand Clinical Trials Registry on the 27th March 2017 (ACTRN12617000438358); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372191&isReview=true.

A pilot randomised controlled trial of dressing and securement methods to prevent arterial catheter failure in intensive care.

BACKGROUND: Critically ill patients in an intensive care setting often require arterial catheters for blood pressure monitoring and arterial blood collection. Arterial catheter failure, which manifests in both mechanical and infective forms, remains common. Dressing and securement inadequacies may impact this failure; however, the best method for dressing and securing arterial catheters is yet to be determined. OBJECTIVES: The objective of this study was to establish the feasibility of a definitive randomised controlled trial comparing methods for dressing and securing arterial catheters and to prevent device failure in an adult intensive care setting. METHODS: A pilot, parallel-group, randomised controlled trial was conducted between April 2017 and June 2018. Patients receiving treatment in two adult intensive care units (Queensland, Australia) were eligible for inclusion and were allocated to receive either (i) an integrated securement dressing or (ii) a simple polyurethane dressing (with gauze/foam), applied to their newly inserted arterial catheters. MAIN OUTCOME MEASURES: Primary outcomes were (i) feasibility (defined by pre-established criteria: patient eligibility, consent, protocol adherence, retention, and staff acceptability) and (ii) all-cause arterial catheter failure (a composite of local and bloodstream infection, occlusion, dislodgement, infiltration/extravasation, arterial inflammation, thrombosis, and/or inaccurate trace). Secondary outcomes included: failure type, dwell time, dressing adhesion, adverse event profiles, and staff acceptability. RESULTS: In total, 109 patients were studied (n = 53 integrated securement dressing; n = 56 simple polyurethane). The feasibility criterion was met by most patients (including rates of consent [86%], protocol adherence [93%], and retention [100%]); however, the criteria for patient eligibility were not met (73%). All-cause device failure did not differ significantly between the integrated securement device group (n = 12/53, 23%) and the simple polyurethane group (n = 6/56, 11%) (hazard ratio = 2.39, 95% confidence interval = 0.89-6.37, p = 0.083). CONCLUSIONS: Findings indicate a larger study is feasible, with minor alterations to recruitment methods required. Arterial catheter failure remains unacceptably common; further research to determine optimal dressing/securement practices is urgently needed.

Patient-reported outcome and experience measures for peripheral venous catheters: a scoping review protocol.

PURPOSE: The purpose of this scoping review is to conduct a systematic search and establish the current state of evidence for tools and instruments used to measure self-reported outcomes and experiences, including satisfaction scores, specifically for peripheral venous access devices (PVADs). METHODS: A systematic search of the literature will be conducted using medical databases including: MEDLINE (Ovid); CINAHL (EbscoHost); PubMed (NCBI); and Scopus (Elsevier); Google (Scholar); and the Cochrane Central Register of Controlled Trials. Experimental, and observational studies, published in English, after 1990 will be eligible for inclusion if they: consist of (i) a survey, instrument or tool that is designed to (ii) collect outcome, experience and/or satisfaction data, relating to PVAD insertion, care, maintenance and/or removal, among (iii) adult and paediatric participants. CONCLUSIONS: PVAD-specific patient-reported outcome and experience measures are necessary for researchers, clinicians and policy decision makers to explore more thoroughly the quality of PVAD care provided, and further inform health economic analyses in the context of quality improvement interventions for vascular access devices. This scoping review will establish the existence-or paucity-of instruments to measure these selfreported outcomes and experiences of PVADs, in order to guide value-based healthcare delivery into the future.

Smile - Secure my intravenous line effectively: A pilot randomised controlled trial of peripheral intravenous catheter securement in paediatrics.

AIM: Evaluate the feasibility of an efficacy randomised control trial (RCT) of paediatric peripheral intravenous catheter (PIVC) securement to prevent failure without resultant skin damage. METHODS: A 3-arm, pilot RCT in an Australian paediatric hospital. Random assignment of 330 children to receive (i) bordered polyurethane dressing (BPU) + non-sterile foam (NSF), (ii) integrated securement dressing (ISD) + sterile foam (SF), or (iii) tissue adhesive (TA)+ NSF. Primary outcomes were feasibility and PIVC failure. Secondary outcomes included: skin/bloodstream infection; occlusion; infiltration; dislodgement; phlebitis; dwell; serious adverse events; acceptability and microbial colonisation of catheter tips, wound site, and foam. RESULTS: Most feasibility outcomes were confirmed; 98% of eligible patients consented, 96% received their allocated dressing and no patients were lost to follow up. Eligilbility feasibility (58%) was not met. 11 randomised patients did not require a PIVC. Of 319 patients receiving a PIVC (20,716 PIVC-hours), a significant reduction in PIVC failure was demonstrated with ISD, 31/107 (29%, p = 0.017) compared to BPU, 47/105 (45%). Although not statistically significant, compared to BPU, TA 34/107 (32%, p = 0.052) was associated with less PIVC failure. On Cox regression, no securement intervention significantly reduced PIVC failure. Older age (HR 0.92; 95% confidence interval [CI] 0.88-0.96; p = <0.01), no infection at baseline (HR 0.51; 95% CI 0.34-0.78) and insertion by vascular access specialist (HR 0.40; 95% CI 0.26-0.64) were significantly associated with reduced failure (p < 0.05). CONCLUSION: ISD and TA had reduced PIVC failure compared to BPU. A large efficacy trial to test statistical differences is feasible and needed.

Dressings and securements for the prevention of peripheral intravenous catheter failure in adults (SAVE): a pragmatic, randomised controlled, superiority trial.

BACKGROUND: Two billion peripheral intravenous catheters (PIVCs) are used globally each year, but optimal dressing and securement methods are not well established. We aimed to compare the efficacy and costs of three alternative approaches to standard non-bordered polyurethane dressings. METHODS: We did a pragmatic, randomised controlled, parallel-group superiority trial at two hospitals in Queensland, Australia. Eligible patients were aged 18 years or older and required PIVC insertion for clinical treatment, which was expected to be required for longer than 24 h. Patients were randomly assigned (1:1:1:1) via a centralised web-based randomisation service using random block sizes, stratified by hospital, to receive tissue adhesive with polyurethane dressing, bordered polyurethane dressing, a securement device with polyurethane dressing, or polyurethane dressing (control). Randomisation was concealed before allocation. Patients, clinicians, and research staff were not masked because of the nature of the intervention, but infections were adjudicated by a physician who was masked to treatment allocation. The primary outcome was all-cause PIVC failure (as a composite of complete dislodgement, occlusion, phlebitis, and infection [primary bloodstream infection or local infection]). Analysis was by modified intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000769987. FINDINGS: Between March 18, 2013, and Sept 9, 2014, we randomly assigned 1807 patients to receive tissue adhesive with polyurethane (n=446), bordered polyurethane (n=454), securement device with polyurethane (n=453), or polyurethane (n=454); 1697 patients comprised the modified intention-to-treat population. 163 (38%) of 427 patients in the tissue adhesive with polyurethane group (absolute risk difference -4·5% [95% CI -11·1 to 2·1%], p=0·19), 169 (40%) of 423 of patients in the bordered polyurethane group (-2·7% [-9·3 to 3·9%] p=0·44), 176 (41%) of 425 patients in the securement device with poplyurethane group (-1·2% [-7·9% to 5·4%], p=0·73), and 180 (43%) of 422 patients in the polyurethane group had PIVC failure. 17 patients in the tissue adhesive with polyurethane group, two patients in the bordered polyurethane group, eight patients in the securement device with polyurethane group, and seven patients in the polyurethane group had skin adverse events. Total costs of the trial interventions did not differ significantly between groups. INTERPRETATION: Current dressing and securement methods are commonly associated with PIVC failure and poor durability, with simultaneous use of multiple products commonly required. Cost is currently the main factor that determines product choice. Innovations to achieve effective, durable dressings and securements, and randomised controlled trials assessing their effectiveness are urgently needed. FUNDING: Australian National Health and Medical Research Council.

Nurses' decision-making about intravenous administration set replacement: A qualitative study.

AIMS AND OBJECTIVES: To explore nurses' decision-making regarding intravenous administration set replacement for vascular access device infusions in paediatric and adult clinical settings. BACKGROUND: Intravenous administration sets are routinely replaced at regular intervals in clinical practice with the goal of preventing catheter-related bloodstream infection; however, emerging evidence is challenging traditional hang-time durations. Nurses' perceptions and contextual factors affecting decision-making for administration set replacement have not been assessed previously. DESIGN: Qualitative study using focus groups with contextualism methodology and inductive analysis. METHOD: During November-December 2016, eight semi-structured focus groups were conducted with 38 nurses at two metropolitan hospitals in Queensland, Australia. Interviews were audio-recorded and transcribed. Two authors independently reviewed transcripts and extracted significant statements using Braun and Clarke's 7-step method of thematic analysis. The COREQ checklist provided a framework to report the study methods, context, findings, analysis and interpretation. RESULTS: Five key themes emerged from the analysis: (a) infection prevention, (b) physical safety, (c) patient preference, (d) clinical knowledge and beliefs, and (e) workload. Administration set replacement can be a complex task, particularly when patients have multiple infusions and incompatible medications. Nurses drew on perceptions of patient preference, as well as previous experience, knowledge of peer experts and local policies, to aid their decisions. CONCLUSIONS: Nurses use clinical reasoning to balance patient safety and preferences with competing workplace demands when undertaking administration set replacement. Nurses rely on previous experience, hospital and medication manufacturer policies, and peer experts to guide their practice. RELEVANCE TO CLINICAL PRACTICE: Nurses at times deviate from clinical guidelines in the interests of patient acuity, nurses' experience and workload. The findings of this study indicate nurses also balance considerations of patient preference and safety with these competing demands.

Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma.

Presented here are the 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation. At 5 years, the overall patient population (N = 102) had an estimated overall survival (OS) rate of 41% (95% confidence interval [CI]: 31-51) and progression-free survival (PFS) rate of 22% (95% CI: 13-31). Patients who achieved a complete response (CR) to brentuximab vedotin (N = 34) had estimated OS and PFS rates of 64% (95% CI: 48-80%) and 52% (95% CI: 34-69%), respectively. The median OS and PFS were not reached in CR patients, with 13 patients (38% of all CR patients) remaining in follow-up and in remission at study closure. Of the 13 patients, 4 received consolidative hematopoietic allogeneic stem cell transplant, and 9 (9% of all enrolled patients) remain in sustained CR without receiving any further anticancer therapy after treatment with brentuximab vedotin. Of the patients who experienced treatment-emergent peripheral neuropathy, 88% experienced either resolution (73%) or improvement (14%) in symptoms. These 5-year follow-up data demonstrate that a subset of patients with R/R HL who obtained CR with single-agent brentuximab vedotin achieved long-term disease control and may potentially be cured. The trial was registered at www.clinicaltrials.gov as #NCT00848926.

Prophylactic insertion of large bore peripheral intravenous catheters in maternity patients for postpartum haemorrhage: A cohort study.

BACKGROUND: Insertion of a 16 or 18 gauge peripheral intravenous catheter is a potentially painful intervention but one frequently experienced by pregnant women when admitted to hospital. Although the rationale for this practice is 'in case of an emergency bleed', evidence for using large-bore catheters in this population is absent. AIMS: (i) To identify the proportion of 18 gauge or larger peripheral catheters inserted into maternity patients; and (ii) to investigate the proportion of women who require blood products during their perinatal period. MATERIALS AND METHODS: Data from a sub-set of maternity patients who were included in a study of risk factors for peripheral intravenous access failure were analysed using descriptive statistics. RESULTS: One hundred and fourteen catheters were inserted in 95 women. Of the 95 first-inserted catheters, 84 (88.4%) were 16 or 18 gauge and 69 (82.1%) of these were placed in the hand or wrist. Four women (4%) received blood products, all were for non-urgent transfusions. CONCLUSION: Postpartum haemorrhage requiring a blood transfusion remains a relatively rare event. Comprehensive risk assessment should be undertaken before inserting large-bore catheters in perinatal women. Small veins in the hand and wrist should not be used for large bore catheters.

Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma.

We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years. Median overall survival and progression-free survival were estimated at 40.5 months and 9.3 months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58% (95% CI: 41%, 76%), respectively, in this group (medians not reached). Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control. The trial was registered at www.clinicaltrials.gov as #NCT00848926.