Effect of supplements/intensive nutrition on pressure ulcer healing: a multicentre, randomised controlled study.

OBJECTIVE: To investigate the effectiveness of an intensive nutrition intervention or use of wound healing supplements compared with standard nutritional care in pressure ulcer (PU) healing in hospitalised patients. METHOD: Adult patients with a Stage II or greater PU and predicted length of stay (LOS) of at least seven days were eligible for inclusion in this pragmatic, multicentre, randomised controlled trial (RCT). Patients with a PU were randomised to receive either: standard nutritional care (n=46); intensive nutritional care delivered by a dietitian (n=42); or standard care plus provision of a wound healing nutritional formula (n=43). Relevant nutritional and PU parameters were collected at baseline and then weekly or until discharge. RESULTS: Of the 546 patients screened, 131 were included in the study. Participant mean age was 66.1±16.9 years, 75 (57.2%) were male and 50 (38.5%) were malnourished at recruitment. Median length of stay was 14 (IQR: 7-25) days and 62 (46.7%) had ≥2 PUs at the time of recruitment. Median change from baseline to day 14 in PU area was -0.75cm2 (IQR: -2.9_-0.03) and mean overall change in Pressure Ulcer Scale for Healing (PUSH) score was -2.9 (SD 3.2). Being in the nutrition intervention group was not a predictor of change in PUSH score, when adjusted for PU stage or location on recruitment (p=0.28); it was not a predictor of PU area at day 14, when adjusted for PU stage or area on recruitment (p=0.89) or PU stage and PUSH score on recruitment (p=0.91), nor a predictor of time to heal. CONCLUSION: This study failed to confirm a significant positive impact on PU healing of use of an intensive nutrition intervention or wound healing supplements in hospitalised patients. Further research that focuses on practical mechanisms to meet protein and energy requirements is needed to guide practice.

Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial.

OBJECTIVE: To determine the effectiveness of closed incision negative pressure wound therapy (NPWT) compared with standard dressings in preventing surgical site infection (SSI) in obese women undergoing caesarean section. DESIGN: Multicentre, pragmatic, randomised, controlled, parallel group, superiority trial. SETTING: Four Australian tertiary hospitals between October 2015 and November 2019. PARTICIPANTS: Eligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section. INTERVENTION: 2035 consenting women were randomised before the caesarean procedure to closed incision NPWT (n=1017) or standard dressing (n=1018). Allocation was concealed until skin closure. MAIN OUTCOME MEASURES: The primary outcome was cumulative incidence of SSI. Secondary outcomes included depth of SSI (superficial, deep, or organ/body space), rates of wound complications (dehiscence, haematoma, seroma, bleeding, bruising), length of stay in hospital, and rates of dressing related adverse events. Women and clinicians were not masked, but the outcome assessors and statistician were blinded to treatment allocation. The pre-specified primary intention to treat analysis was based on a conservative assumption of no SSI for a minority of women (n=28) with missing outcome data. Post hoc sensitivity analyses included best case analysis and complete case analysis. RESULTS: In the primary intention to treat analysis, SSI occurred in 75 (7.4%) women treated with closed incision NPWT and in 99 (9.7%) women with a standard dressing (risk ratio 0.76, 95% confidence interval 0.57 to 1.01; P=0.06). Post hoc sensitivity analyses to explore the effect of missing data found the same direction of effect (closed incision NPWT reducing SSI), with statistical significance. Blistering occurred in 40/996 (4.0%) women who received closed incision NPWT and in 23/983 (2.3%) who received the standard dressing (risk ratio 1.72, 1.04 to 2.85; P=0.03). CONCLUSION: Prophylactic closed incision NPWT for obese women after caesarean section resulted in a 24% reduction in the risk of SSI (3% reduction in absolute risk) compared with standard dressings. This difference was close to statistical significance, but it likely underestimates the effectiveness of closed incision NPWT in this population. The results of the conservative primary analysis, multivariable adjusted model, and post hoc sensitivity analysis need to be considered alongside the growing body of evidence of the benefit of closed incision NPWT and given the number of obese women undergoing caesarean section globally. The decision to use closed incision NPWT must also be weighed against the increases in skin blistering and economic considerations and should be based on shared decision making with patients. TRIAL REGISTRATION: ANZCTR identifier 12615000286549.

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.

Peripheral intravenous catheter non-infectious complications in adults: A systematic review and meta-analysis.

AIMS: The aim of this systematic review and meta-analysis was to summarize and quantify peripheral intravenous catheter-related complications. DESIGN: This systematic review is reported by means of the Cochrane process for randomized controlled trials and the Meta-analysis of Observation Studies in Epidemiology for cohort studies. DATA SOURCES: The Cochrane Central Register of Controlled Trials, PubMed, CINAHL and EMBASE databases, clinical trial registries such as ClinicalTrials.gov and the reference list of included studies were searched from 2000 -April 2019. REVIEW METHODS: Using a purpose designed data extraction tool, two authors independently identified studies for full review, data extraction and quality assessment. Dichotomous outcomes were pooled after Freeman-Tukey double arcsine transformation using random-effects meta-analysis; estimates of heterogeneity were taken from inverse-variance fixed-effect models. RESULTS: Seventy observational studies and 33 randomized controlled trials were included (76,977 catheters). Peripheral intravenous catheter-related complications were as follows: phlebitis (with definition) 19.3%, phlebitis (without definition) 4.5%, infiltration/extravasation 13.7%, occlusion 8%, leakage 7.3%, pain 6.4% and dislodgement 6.0%. Subgroup analysis found infiltration/extravasation for emergency department-inserted catheters was significantly higher (25.2%; p = .022) than for those inserted in other departments and pain was significantly higher (p < .001) in countries with developing economies compared with developed economies. CONCLUSION: Peripheral intravenous catheter complications are unacceptably common worldwide. This review suggests substantial and multi-specialty efforts are needed to address the sequalae associated with complications. The potential benefits for patients and health services are considerable if complications are reduced. IMPACT: Peripheral intravenous complications interrupt important treatment which can be distressing for patients and result in longer hospital stays with increased healthcare costs. This review found phlebitis and infiltration are the most prevalent reason for catheter failure. These results provide nurses with a strong evidence base for the development of effective interventions for practice which are vital for preventing poor outcomes for patients with peripheral intravenous catheters.

A systematic review of central-line-associated bloodstream infection (CLABSI) diagnostic reliability and error.

OBJECTIVE: To establish the reliability of the application of National Health and Safety Network (NHSN) central-line-associated bloodstream infection (CLABSI) criteria within established reporting systems internationally. DESIGN: Diagnostic-test accuracy systematic review. METHODS: We conducted a search of Medline, SCOPUS, the Cochrane Library, CINAHL (EbscoHost), and PubMed (NCBI). Cohort studies were eligible for inclusion if they compared publicly reported CLABSI rates and were conducted by independent and expertly trained reviewers using NHSN/Centers for Disease Control (or equivalent) criteria. Two independent reviewers screened, extracted data, and assessed risk of bias using the QUADAS 2 tool. Sensitivity, specificity, negative and positive predictive values were analyzed. RESULTS: A systematic search identified 1,259 publications; 9 studies were eligible for inclusion (n = 7,160 central lines). Publicly reported CLABSI rates were more likely to be underestimated (7 studies) than overestimated (2 studies). Specificity ranged from 0.70 (95% confidence interval [CI], 0.58-0.81) to 0.99 (95% CI, 0.99-1.00) and sensitivity ranged from 0.42 (95% CI, 0.15-0.72) to 0.88 (95% CI, 0.77-0.95). Four studies, which included a consecutive series of patients (whole cohort), reported CLABSI incidence between 9.8% and 20.9%, and absolute CLABSI rates were underestimated by 3.3%-4.4%. The risk of bias was low to moderate in most included studies. CONCLUSIONS: Our findings suggest consistent underestimation of true CLABSI incidence within publicly reported rates, weakening the validity and reliability of surveillance measures. Auditing, education, and adequate resource allocation is necessary to ensure that surveillance data are accurate and suitable for benchmarking and quality improvement measures over time. REGISTRATION: Prospectively registered with International prospective register of systematic reviews (PROSPERO ID CRD42015021989; June 7, 2015). https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID%3dCRD42015021989.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). While existing evidence for the effectiveness of NPWT remains uncertain, new trials necessitated an updated review of the evidence for the effects of NPWT on postoperative wounds healing by primary closure. OBJECTIVES: To assess the effects of negative pressure wound therapy for preventing surgical site infection in wounds healing through primary closure. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in February 2018. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions on language, publication date, or setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT. DATA COLLECTION AND ANALYSIS: Four review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to GRADE methodology. MAIN RESULTS: In this second update we added 25 intervention trials, resulting in a total of 30 intervention trials (2957 participants), and two economic studies nested in trials. Surgeries included abdominal and colorectal (n = 5); caesarean section (n = 5); knee or hip arthroplasties (n = 5); groin surgery (n = 5); fractures (n = 5); laparotomy (n = 1); vascular surgery (n = 1); sternotomy (n = 1); breast reduction mammoplasty (n = 1); and mixed (n = 1). In three key domains four studies were at low risk of bias; six studies were at high risk of bias; and 20 studies were at unclear risk of bias. We judged the evidence to be of low or very low certainty for all outcomes, downgrading the level of the evidence on the basis of risk of bias and imprecision.Primary outcomesThree studies reported mortality (416 participants; follow-up 30 to 90 days or unspecified). It is uncertain whether NPWT has an impact on risk of death compared with standard dressings (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.25 to 1.56; very low-certainty evidence, downgraded once for serious risk of bias and twice for very serious imprecision).Twenty-five studies reported on SSI. The evidence from 23 studies (2533 participants; 2547 wounds; follow-up 30 days to 12 months or unspecified) showed that NPWT may reduce the rate of SSIs (RR 0.67, 95% CI 0.53 to 0.85; low-certainty evidence, downgraded twice for very serious risk of bias).Fourteen studies reported dehiscence. We combined results from 12 studies (1507 wounds; 1475 participants; follow-up 30 days to an average of 113 days or unspecified) that compared NPWT with standard dressings. It is uncertain whether NPWT reduces the risk of wound dehiscence compared with standard dressings (RR 0.80, 95% CI 0.55 to 1.18; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision).Secondary outcomesWe are uncertain whether NPWT increases or decreases reoperation rates when compared with a standard dressing (RR 1.09, 95% CI 0.73 to 1.63; 6 trials; 1021 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision) or if there is any clinical benefit associated with NPWT for reducing wound-related readmission to hospital within 30 days (RR 0.86, 95% CI 0.47 to 1.57; 7 studies; 1271 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision). It is also uncertain whether NPWT reduces incidence of seroma compared with standard dressings (RR 0.67, 95% CI 0.45 to 1.00; 6 studies; 568 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision). It is uncertain if NPWT reduces or increases the risk of haematoma when compared with a standard dressing (RR 1.05, 95% CI 0.32 to 3.42; 6 trials; 831 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision. It is uncertain if there is a higher risk of developing blisters when NPWT is compared with a standard dressing (RR 6.64, 95% CI 3.16 to 13.95; 6 studies; 597 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision).Quality of life was not reported separately by group but was used in two economic evaluations to calculate quality-adjusted life years (QALYs). There was no clear difference in incremental QALYs for NPWT relative to standard dressing when results from the two trials were combined (mean difference 0.00, 95% CI -0.00 to 0.00; moderate-certainty evidence).One trial concluded that NPWT may be more cost-effective than standard care, estimating an incremental cost-effectiveness ratio (ICER) value of GBP 20.65 per QALY gained. A second cost-effectiveness study estimated that when compared with standard dressings NPWT was cost saving and improved QALYs. We rated the overall quality of the reports as very good; we did not grade the evidence beyond this as it was based on modelling assumptions. AUTHORS' CONCLUSIONS: Despite the addition of 25 trials, results are consistent with our earlier review, with the evidence judged to be of low or very low certainty for all outcomes. Consequently, uncertainty remains about whether NPWT compared with a standard dressing reduces or increases the incidence of important outcomes such as mortality, dehiscence, seroma, or if it increases costs. Given the cost and widespread use of NPWT for SSI prophylaxis, there is an urgent need for larger, well-designed and well-conducted trials to evaluate the effects of newer NPWT products designed for use on clean, closed surgical incisions. Such trials should initially focus on wounds that may be difficult to heal, such as sternal wounds or incisions on obese patients.

Clinically-indicated replacement versus routine replacement of peripheral venous catheters.

BACKGROUND: US Centers for Disease Control guidelines recommend replacement of peripheral intravenous catheters (PIVC) no more frequently than every 72 to 96 hours. Routine replacement is thought to reduce the risk of phlebitis and bloodstream infection. Catheter insertion is an unpleasant experience for patients and replacement may be unnecessary if the catheter remains functional and there are no signs of inflammation or infection. Costs associated with routine replacement may be considerable. This is the third update of a review first published in 2010. OBJECTIVES: To assess the effects of removing peripheral intravenous catheters when clinically indicated compared with removing and re-siting the catheter routinely. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 18 April 2018. We also undertook reference checking, and contacted researchers and manufacturers to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials that compared routine removal of PIVC with removal only when clinically indicated, in hospitalised or community-dwelling patients receiving continuous or intermittent infusions. DATA COLLECTION AND ANALYSIS: Three review authors independently reviewed trials for inclusion, extracted data, and assessed risk of bias using Cochrane methods. We used GRADE to assess the overall evidence certainty. MAIN RESULTS: This update contains two new trials, taking the total to nine included studies with 7412 participants. Eight trials were conducted in acute hospitals and one in a community setting. We rated the overall certainty of evidence as moderate for most outcomes, due to serious risk of bias for unblinded outcome assessment or imprecision, or both. Because outcome assessment was unblinded in all of the trials, none met our criteria for high methodological quality.Primary outcomesSeven trials (7323 participants), assessed catheter-related bloodstream infection (CRBSI). There is no clear difference in the incidence of CRBSI between the clinically indicated (1/3590) and routine change (2/3733) groups (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.08 to 4.68), low-certainty evidence (downgraded twice for serious imprecision).All trials reported incidence of thrombophlebitis and we combined the results from seven of these in the analysis (7323 participants). We excluded two studies in the meta-analysis because they contributed to high heterogeneity. There is no clear difference in the incidence of thrombophlebitis whether catheters were changed according to clinical indication or routinely (RR 1.07, 95% CI 0.93 to 1.25; clinically indicated 317/3590; 3-day change 307/3733, moderate-certainty evidence, downgraded once for serious risk of bias). The result was unaffected by whether the infusion was continuous or intermittent. Six trials provided thrombophlebitis rates by number of device days (32,709 device days). There is no clear difference between groups (RR 0.90, 95% CI 0.76 to 1.08; clinically indicated 248/17,251; 3-day change 236/15,458; moderate-certainty evidence, downgraded once for serious risk of bias).One trial (3283 participants), assessed all-cause blood stream infection (BSI). We found no clear difference in the all-cause BSI rate between the two groups (RR 0.47, 95% CI 0.15 to 1.53; clinically indicated: 4/1593 (0.02%); routine change 9/1690 (0.05%); moderate-certainty evidence, downgraded one level for serious imprecision).Three trials (4244 participants), investigated costs; clinically indicated removal probably reduces device-related costs by approximately AUD 7.00 compared with routine removal (MD -6.96, 95% CI -9.05 to -4.86; moderate-certainty evidence, downgraded once for serious risk of bias).Secondary outcomesSix trials assessed infiltration (7123 participants). Routine replacement probably reduces infiltration of fluid into surrounding tissues compared with a clinically indicated change (RR 1.16 (95% CI 1.06 to 1.26; routine replacement 747/3638 (20.5%); clinically indicated 834/3485 (23.9%); moderate-certainty evidence, downgraded once for serious risk of bias).Meta-analysis of seven trials (7323 participants), found that rates of catheter failure due to blockage were probably lower in the routine-replacement group compared to the clinically indicated group (RR 1.14, 95% CI 1.01 to 1.29; routine-replacement 519/3733 (13.9%); clinically indicated 560/3590 (15.6%); moderate-certainty evidence, downgraded once for serious risk of bias).Four studies (4606 participants), reported local infection rates. It is uncertain if there are differences between groups (RR 4.96, 95% CI 0.24 to 102.98; clinically indicated 2/2260 (0.09%); routine replacement 0/2346 (0.0%); very low-certainty evidence, downgraded one level for serious risk of bias and two levels for very serious imprecision).One trial (3283 participants), found no clear difference in the incidence of mortality when clinically indicated removal was compared with routine removal (RR 1.06, 95% CI 0.27 to 4.23; low-certainty evidence, downgraded two levels for very serious imprecision).One small trial (198 participants) reported no clear difference in device-related pain between clinically indicated and routine removal groups (MD -0.60, 95% CI -1.44 to 0.24; low-certainty evidence, downgraded one level for serious risk of bias and one level for serious imprecision).The pre-planned outcomes 'number of catheter re-sites per patient', and 'satisfaction' were not reported by any studies included in this review. AUTHORS' CONCLUSIONS: There is moderate-certainty evidence of no clear difference in rates of CRBSI, thrombophlebitis, all-cause BSI, mortality and pain between clinically indicated or routine replacement of PIVC. We are uncertain if local infection is reduced or increased when catheters are changed when clinically indicated. There is moderate-certainty evidence that infiltration and catheter blockage is probably lower when PIVC are changed routinely; and moderate-certainty evidence that clinically indicated removal probably reduces device-related costs. The addition of two new trials for this update found no further evidence to support changing catheters every 72 to 96 hours. Healthcare organisations may consider changing to a policy whereby catheters are changed only if there is a clinical indication to do so, for example, if there were signs of infection, blockage or infiltration. This would provide significant cost savings, spare patients the unnecessary pain of routine re-sites in the absence of clinical indications and would reduce time spent by busy clinicians on this intervention. To minimise PIVC-related complications, staff should inspect the insertion site at each shift change and remove the catheter if signs of inflammation, infiltration, occlusion, infection or blockage are present, or if the catheter is no longer needed for therapy.

Cost of vascular access devices in public hospitals in Queensland.

Objective The aim of this study was to quantify the utilisation of vascular access devices in Queensland public hospitals and their associated cost. Methods Devices were broadly classified into peripheral intravenous catheters, central venous catheters and arterial lines. The number of catheters used was obtained from a central procurement department at Queensland Health and validated using Medicare Benefits Schedule (MBS) claims and/or hospital data from the Australian Institute of Health and Welfare for the same period. Resources consumed included equipment and staff time required to insert and remove catheters. Equipment costs were valued using negotiated hospital prices, and staff time was valued at the fixed industrial award wages in Australia or relevant MBS fees. Device maintenance costs (e.g. dressings) and costs of treating complications were excluded. Results Approximately 2.75million vascular access devices were used in public hospitals in Queensland in 2016, at a total cost of A$59.14million. This comprised a total equipment cost of around A$10.17million and a total labour cost of A$48.85million Conclusion Vascular access is an important component of healthcare expenditure. The present study is the first to characterise and cost vascular access devices in Queensland. Further research is needed on the costs of maintaining device function and of treating complications associated with vascular access. What is known about the topic? The cost of vascular access in Australia has previously been estimated from modelling, using various assumptions, or based on device utilisation in other countries. What does this paper add? For the first time, device utilisation for vascular access in Queensland has been quantified and costed. Results were obtained from reliable sources and validated against other databases. What are the implications for practitioners? Practitioners and managers may now provide accurate estimates about the cost of catheter failure, a potentially preventable problem that affects up to 50% of all catheters placed. Attaching costs to such failure may also stimulate research into how to reduce the problem.

Eight-hour versus 12-h shifts in an ICU: Comparison of nursing responses and patient outcomes.

INTRODUCTION: Controversy remains about the impact of 12-h shift patterns on staff satisfaction and health and on patient outcomes. Consequently, the objective of the study was to investigate the effect on nurses and patients of 8-h rostering compared with 12-h rostering. METHODS: We conducted a two-phase survey. Intensive care nurses completed a purposefully designed 49-item questionnaire, which included open- and closed-ended questions. Phase 1 was conducted during 2015, while the 8-h shift pattern was in place. Data for phase 2 were collected in 2017, approximately 6 months after the trial of 12-h shifts began. We extracted data from the hospital's adverse event register to compare patient outcomes between the two phases. RESULTS: A total of 152/193 (78.8%) surveys were returned in phase 1. In phase 2, the response rate was 114/188 (60.6%). The proportion of nurses satisfied with the roster increased 3-fold after the introduction of 12-h shifts; risk ratios 3.36 (95% confidence intervals 2.62 to 4.28). Communication with all levels of senior staff improved, and the number of hours of professional development leave increased with the 12-h roster phase 1, 358 h versus 538 h in phase 2 (p = <0.0001). Most respondents believed that 12-h shifts would be beneficial for their health, and this belief was validated by official leave records; there was a reduction of 69 days for sick leave and 216 days for family leave. Adverse outcomes for patients were similar in the two periods. CONCLUSION: Twelve-hour shifts are popular with ICU nurses, days lost to sick and family leave are reduced, and patient outcomes are not compromised.

Dressings and topical agents for preventing pressure ulcers.

BACKGROUND: Pressure ulcers, localised injuries to the skin or underlying tissue, or both, occur when people cannot reposition themselves to relieve pressure on bony prominences. These wounds are difficult to heal, painful, expensive to manage and have a negative impact on quality of life. Prevention strategies include nutritional support and pressure redistribution. Dressing and topical agents aimed at prevention are also widely used, however, it remains unclear which, if any, are most effective. This is the first update of this review, which was originally published in 2013. OBJECTIVES: To evaluate the effects of dressings and topical agents on pressure ulcer prevention, in people of any age, without existing pressure ulcers, but considered to be at risk of developing one, in any healthcare setting. SEARCH METHODS: In March 2017 we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, MEDLINE (In-Process & Other Non-Indexed Citations), Embase, and EBSCO CINAHL Plus. We searched clinical trials registries for ongoing trials, and bibliographies of relevant publications to identify further eligible trials. There was no restriction on language, date of trial or setting. In May 2018 we updated this search; as a result several trials are awaiting classification. SELECTION CRITERIA: We included randomised controlled trials that enrolled people at risk of pressure ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias and extracted data. MAIN RESULTS: The original search identified nine trials; the updated searches identified a further nine trials meeting our inclusion criteria. Of the 18 trials (3629 participants), nine involved dressings; eight involved topical agents; and one included dressings and topical agents. All trials reported the primary outcome of pressure ulcer incidence.Topical agentsThere were five trials comparing fatty acid interventions to different treatments. Two trials compared fatty acid to olive oil. Pooled evidence shows that there is no clear difference in pressure ulcer incidence between groups, fatty acid versus olive oil (2 trials, n=1060; RR 1.28, 95% CI 0.76 to 2.17; low-certainty evidence, downgraded for very serious imprecision; or fatty acid versus standard care (2 trials, n=187; RR 0.70, 95% CI 0.41 to 1.18; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Trials reported that pressure ulcer incidence was lower with fatty acid-containing-treatment compared with a control compound of trisostearin and perfume (1 trial, n=331; RR 0.42, 95% CI 0.22 to 0.80; low-certainty evidence, downgraded for serious risk of bias and serious imprecision). Pooled evidence shows that there is no clear difference in incidence of adverse events between fatty acids and olive oil (1 trial, n=831; RR 2.22 95% CI 0.20 to 24.37; low-certainty evidence, downgraded for very serious imprecision).Four trials compared further different topical agents with placebo. Dimethyl sulfoxide (DMSO) cream may increase the risk of pressure ulcer incidence compared with placebo (1 trial, n=61; RR 1.99, 95% CI 1.10 to 3.57; low-certainty evidence; downgraded for serious risk of bias and serious imprecision). The other three trials reported no clear difference in pressure ulcer incidence between active topical agents and control/placebo; active lotion (1 trial, n=167; RR 0.73, 95% CI 0.45 to 1.19), Conotrane (1 trial, n=258; RR 0.74, 95% CI 0.52 to 1.07), Prevasore (1 trial, n=120; RR 0.33, 95% CI 0.04 to 3.11) (very low-certainty evidence, downgraded for very serious risk of bias and very serious imprecision). There was limited evidence from one trial to determine whether the application of a topical agent may delay or prevent the development of a pressure ulcer (DermalexTM 9.8 days vs placebo 8.7 days). Further, two out of 76 reactions occurred in the DermalexTM group compared with none out of 91 in the placebo group (RR 6.14, 95% CI 0.29 to 129.89; very low-certainty evidence; downgraded for very serious risk of bias and very serious imprecision).DressingsSix trials (n = 1247) compared a silicone dressing with no dressing. Silicone dressings may reduce pressure ulcer incidence (any stage) (RR 0.25, 95% CI 0.16 to 0.41; low-certainty evidence; downgraded for very serious risk of bias). In the one trial (n=77) we rated as being at low risk of bias, there was no clear difference in pressure ulcer incidence between silicone dressing and placebo-treated groups (RR 1.95, 95% CI 0.18 to 20.61; low-certainty evidence, downgraded for very serious imprecision).One trial (n=74) reported no clear difference in pressure ulcer incidence when a thin polyurethane dressing was compared with no dressing (RR 1.31, 95% CI 0.83 to 2.07). In the same trial pressure ulcer incidence was reported to be higher in an adhesive foam dressing compared with no dressing (RR 1.65, 95% CI 1.10 to 2.48). We rated evidence from this trial as very low certainty (downgraded for very serious risk of bias and serious imprecision).Four trials compared other dressings with different controls. Trials reported that there was no clear difference in pressure ulcer incidence between the following comparisons: polyurethane film and hydrocolloid dressing (n=160, RR 0.58, 95% CI 0.24 to 1.41); Kang' huier versus routine care n=100; RR 0.42, 95% CI 0.08 to 2.05); 'pressure ulcer preventive dressing' (PPD) versus no dressing (n=74; RR 0.18, 95% CI 0.04 to 0.76) We rated the evidence as very low certainty (downgraded for very serious risk of bias and serious or very serious imprecision). AUTHORS' CONCLUSIONS: Most of the trials exploring the impact of topical applications on pressure ulcer incidence showed no clear benefit or harm. Use of fatty acid versus a control compound (a cream that does not include fatty acid) may reduce the incidence of pressure ulcers. Silicone dressings may reduce pressure ulcer incidence (any stage). However the low level of evidence certainty means that additional research is required to confirm these results.

The Indigenous Birthing in an Urban Setting study: the IBUS study : A prospective birth cohort study comparing different models of care for women having Aboriginal and Torres Strait Islander babies at two major maternity hospitals in urban South East Queensland, Australia.

BACKGROUND: With persisting maternal and infant health disparities, new models of maternity care are needed to meet the needs of Aboriginal and Torres Strait Islander people in Australia. To date, there is limited evidence of successful and sustainable programs. Birthing on Country is a term used to describe an emerging evidence-based and community-led model of maternity care for Indigenous families; its impact requires evaluation. METHODS: Mixed-methods prospective birth cohort study comparing different models of care for women having Aboriginal and Torres Strait Islander babies at two major maternity hospitals in urban South East Queensland (2015-2019). Includes women's surveys (approximately 20 weeks gestation, 36 weeks gestation, two and six months postnatal) and infant assessments (six months postnatal), clinical outcomes and cost comparison, and qualitative interviews with women and staff. DISCUSSION: This study aims to evaluate the feasibility, acceptability, sustainability, clinical and cost-effectiveness of a Birthing on Country model of care for Aboriginal and Torres Strait Islander families in an urban setting. If successful, findings will inform implementation of the model with similar communities. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry # ACTRN12618001365257 . Registered 14 August 2018 (retrospectively registered).

Expert versus generalist inserters for peripheral intravenous catheter insertion: a pilot randomised controlled trial.

BACKGROUND: Peripheral intravenous catheters (PVCs) are essential invasive devices, with 2 billion PVCs sold each year. The comparative efficacy of expert versus generalist inserter models for successful PVC insertion and subsequent reliable vascular access is unknown. METHODS: A single-centre, parallel-group, pilot randomised controlled trial (RCT) of 138 medical/surgical patients was conducted in a large tertiary hospital in Australia to compare PVC insertion by (1) a vascular access specialist (VAS) or (2) any nursing or medical clinician (generalist model). The primary outcome was the feasibility of a larger RCT as established by predetermined criteria (eligibility, recruitment, retention, protocol adherence). Secondary outcomes were PVC failure: phlebitis, infiltration/extravasation, occlusion, accidental removal or partial dislodgement, local infection or catheter-related bloodstream infection; dwell time; insertion success, insertion attempts; patient satisfaction; and procedural cost-effectiveness. RESULTS: Feasibility outcomes were achieved: 92% of screened patients were eligible; two patients refused participation; there was no attrition or missing outcome data. PVC failure was higher with generalists (27/50, 54%) than with VASs (33/69, 48%) (228 versus 217 per 1000 PVC days; incidence rate ratio 1.05, 95% confidence interval 0.61-1.80). There were no local or PVC-related infections in either group. All PVCs (n = 69) were successfully inserted in the VAS group. In the generalist group, 19 (28%) patients did not have a PVC inserted. There were inadequate data available for the cost-effectiveness analysis, but the mean insertion procedure time was 2 min in the VAS group and 11 min in the generalist group. Overall satisfaction with the PVC was measured on an 11-point scale (0 = not satisfied and 10 = satisfied) and was higher in the VAS group (n = 43; median = 7) compared to the generalist group (n = 20; median = 4.5). The multivariable model identified medical diagnosis and bed-bound status as being significantly associated with higher PVC failure, and securement with additional non-sterile tape was significantly associated with lower PVC failure. CONCLUSION: This pilot trial confirmed the feasibility and need for a large, multicentre RCT to test these PVC insertion models. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001675415 . Registered on 6 December 2016.

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.

Phlebitis Signs and Symptoms With Peripheral Intravenous Catheters: Incidence and Correlation Study.

This study was undertaken to calculate the incidence of 8 signs and symptoms used for the diagnosis of phlebitis with peripheral intravenous catheters, or short peripheral catheters, and the level of correlation between them. A total of 22 789 daily observations of 6 signs (swelling, erythema, leakage, palpable venous cord, purulent discharge, and warmth) and 2 symptoms (pain and tenderness) were analyzed of 5907 catheter insertion sites. Most signs and symptoms of phlebitis occurred only occasionally or rarely; the incidence of tenderness was highest (5.7%). Correlations were mostly low; warmth correlated strongly with tenderness, swelling, and erythema.

Insertion site assessment of peripherally inserted central catheters: Inter-observer agreement between nurses and inpatients.

INTRODUCTION: Many patients are discharged from hospital with a peripherally inserted central catheter in place. Monitoring the peripherally inserted central catheter insertion site for clinical and research purposes is important for identifying complications, but the extent to which patients can reliably report the condition of their catheter insertion site is uncertain. The aim of this study was to assess the inter-observer agreement between nurses and patients when assessing a peripherally inserted central catheter site. METHODS: The study was based on inpatients who were enrolled in a single-centre, randomised controlled trial comparing four different dressing and securement devices for peripherally inserted central catheter sites. A seven-item peripherally inserted central catheter site assessment tool, containing questions about the condition of the dressing and the insertion site, was developed. Assessment was conducted once by the research nurse and, within a few minutes, independently by the patient. Proportions of agreement and Cohen's kappa were calculated. RESULTS: In total, 73 patients agreed to participate. Overall, percentage agreement ranged from 83% to 100% (kappa = .65-.82). For important clinical signs (redness, swelling, ooze, pus and tracking), there were high levels of percentage agreement (99%-100%). CONCLUSION: The high level of agreement between nurse/patient pairs make the instrument useful for assessing peripherally inserted central catheter-associated signs of localised infection, allergic or irritant dermatitis or dressing dislodgement in a community setting.

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.

Observational Study of Peripheral Intravenous Catheter Outcomes in Adult Hospitalized Patients: A Multivariable Analysis of Peripheral Intravenous Catheter Failure.

BACKGROUND: Almost 70% of hospitalized patients require a peripheral intravenous catheter (PIV), yet up to 69% of PIVs fail prior to completion of therapy. OBJECTIVE: To identify risk factors associated with PIV failure. DESIGN: A single center, prospective, cohort study. SETTING: Medical and surgical wards of a tertiary hospital located in Queensland, Australia. PARTICIPANTS: Adult patients requiring a PIV. MEASUREMENTS: Demographic, clinical, and potential PIV risk factors were collected. Failure occurred if the catheter had complications at removal. RESULTS: We recruited 1000 patients. Catheter failure occurred in 512 (32%) of 1578 PIVs. Occlusion/infiltration risk factors included intravenous (IV) flucloxacillin (hazard ratio [HR], 1.98; 95% confidence interval [CI], 1.19-3.31), 22-gauge PIVs (HR, 1.43; 95% CI, 1.02-2.00), and female patients (HR, 1.48; 95% CI, 1.10-2.00). Phlebitis was associated with female patients (HR, 1.81; 95% CI, 1.40-2.35), bruised insertion sites (HR, 2.16; 95% CI, 1.26-3.71), IV flucloxacillin (HR, 2.01; 95% CI, 1.26-3.21), and dominant side insertion (HR, 1.39; 95% CI, 1.09-1.77). Dislodgement risks were a paramedic insertion (HR, 1.78; 95% CI, 1.03-3.06).Each increase by 1 in the average number of daily PIV accesses was associated (HR 1.11, 95% CI 1.03-1.20)-(HR 1.14, 95% CI 1.08-1.21) with occlusion/infiltration, phlebitis and dislodgement. Additional securement products were associated with less (HR 0.32, 95% C-0.46)-(HR 0.63, 95% CI 0.48-0.82) occlusion/infiltration, phlebitis and dislodgement. CONCLUSION: Modifiable risk factors should inform education and inserter skill development to reduce the currently high rate of PIV failure.

The cost-effectiveness of a patient centred pressure ulcer prevention care bundle: Findings from the INTACT cluster randomised trial.

BACKGROUND: Pressure ulcers are serious, avoidable, costly and common adverse outcomes of healthcare. OBJECTIVES: To evaluate the cost-effectiveness of a patient-centred pressure ulcer prevention care bundle compared to standard care. DESIGN: Cost-effectiveness and cost-benefit analyses of pressure ulcer prevention performed from the health system perspective using data collected alongside a cluster-randomised trial. SETTINGS: Eight tertiary hospitals in Australia. PARTICIPANTS: Adult patients receiving either a patient-centred pressure ulcer prevention care bundle (n=799) or standard care (n=799). METHODS: Direct costs related to the intervention and preventative strategies were collected from trial data and supplemented by micro-costing data on patient turning and skin care from a 4-week substudy (n=317). The time horizon for the economic evaluation matched the trial duration, with the endpoint being diagnosis of a new pressure ulcer, hospital discharge/transfer or 28days; whichever occurred first. For the cost-effectiveness analysis, the primary outcome was the incremental costs of prevention per additional hospital acquired pressure ulcer case avoided, estimated using a two-stage cluster-adjusted non-parametric bootstrap method. The cost-benefit analysis estimated net monetary benefit, which considered both the costs of prevention and any difference in length of stay. All costs are reported in AU$(2015). RESULTS: The care bundle cost AU$144.91 (95%CI: $74.96 to $246.08) more per patient than standard care. The largest contributors to cost were clinical nurse time for repositioning and skin inspection. In the cost-effectiveness analysis, the care bundle was estimated to cost an additional $3296 (95%CI: dominant to $144,525) per pressure ulcer avoided. This estimate is highly uncertain. Length of stay was unexpectedly higher in the care bundle group. In a cost-benefit analysis which considered length of stay, the net monetary benefit for the care bundle was estimated to be -$2320 (95%CI -$3900, -$1175) per patient, suggesting the care bundle was not a cost-effective use of resources. CONCLUSIONS: A pressure ulcer prevention care bundle consisting of multicomponent nurse training and patient education may promote best practice nursing care but may not be cost-effective in preventing hospital acquired pressure ulcer.

Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial.

INTRODUCTION: Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. METHODS AND ANALYSIS: Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. SECONDARY OUTCOMES: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant. ETHICS AND DISSEMINATION: Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published. TRIAL REGISTRATION: Trial registration number is: ACTRN12616000315415.

Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial: A follow-up study.

BACKGROUND: Participation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care. OBJECTIVES: To describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care. METHODS: We conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage. RESULTS: A repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial's intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64-18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p=<0.001) and to be referred to an occupational therapist for protective devices (p=0.022). CONCLUSION: Participants in the intervention group of a clinical trial were more likely to receive additional post trial care and improved documentation compared with those in the control group but documentation of pressure ulcer status and care is poor.