Novel Peripheral Intravenous Catheter Securement for Children and Catheter Failure Reduction: A Randomized Clinical Trial.

Importance: Peripheral intravenous catheters (PIVCs) facilitate essential treatment. Failure of these essential devices is frequent and new securement strategies may reduce failure and improve patient outcomes. Objective: To evaluate clinical effectiveness of novel PIVC securement technologies for children to reduce catheter failure. Design, Setting, and Participants: A 3-arm, parallel group, superiority randomized clinical trial was conducted at 2 regional Australian hospitals from February 5, 2020, to January 14, 2022. Children aged 6 months to 8 years who were anticipated to require admission with a PIVC for at least 24 hours of in hospital treatment were eligible. Data were analyzed from May 25, 2022, to February 20, 2024. Interventions: Participants were randomly allocated in a 1:1:1 ratio to standard care, bordered polyurethane (Tegaderm [3M]), integrated securement dressing (SorbaView SHIELD [Medline]), and integrated securement dressing with tissue adhesive (Secureport IV). One catheter was studied per patient. Main Outcomes and Measures: Primary outcome was PIVC failure, defined as premature cessation of PIVC function for any reason prior to completion of planned treatment. Secondary outcomes were PIVC complications (any time dislodgement, occlusion, infiltration, partial dislodgement, extravasation, device leaking, phlebitis, pain), PIVC longevity, intervention acceptability (clinicians, participants, caregivers; 0-10 scale), and pain on removal (participants and caregivers; 0-10 scale relevant to age), adverse events, and health care costs. Results: A total of 383 patients (51% female; median age 36 [25th-75th percentiles, 22-72] months) were randomized 134 to standard care, 118 to integrated securement dressing, and 131 to integrated securement dressing with tissue adhesive. PIVC failure was lowest in integrated securement dressing with tissue adhesive (15 [12%]; adjusted hazard ratio [aHR], 0.47; 95% CI, 0.26-0.84) compared with integrated securement dressing (24 [21%]; aHR, 0.78; 95% CI, 0.47-1.28) and standard care (43 [34%]). Direct costs were significantly lower for integrated securement dressing with tissue adhesive (median, Australian dollars [A$], 312 [A$1 is equal to $0.65 US dollars]; IQR, A$302-A$380) and integrated securement dressing (median, A$303; IQR, A$294-A$465) compared with standard care (median, A$341; IQR, A$297-A$592; P ≤ .002) when considering the economic burden related to failure of devices. PIVC longevity and intervention acceptability were similar across all groups. Conclusions and Relevance: In this study, PIVCs secured with integrated securement dressings and tissue adhesive, in comparison with standard care, bordered polyurethane dressings, were associated with significantly reduced PIVC failure, for children admitted to hospital via the emergency department. Further research should focus on implementation in inpatient units where prolonged dwell and reliable intravenous access is most needed. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12619001026112.

The impact of a structured assessment and decision tool (I-DECIDED®) on improving care of peripheral intravenous catheters: A multicenter, interrupted time-series study.

BACKGROUND: Peripheral intravenous catheters are the most widely used invasive device in hospitals but have serious risks. OBJECTIVE: To determine if a structured assessment and decision tool (I-DECIDED®) improves daily peripheral intravenous catheter assessment and care decisions. DESIGN: Prospective, interrupted time-series study. SETTINGS: Seven adult inpatient wards in three Australian hospitals. PARTICIPANTS: 825 adults with 867 peripheral intravenous catheters. METHODS: Between August 2017 and December 2018, peripheral intravenous catheter assessments and chart audits were undertaken with informed patient consent. Following a 4-month pre-intervention period (with 2-weekly measures), the I-DECIDED® tool was implemented over 3 months (no data collection) using multiple strategies (stakeholder meetings, vascular access device form, education sessions, ward champions, lanyard cards, and posters), followed by a 4-month post-intervention period (with 2-weekly measures). Primary outcomes were device utilization (number of peripheral intravenous catheters per total number of patients screened); idle/unused catheters; insertion site complications, substandard dressing quality; and primary bloodstream infections. RESULTS: Of 2055 patients screened, 1175 (57.2%) had a peripheral intravenous catheter, and 825 patients (867 catheters) consented and were included in the final analysis. Device utilization increased from 42.0% of catheters at baseline to 49.6% post-intervention (absolute risk difference [ARD] 7.5%, 95% confidence interval [CI] 4.8, 10.3; relative risk [RR] 1.18, 95% CI 1.11, 1.25; p < 0.001). The proportion of idle catheters reduced from 12.7% to 8.3% (ARD -4.4%, 95% CI -8.5, -0.3; RR 0.66, 95% CI 0.44, 0.97; p = 0.035). Peripheral intravenous catheter complications reduced from 16.1% to 10.9% (ARD -5.2%, 95% CI -9.7, -0.6; RR 0.68, 95% CI 0.48, 0.96; p = 0.026). Substandard dressings reduced from 24.6% to 19.5% (ARD -5.2%, 95% CI -10.7, 0.4; RR 0.79, 95% CI 0.61, 1.02; p = 0.067). Only one primary bloodstream infection occurred (post-intervention). CONCLUSIONS: Implementation of a comprehensive device assessment and decision tool (I-DECIDED®) reduced idle catheters and catheter complications, despite higher device utilization. Dressing quality improved but was not statistically significant. Further implementation of the tool could improve hospital safety for patients with an intravenous catheter. ANZCTR TRIAL REGISTRATION: ACTRN12617000067370. Date of registration 13 January 2017. Date of first data collection 3rd August 2017. TWEETABLE ABSTRACT: #IDECIDEDassessment reduces prevalence of idle peripheral catheters and device complications.

Integrated versus nonintegrated peripheral intravenous catheter in hospitalized adults (OPTIMUM): A randomized controlled trial.

BACKGROUND: One-third of peripheral intravenous catheters (PIVCs) fail from inflammatory or infectious complications, causing substantial treatment interruption and replacement procedures. OBJECTIVES: We aimed to compare complications between integrated PIVCs (inbuilt extension sets, wings, and flattened bases) and traditional nonintegrated PIVCs. DESIGNS, SETTINGS AND PARTICIPANTS: A centrally randomized, controlled, superiority trial (with allocation concealment until study entry) was conducted in three Australian hospitals. Medical-surgical patients (one PIVC each) requiring intravenous therapy for >24 h were studied. MAIN OUTCOME MEASURES: The primary outcome was device failure (composite: occlusion, infiltration, phlebitis, dislodgement, local, or bloodstream infection). Infection endpoints were assessor-masked. The secondary outcomes were: failure type, first-time insertion success, tip colonization, insertion pain, dwell time, mortality, costs, health-related quality of life, clinician, and patient satisfaction. RESULTS: Out of 1759 patients randomized (integrated PIVC, n = 881; nonintegrated PIVC, n = 878), 1710 (97%) received a PIVC and were in the modified intention-to-treat analysis (2269 PIVC-days integrated; 2073 PIVC-days nonintegrated). Device failure incidence was 35% (145 per 1000 device-days) nonintegrated, and 33% (124 per 1000 device-days) integrated PIVCs. INTERVENTION: Integrated PIVCs had a significantly lower failure risk (adjusted [sex, infection, setting, site, gauge] hazard ratio [HR]: 0.82 [95% confidence interval, CI: 0.69-0.96], p = .015). The per-protocol analysis was consistent (adjusted HR: 0.80 [95% CI: 0.68-0.95], p = .010). Integrated PIVCs had significantly longer dwell (top quartile ≥ 95 vs. ≥84 h). Mean per-patient costs were not statistically different. CONCLUSIONS: PIVC failure is common and complex. Significant risk factors include sex, infection at baseline, care setting, insertion site, catheter gauge, and catheter type. Integrated PIVCs can significantly reduce the burden of PIVC failure on patients and the health system.

The Cost Consequences of the Gold Coast Integrated Care Programme.

INTRODUCTION: The Australian Gold Coast Integrated Care programme trialled a model of care targeting those with chronic and complex conditions at highest risk of hospitalisation with the goal of producing the best patient outcomes at no additional cost to the healthcare system. This paper reports the economic findings of the trial. METHODS: A pragmatic non-randomised controlled study assessed differences between patients enrolled in the programme (intervention group) and patients who received usual care (control group), in health service utilisation, including Medicare Benefits Schedule and Pharmaceutical Benefits Scheme claims, patient-reported outcome measures, including health-related quality of life, mortality risk, and cost. RESULTS: A total of 1,549 intervention participants were enrolled and matched on the basis of patient level data to 3,042 controls. We found no difference in quality of life between groups, but a greater decrease in capability, social support and satisfaction with care scores and higher hospital service use for the intervention group, leading to a greater cost to the healthcare system of AUD$6,400 per person per year. In addition, the per person per year cost of being in the GCIC programme was AUD$8,700 equating to total healthcare expenditures of AUD$15,100 more for the intervention group than the control group. CONCLUSION: The GCIC programme did not show value for money, incurring additional costs to the health system and demonstrating no significant improvements in health-related quality of life. Because patient recruitment was gradual throughout the trial, we had only one year of complete data for analysis which may be too short a period to determine the true cost-consequences of the program.

A web-based mental health promotion intervention for pharmacy staff to reduce stigmatising and discriminating attitudes.

ISSUE ADDRESSED: Stigma and discrimination can have a significant impact on successful mental health recovery. This research evaluated the effectiveness of a web-based mental health promotion intervention on stigma and discrimination in community pharmacies via assessment of staff attitudes, confidence and skills. METHODS: Guided by the intervention mapping framework, we used experiential learning techniques, including pre-recorded consumer/carer narratives, role-plays and panel discussions accessed by participants in an innovative, flexible, web-based, program of modules. A quasi-experimental pre-post design was used to evaluate the intervention effectiveness. Participants completed pre- (T1) and post-intervention (T2) questionnaires that contained both validated measures and questions developed or adapted specifically for this evaluation. RESULTS: 566 pharmacy staff (357 pharmacists, 209 support staff) completed the intervention between September 2012 and May 2013; pharmacists completed eight online modules (4-hours total), support staff completed four (2-hours total). After participating, staff attitudes about mental health had changed in a positive direction; their confidence and skills when working with consumers and their carers had increased overall, although support staff remained less confident than pharmacists. CONCLUSION: These results suggest that the involvement of consumers and carers in the intervention development and delivery was integral to reducing pharmacy staff stigma and enhancing confidence and communication skills.

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.

Integrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): a randomised controlled trial protocol.

INTRODUCTION: Peripheral intravenous catheters (PIVCs) are frequently used in hospitals. However, PIVC complications are common, with failures leading to treatment delays, additional procedures, patient pain and discomfort, increased clinician workload and substantially increased healthcare costs. Recent evidence suggests integrated PIVC systems may be more effective than traditional non-integrated PIVC systems in reducing phlebitis, infiltration and costs and increasing functional dwell time. The study aim is to determine the efficacy, cost-utility and acceptability to patients and professionals of an integrated PIVC system compared with a non-integrated PIVC system. METHODS AND ANALYSIS: Two-arm, multicentre, randomised controlled superiority trial of integrated versus non-integrated PIVC systems to compare effectiveness on clinical and economic outcomes. Recruitment of 1560 patients over 2 years, with randomisation by a centralised service ensuring allocation concealment. Primary outcomes: catheter failure (composite endpoint) for reasons of: occlusion, infiltration/extravasation, phlebitis/thrombophlebitis, dislodgement, localised or catheter-associated bloodstream infections. SECONDARY OUTCOMES: first time insertion success, types of PIVC failure, device colonisation, insertion pain, functional dwell time, adverse events, mortality, cost-utility and consumer acceptability. One PIVC per patient will be included, with intention-to-treat analysis. Baseline group comparisons will be made for potentially clinically important confounders. The proportional hazards assumption will be checked, and Cox regression will test the effect of group, patient, device and clinical variables on failure. An as-treated analysis will assess the effect of protocol violations. Kaplan-Meier survival curves with log-rank tests will compare failure by group over time. Secondary endpoints will be compared between groups using parametric/non-parametric techniques. ETHICS AND DISSEMINATION: Ethical approval from the Royal Brisbane and Women's Hospital Human Research Ethics Committee (HREC/16/QRBW/527), Griffith University Human Research Ethics Committee (Ref No. 2017/002) and the South Metropolitan Health Services Human Research Ethics Committee (Ref No. 2016-239). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12617000089336.

Effects of telemonitoring on glycaemic control and healthcare costs in type 2 diabetes: A randomised controlled trial.

Introduction This study examined the effect of a telehealth intervention on the control of type 2 diabetes and subsequent potential cost-savings to the health system. Methods This prospective randomised controlled trial randomised adults with type 2 diabetes to the intervention (diabetes program) or control (usual care) arm. Key eligibility criteria included an HbA1c level of at least 58 mmol/mol (7.5%) without severe or unstable comorbidities. All participants continued their usual healthcare, but participants in the intervention arm received additional diabetes care from a diabetes care coordinator via a home monitor that captured clinical measures. Data collected included biomedical, quality of life measures and healthcare (GP, outpatient and inpatient) costs. The primary outcome was HbA1c collected at baseline and 6 months. Analysis was conducted on a complete case intention-to-treat basis. The healthcare system perspective was taken to calculate the incremental cost per percentage-point reduction in HbA1c. Results Results from 63 participants from each study arm were analysed. HbA1c in the intervention group decreased from a median 68 mmol/mol (8.4%) to 58 mmol/mol (7.5%), and remained unchanged in the control group at median 65 mmol/mol (8.1%) at the 6-month endpoint. The intervention effect on HbA1c change was statistically significant ( p = .004). Total healthcare costs in the intervention group, including the intervention costs, were lower (mean $3781 vs. $4662; p < .001) compared with usual care. Discussion There was a clinically meaningful and statistically significant benefit from the telehealth intervention at a lower cost; thus, telehealth was cost-saving and produced greater health benefits compared with usual care.

Reduced employment and financial hardship among middle-aged individuals with colorectal cancer.

Financial hardship may affect up to 30% of cancer survivors, however, little research has addressed the effect of employment change on financial hardship. This study compared the self-reported financial hardship of middle-aged (45-64 years) colorectal cancer survivors (n = 187) at 6 and 12 months following diagnosis with that of a matched general population group (n = 355). Colorectal cancer survivors were recruited through the Queensland Cancer Registry, Australia; data from the Household Income and Labour Dynamics in Australia (HILDA) Survey were used for the general population group. Pearson chi-square tests were used to assess the differences in proportions between the two groups and McNemar tests to assess differences across time among the same group. Generalised linear modelling was performed to produce prevalence ratios. A higher proportion of workers with colorectal cancer reported financial strain (money shortage for living essentials) at 6 months (15%) but eased and was comparable to the comparison group at 12 months (7%). Middle-aged working cancer survivors who ceased or reduced work were more likely to report not being financially comfortable, compared with those who had continued work (adjusted prevalence ratio 1.66, 95%CI: 1.12, 2.44) at 12 months. Health professionals, employers and government services should address the impact of impaired employment on financial hardship among cancer survivors.

Evaluation of the Gold Coast Integrated Care for patients with chronic disease or high risk of hospitalisation through a non-randomised controlled clinical trial: a pilot study protocol.

INTRODUCTION: Chronic diseases are the leading cause of illness, disability and death in Australia. The prevalence and associated health expenditure are projected to soar. There is no 'whole system' approach to healthcare in Australia. To overcome this fragmentation, the Gold Coast Hospital and Health Service (GCHHS) is developing a new model known as Gold Coast Integrated Care (GCIC). To evaluate GCIC a 4-year pilot trial commenced in March 2015. This protocol paper describes the evaluation of GCIC. METHODS AND ANALYSIS: A pragmatic non-randomised controlled clinical trial is conducted to test the hypothesis that GCIC will result in improved health and well-being at no additional cost to the healthcare system. Using a mixed methods approach, impact, outcome and process evaluations will be undertaken to assess the effectiveness and acceptability, including the balance of costs between primary and public secondary care sectors, staff and training requirements, clinical service delivery, and trial implementation.Fifteen general practices have agreed to deliver GCIC. One thousand five hundred of their adult patients with treated chronic diseases, high risk of hospitalisation or healthcare utilisation were recruited to the intervention arm. Approximately 3000 patients not associated with the participating general practices were identified as controls using propensity matching which will provide service utilisation and disease data for usual care.Baseline data and follow-up observations are collected annually until the end of 2018. Quantitative analyses will measure patient healthcare costs, utilisation of health services, and health outcomes, and general practice clinical service delivery according to clinical guidelines (number of foot exams, HbA1c tests). Qualitative analyses will focus on patient and staff experiences, satisfaction, engagement and implementation of the programme as planned. ETHICS AND DISSEMINATION: Approval was received from the GCHHS and Griffith University. The study is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000821493). Findings will be communicated via yearly reports to funding bodies and scientific publications. TRIAL REGISTRATION NUMBER: ACTRN12616000821493; Pre-results.

The cost-effectiveness of a web-based multimodal therapy for unilateral cerebral palsy: the Mitii randomized controlled trial.

AIM: To estimate the cost-effectiveness of the Mitii training system for improvements in upper limb function for children with unilateral cerebral palsy (CP). Mitii is a web-based programme delivered at home with set-up and monitoring by therapists. METHOD: A randomized controlled trial was conducted comparing the Mitii training programme to usual care. The Assessment of Motor and Process Skills (AMPS) and Canadian Occupational Performance Measure (COPM) were collected for each child at baseline and 20 weeks. Responders to training were characterized as those who met a minimally important difference on either the AMPS (0.3 logits) or COPM (2 points). Costs of the intervention were calculated by quantifying the equipment and staff cost. A cost per responder was calculated for each of the outcome measures. RESULTS: A total of 102 participants (52 males, 50 females) were included in the analysis. There were significantly more responders in the training group on both the AMPS motor and process scales and the COPM performance and satisfaction scales. The cost per responder for the Mitii programme ranged from AU$3078 to AU$4191 depending on the scale used. INTERPRETATION: The cost of delivering the Mitii training system is modest relative to the improvements in function.

An economic evaluation alongside a randomised controlled trial on psycho-education counselling intervention offered by midwives to address women's fear of childbirth in Australia.

OBJECTIVE: The rate of caesarean section continues to increase, and there is evidence that childbirth fear is a contributing factor. Insufficient evidence is available on the impact of reducing childbirth fear on health-related quality of life and health service use. We undertook an economic evaluation of a psycho-education counselling intervention offered by midwives to address women's fear of childbirth in Australia. METHODS: Pregnant women (n = 339) with high childbirth fear were randomised to a midwife-led psycho-education intervention for childbirth fear or to usual care. This paper presents the economic evaluation of the intervention based on health-related quality of life and health service use from recruitment to six weeks postpartum (n = 184). RESULTS: The changes in health-related quality of life after birth (EQ-5D-3L: 0.016 vs. 0.010, p = 0.833, for usual care and intervention) and total health care use cost (AUS$10,110 vs. AUS$9980, p = 0.819) were similar between groups. The intervention did not increase costs; however, in a post hoc analysis, the interventions might be cost-effective for those women with very high childbirth fear. CONCLUSION: This brief psycho-education intervention by midwives did not improve the health-related quality of life of women, and had no impact on overall cost.

Dressing and securement for central venous access devices (CVADs): A Cochrane systematic review.

OBJECTIVES: To compare the available dressing and securement devices for central venous access devices (CVADs). DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Cochrane Wounds Group Specialised Register, the Cochrane Central Register of Controlled Trials, the Database of Abstracts of Reviews and of Effects, NHS Economic Evaluation Database, Ovid MEDLINE, CINAHL, EMBASE, clinical trial registries and reference lists of identified trials. REVIEW METHODS: Studies evaluated the effects of dressing and securement devices for CVADs. All types of CVADs were included. Outcome measures were CVAD-related bloodstream infection, CVAD tip colonisation, entry and exit site infection, skin colonisation, skin irritation, failed CVAD securement, dressing condition and mortality. We used standard methodological approaches as expected by The Cochrane Collaboration. RESULTS: We included 22 studies involving 7436 participants comparing nine different types of securement device or dressing. All included studies were at unclear or high risk of performance bias due to the different appearances of the dressings and securement devices. It is unclear whether there is a difference in the rate of CVAD-related bloodstream infection between securement with gauze and tape and standard polyurethane (RR 0.64, 95% CI 0.26 to 1.63, low quality evidence), or between chlorhexidine gluconate-impregnated dressings and standard polyurethane (RR 0.65, 95% CI 0.40 to 1.05, moderate quality evidence). There is high quality evidence that medication-impregnated dressings reduce the incidence of CVAD-related bloodstream infection relative to all other dressing types (RR 0.60, 95% CI 0.39 to 0.93). There is moderate quality evidence that chlorhexidine gluconate-impregnated dressings reduce the frequency of CVAD-related bloodstream infection per 1000 patient days compared with standard polyurethane dressings (RR 0.51, 95% CI 0.33 to 0.78). There is moderate quality evidence that catheter tip colonisation is reduced with chlorhexidine gluconate-impregnated dressings compared with standard polyurethane dressings (RR 0.58, 95% CI 0.47 to 0.73), but the relative effects of gauze and tape and standard polyurethane are unclear (RR 0.95, 95% CI 0.51 to 1.77, very low quality evidence). CONCLUSIONS: Medication-impregnated dressing products reduce the incidence of CVAD-related bloodstream infection relative to all other dressing types. There is some evidence that chlorhexidine gluconate-impregnated dressings, relative to standard polyurethane dressings, reduce CVAD-related bloodstream infection for the outcomes of frequency of infection per 1000 patient days, risk of catheter tip colonisation and possibly risk of CVAD-related bloodstream infection. Most studies were conducted in intensive care unit settings. More, high quality research is needed regarding the relative effects of dressing and securement products for CVADs.

Protocol for assessing maternal, environmental and epigenetic risk factors for dental caries in children.

BACKGROUND: Expenditure on dental and oral health services in Australia is $3.4 billion AUD annually. This is the sixth highest health cost and accounts for 7 % of total national health expenditure. Approximately 49 % of Australian children aged 6 years have caries experience in their deciduous teeth and this is rising. The aetiology of dental caries involves a complex interplay of individual, behavioural, social, economic, political and environmental conditions, and there is increasing interest in genetic predisposition and epigenetic modification. METHODS: The Oral Health Sub-study; a cross sectional study of a birth cohort began in November 2012 by examining mothers and their children who were six years old by the time of initiation of the study, which is ongoing. Data from detailed questionnaires of families from birth onwards and data on mothers' knowledge, attitudes and practices towards oral health collected at the time of clinical examination are used. Subjects' height, weight and mid-waist circumference are taken and Body Mass Index (BMI) computed, using an electronic Bio-Impedance balance. Dental caries experience is scored using the International Caries Detection and Assessment System (ICDAS). Saliva is collected for physiological measures. Salivary Deoxyribose Nucleic Acid (DNA) is extracted for genetic studies including epigenetics using the SeqCap Epi Enrichment Kit. Targets of interest are being confirmed by pyrosequencing to identify potential epigenetic markers of caries risk. DISCUSSION: This study will examine a wide range of potential determinants for childhood dental caries and evaluate inter-relationships amongst them. The findings will provide an evidence base to plan and implement improved preventive strategies.

Dressings and securement devices for central venous catheters (CVC).

BACKGROUND: Central venous catheters (CVCs) play a vital role in the management of acute and chronic illness. Dressings and securement devices must ensure CVCs do not dislodge or fall out, provide a barrier protection from microbial colonisation and infection, and be comfortable for the patient. There is a large range of dressing and securement products available for clinicians to use. OBJECTIVES: To compare the available dressing and securement devices for CVCs, in terms of catheter-related bloodstream infection (BSI), catheter colonisation, entry- and exit-site infection, skin colonisation, skin irritation, failed catheter securement, dressing condition and mortality. SEARCH METHODS: In June 2015 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); The Database of Abstracts of Reviews of Effects (DARE); NHS Economic Evaluation Database (NHSEED); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; six clinical trial registries and reference lists of identified trials. There were no restrictions based on language or date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials that evaluated the effects of dressing and securement devices for CVCs. All types of CVCs were included, i.e. short- and long-term CVCs, tunnelled and non-tunnelled, port-a-caths, haemodialysis catheters, and peripherally-inserted central catheters (PICCs). DATA COLLECTION AND ANALYSIS: We used standard Cochrane Collaboration methods including independent review of titles and abstracts for relevance, data extraction, and risk of bias assessment of the included studies by two review authors. Results are expressed using risk ratio (RR) for categorical data with 95% confidence intervals (CIs). For outcomes best presented as a rate-per-time-period, rate ratios and standard errors have been used. We performed multiple treatment meta-analyses to rank the effectiveness of each intervention for each outcome. MAIN RESULTS: We included 22 studies involving 7436 participants comparing nine different types of securement device or dressing. All included studies were at unclear or high risk of performance bias due to the different appearances of the dressings and securement devices. The extent of blinding of outcome assessment was unclear in most studies. The quality of evidence varied between different comparisons and outcomes. We mainly downgraded the quality of evidence for imprecision, indirectness, risk of bias and inconsistency.It is unclear whether there is a difference in the rate of catheter-related BSI between securement with gauze and tape and standard polyurethane (SPU) (RR 0.64, 95% CI 0.26 to 1.63, low quality evidence), or between chlorhexidine gluconate-impregnated (CGI) dressings and SPU (RR 0.65, 95% CI 0.40 to 1.05, moderate quality evidence). There is high quality evidence that medication-impregnated dressings reduce the incidence of catheter-related BSI relative to all other dressing types (RR 0.60, 95% CI 0.39 to 0.93).There is moderate quality evidence that CGI dressings reduce the frequency of catheter-related BSI per 1000 patient days compared with SPU dressings (RR 0.51, 95% CI 0.33 to 0.78).There is moderate quality evidence that catheter tip colonisation is reduced with CGI dressings compared with SPU dressings (RR 0.58, 95% CI 0.47 to 0.73), but the relative effects of gauze and tape and SPU are unclear (RR 0.95, 95% CI 0.51 to 1.77, very low quality evidence). It is unclear if there is a difference in rates of skin irritation or damage when CGI dressings are compared with SPU dressings (moderate quality evidence) (RR 11.17, 95% CI 0.84 to 149.48).A multiple treatment meta-analysis found sutureless securement devices as likely to be the most effective at reducing the incidence of catheter-related BSI (low quality evidence), with CGI dressings ranked second (low quality evidence). AUTHORS' CONCLUSIONS: Medication-impregnated dressing products reduce the incidence of catheter-related BSI relative to all other dressing types. There is some evidence that CGI dressings, relative to SPU dressings, reduce catheter-related BSI for the outcomes of frequency of infection per 1000 patient days, risk of catheter tip colonisation and possibly risk of catheter-related BSI. A multiple treatment meta-analysis found that sutureless securement devices are likely to be the most effective at reducing catheter-related BSI though this is low quality evidence. Most studies were conducted in intensive care unit (ICU) settings. More, high quality research is needed regarding the relative effects of dressing and securement products for CVCs. Future research may adjust the estimates of effect for the products included in this review and is needed to assess the effectiveness of new products.

A pilot trial of bordered polyurethane dressings, tissue adhesive and sutureless devices compared with standard polyurethane dressings for securing short-term arterial catheters.

OBJECTIVES: To improve arterial catheter (AC) securement and reduce AC failure; to assess feasibility of a large randomised controlled trial. DESIGN, SETTING AND PARTICIPANTS: A four-arm, parallel, randomised, controlled, non-blinded pilot trial with 195 intensive care patients taking part, in a tertiary referral hospital in Brisbane, Australia from May to November 2012. INTERVENTIONS: Standard polyurethane (SPU) dressing (controls); bordered polyurethane (BPU) + SPU dressing; tissue adhesive (TA) + SPU dressing; and sutureless securement device (SSD) + SPU dressing (no sutures used). MAIN OUTCOME MEASURES: AC failure, ie, complete dislodgement, occlusion (monitor failure, inability to infuse or fluid leaking), pain or infection (local or blood). RESULTS: Median AC dwell time was 26.2 hours and was comparable between groups. AC failure occurred in 26/195 patients (13%). AC failure was significantly worse with SPU dressings (10/47 [21%]) than with BPU + SPU dressings (2/ 43 [5%]; P = 0.03), but not significantly different to TA + SPU (6/56 [11%]; P = 0.18) or SSD + SPU (8/49 [16%]; P = 0.61). The dressing applied at AC insertion lasted until AC removal in 68% of controls; 56% of BPU + SPU dressings; 73% of TA + SPU dressings; and 80% of SSD + SPU dressings (all P > 0.05). There were no infections or serious adverse events. Patient and staff satisfaction with all products was high. Median costs (labour and materials) for securement per patient were significantly higher in all groups compared with the control group (SPU, $3.48 [IQR, $3.48-$9.79]; BPU + SPU, $5.07 [IQR, $5.07-$12.99]; SSD + SPU, $10.90 [IQR, $10.90-$10.90]; TA + SPU, $17.70 [IQR, $17.70-$38.36]; all P < 0.01). CONCLUSION: AC failure occurred significantly less often with BPU + SPU dressings than with SPU dressings. TA + SPU and SSD + SPU dressings should be further investigated and compared with BPU + SPU dressings as controls. The novel approach of TA + SPU dressings appeared safe and feasible.