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Background Health-related quality of life (HRQoL) of patients, aged 75 years or older, was measured before and at 12 weeks after cardiac surgery using a generic tool (SF12 version 2). Methods This was a single centre, prospective study of patients aged 75 years or older who had any type of cardiac surgery. The instrument was self-administered preoperatively and by interviewer administered via telephone at 12 weeks. Results Sixty-six (66) of the 81 participants approached were eligible and agreed to participate. Mean age was 79.2 years, 17 participants were female (25.8%), 56 participants were New Zealand European (84.8%) and the mean Euroscore II score was 4.0. Sixty (60) participants (90.9%) provided data at follow-up. All mean HRQoL domain scores significantly improved by 12 weeks after surgery. The pattern of gain was similar for ages 75–79 and 80 years and older. The changes in the physical and mental component summary (PCS, MCS) scores were statistically significant and the mean scores were proximate to or better than age group norms at 12 weeks. The number of patients with a PCS score at or above age group norms improved from 16.4% to 56.6% while the number of patients whose MCS scores were at or above age group norms improved from 55.7% to 81.6%. Health utility values also significantly improved. Conclusions Cardiac surgery in older patients is associated with significantly improved physical and mental health-related quality of life at 12 weeks after procedure.

Background Despite the evidence and available guidelines about endotracheal suction (ETS), a discrepancy between published guidelines and clinical practice persists. To date, ETS practice in the adult intensive care unit (ICU) population across New Zealand and Australia has not been described. Objective To describe ICU nurses' ETS practice in New Zealand and Australia including the triggers for performing endotracheal suction. Methods A single day, prospective observational, binational, multicentre point prevalence study in New Zealand and Australian ICUs. All adult patients admitted at 10:00 on the study day were included. Main outcome measures In addition to patient demographic data, we assessed triggers for ETS, suction canister pressures, use of preoxygenation, measures of oxygenation, and ETS at extubation. Results There were 682 patients in the ICUs on the study day, and 230 were included in the study. Three of 230 patients were excluded for missing data. A total of 1891 ETS events were performed on 227 patients during the study day, a mean of eight interventions per patient. The main triggers reported were audible (n = 385, 63%) and visible (n = 239, 39%) secretions. Less frequent triggers included following auscultation (n = 142, 23%), reduced oxygen saturations (n = 140, 22%), and ventilator waveforms (n = 53, 9%). Mean suction canister pressure was −337 mmHg (standard deviation = 189), 67% of patients received preoxygenation (n = 413), and ETS at extubation was performed by 84% of nurses. Conclusion Some practices were inconsistent with international guidelines, in particular concerning patient assessment for ETS and suction canister pressure.

IntroductionCompression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise.Methods and analysisThe Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective.Ethics and disseminationThe Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numbersAustralia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).

BACKGROUND There is a growing body of evidence addressing the patient experience of intensive care, including patient reports that the presence of an endotracheal tube is bothersome and distressing, and that endotracheal suction is moderately to extremely painful. Yet there remains little information about the patient experience of the endotracheal tube and suction in those patients receiving planned short-term mechanical ventilation. AIMS AND OBJECTIVES This study aimed to describe the patient experience of the endotracheal tube and suction, following mechanical ventilation in post-operative cardiac surgical patients. DESIGN This qualitative study used inductive thematic analysis. Participants having planned cardiac surgery, anticipated to receive less than 12-hours mechanical ventilation, were approached pre-operatively and written consent provided. METHODS Ten participants were recruited using purposive sampling. Semi-structured interviews were conducted between days four and six post-operatively. One researcher interviewed all participants; two researchers independently read, coded, and agreed themes. FINDINGS None of the participants recalled endotracheal suction, while half had no recollection of the endotracheal tube. Three themes were identified; the experience of the endotracheal tube and extubation, the experience of emerging from sedation, and participants concerns about the future. The presence of the endotracheal tube was described as bothersome, whilst breathing through the tube and extubation were described as 'weird' and 'strange' but not painful. CONCLUSIONS Knowledge of the patient experience can help inform nursing practice by improving pre and post-operative care planning. RELEVANCE TO CLINICAL PRACTICE This study adds to the body of knowledge about the patient experience of the endotracheal tube and extubation. TRIAL REGISTRATION Prospective registration with the Australian New Zealand Clinical Trials Registry. www.anzctr.org.au (ACTRN12616001515482).

Understanding the key determinants of health from a community perspective is essential to address and improve the health and wellbeing of its members. This qualitative study aimed to explore and better understand New Zealand-based Pasifika communities’ sociocultural experiences and knowledge of health and wellbeing. Fifty-seven participants were involved in six separate focus groups. Community coordinators co-facilitated and transcribed the discussions and conducted thematic analysis. The findings suggested two overarching themes: (1) ‘Pasifika experiences on poor health and well-being’: were based on sub-themes: (i) ‘recognisable issues’ (e.g., poor diet and lifestyle behaviours); (ii) ‘systemic issues’ that support the perpetual health issues (e.g., lack of knowledge and education) and; (iii) ‘profound issues’ that are often unspoken of and create long-term barriers (e.g., cultural lifestyle and responsibilities). (2) ‘Hopes and dreams’ to improve health and well-being requires: (i) a family-centric approach to health; (ii) tackling systemic barriers; and (iii) addressing community social justice issues. This study provides deepened insights on Pasifika communities’ understanding healthier living in the context of their cultural environment and family responsibilities. If we are to develop effective, sustainable programmes that prioritises health and well-being based on the needs of Pasifika communities, the findings from this study highlight their needs as step forward in overcoming barriers to healthier lives.

The obesity rate in New Zealand is one of the highest worldwide (31%), with highest rates among Māori (47%) and Pasifika (67%). Codesign was used to develop a culturally tailored, behavior change mHealth intervention for Māori and Pasifika in New Zealand. The purpose of this article is to provide an overview of the codesign methods and processes and describe how these were used to inform and build a theory-driven approach to the selection of behavioral determinants and change techniques. The codesign approach in this study was based on a partnership between Māori and Pasifika partners and an academic research team. This involved working with communities on opportunity identification, elucidation of needs and desires, knowledge generation, envisaging the mHealth tool, and prototype testing. Models of Māori and Pasifika holistic well-being and health promotion were the basis for identifying key content modules and were applied to relevant determinants of behavior change and theoretically based behavior change techniques from the Theoretical Domains Framework and Behavior Change Taxonomy, respectively. Three key content modules were identified: physical activity, family/whānau [extended family], and healthy eating. Other important themes included mental well-being/stress, connecting, motivation/support, and health literacy. Relevant behavioral determinants were selected, and 17 change techniques were mapped to these determinants. Community partners established that a smartphone app was the optimal vehicle for the intervention. Both Māori and Pasifika versions of the app were developed to ensure features and functionalities were culturally tailored and appealing to users. Codesign enabled and empowered users to tailor the intervention to their cultural needs. By using codesign and applying both ethnic-specific and Western theoretical frameworks of health and behavior change, the mHealth intervention is both evidence based and culturally tailored.

ObjectiveTo determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.DesignPragmatic parallel group randomised controlled trial.SettingCommunity-dwelling participants.ParticipantsPeople aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both).InterventionWool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.Primary and secondary outcome measuresHealing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.ResultsWe screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference −6.4%, 95% CI −22.5% to 9.7%), change in ulcer area (−1.9 cm2, 95% CI −16.5 to 12.8 cm2), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI −12.4% to 24.9%).ConclusionThe effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.Trial registration numberNCT02896725

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: The OL@-OR@ mobile health programme was co-designed with Māori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Māori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. Methods: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Māori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. Findings: Between Jan 24 and Aug 14, 2018, we enrolled 337 Māori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Māori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Māori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Māori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84–1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73–1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67–1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37–1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79–1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). Interpretation: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Māori and Pasifika individuals. Funding: Healthier Lives He Oranga Hauora National Science Challenge.

Venous insufficiency is the most common cause of leg ulceration, but the impact of venous leg ulceration on health-related quality of life has not been adequately assessed. This study compared data from randomized controlled trials to population norms obtained from a large national population survey. We combined the baseline Short Form-36 (SF-36) version 1 data from two New Zealand randomized controlled trials that recruited participants with VLU and compared the pooled data to the population scores obtained from the New Zealand Health Survey using general linear regression to adjust for age, sex, and ethnicity differences between the cohorts. Baseline SF-36 scores obtained from 618 trial participants were compared to the SF-36 scores obtained from the 12,529 participants in the New Zealand Health Survey. Participants with VLU had significantly lower crude SF-36 scores across all eight SF-36 domains, but there was interaction between age and group. Adjusted mean differences for participants aged 65 years or younger were -25.8, -32.1, -21.2, -9.6, -7.6, -23.9, -21.5, and -9.3, respectively, for Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health whereas the adjusted mean differences for older participants were -15.7, -23.8, -13.8, -0.3 (nonsignificant), -4.6, -15.3, -21.2, and -6.6. This study is the first to compare a VLU population to norms from a general population survey and the first to show VLU interacts with age creating stronger impact in younger patients compared their age cohort. Younger patients may have need of more pastoral care as a consequence.

Introduction: There is growing concern that Emergency Departments (ED) are ill equipped to manage rising palliative care demand, but actual demand is unknown. The aim of this study was to estimate the annual incidence of patients with palliative care need presenting to EDs.Methods: Retrospective case review study across two New Zealand emergency departments from 1 July 2010 to 30 June 2011. We used a two-step process where (1) administrative databases were screened for patients who had presented with 12 diseases associated with palliative care need and (2) the Gold Standard Framework Prognostic Indicator Guidance (GSF PIG) criteria were applied to the clinical records of a random sample of patients meeting the disease criterion.Results: Fifty-three thousand and fifty-seven patients presented to the EDs; 4488 (8.5%) patients had diagnostic codes indicating potential palliative care need and 1024 were randomly sampled. One hundred and eighty-eight patients (18.4%, 95%CI 16.0–20.8%) from the random sample we...

Aim To be in accord with the Consolidated Standards of Reporting Trials (CONSORT) Statement, all important adverse events in randomised controlled trials (RCTs) should be reported, as well as trial registration. Neither concern has been investigated in venous leg ulcer trials. We therefore aimed to quantify and explore compliance with adverse event reporting and trials registration in RCTs that reported interventions for treating venous leg ulceration. Materials and methods We searched the Cochrane Controlled Trials Register, Medline, Embase, and CINAHL for studies reported between 2001 and 2017. Included studies must have been described as randomised controlled trials evaluating any intervention in a VLU population. Data was then extracted by one author into a standard form and checked by a second author. Results We screened 3100 titles and identified 204 trials involving pharmaceuticals (82), medicated and non-medicated devices (102), organisational (5) or other interventions (15) published in 76 journals. Eighty-four trials reported adverse events (41.2%), while 18 reported no events occurred (8.8%) and 78 did not report adverse events (38.2%). Types of adverse events reported included all-cause (20.1%), ulcer-related only (38.2%), treatment-related only (11.3%) and serious adverse events only (1.0%). Only 38 trials were registered (18.6%). Trial registration was associated with reporting of any adverse events (Odds Ratio 3.0, 95%CI 1.1–7.9), as was the trial being a pharmaceutical trial (Odds Ratio 2.9, 95%CI 1.5–5.7) or a multicentre trial (Odds Ratio 4.2, 95%CI 2.2–8.1). Conclusion Adverse event reporting in VLU trials is variable with about one third of trials not reporting on adverse events at all. Trials registration is a the modifiable factor associated with better reporting of adverse events. Journal editors could explore how they can promote trials registration to enhance better reporting of harms in VLU trials.

Background Healthy lifestyle programs that are designed specifically to appeal to and support men to improve lifestyle behaviors and lose weight are needed. The Rugby Fans in Training-New Zealand (RUFIT-NZ) program is delivered by professional rugby clubs and inspired by the successful Football Fans In Training program (FFIT), a gender sensitized weight loss program for obese middle-aged men delivered by professional football clubs in Scotland. RUFIT-NZ required development and evaluation for feasibility. Methods To develop the intervention we reviewed content from the FFIT program and evidence-based physical activity, dietary and weight management guidelines, and undertook a series of focus groups and key informant interviews. We then evaluated the feasibility of the intervention in a two-arm, parallel, pilot randomized controlled trial in New Zealand. Ninety-six participants were randomized to either the 12-week RUFIT-NZ intervention (N = 49) or a control group (N = 47). The intervention was delivered through professional rugby clubs and involved physical activity training and classroom sessions on healthy lifestyle behaviors. Pilot trial outcomes included body weight, heart rate, blood pressure, cardiorespiratory fitness, and lifestyle behaviors. Feasibility was assessed by recruitment and retention rates, and acceptability of the intervention. Results At 12 weeks the mean difference in body weight was 2.5 kg (95% CI -0.4 to 5.4), which favored the intervention. Statistically significant differences in favor of the intervention group were also observed for waist circumference, resting heart rate, diastolic blood pressure, cardiorespiratory fitness, and the proportion of participants that were adherent to 3 or more healthy lifestyle behaviors. The intervention was considered feasible to test in a full trial given the good recruitment and retention rates, and positive feedback from participants. Conclusions A pilot study of a healthy lifestyle intervention delivered via professional rugby clubs in New Zealand demonstrated positive effects on weight and physiological outcomes, as well as adherence to lifestyle behaviors. Feasibility issues in terms of recruitment, retention, and participant acceptability were assessed and findings will be used to inform the design of a definitive trial. Trial registration The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12616000137493, 05/12/2016.

Most mobile health (mHealth) programmes are designed with minimal input from target end users and are not truly personalised or adaptive to their specific and evolving needs. This review describes the methods and processes used in the co-design of mHealth interventions. Nine relevant studies of varying design were identified following searches of six academic databases. All employed co-design or participatory methods for the development of a health intervention delivered via a mobile device, with three focusing on health behaviour change (one on nutrition) and six on management of a health condition. Overall, six key phases of design and 17 different methods were used. Sufficiency of reporting was poor, and no study undertook a robust assessment of efficacy; these factors should be a focus for future studies. An opportunity exists to use co-design methods to develop acceptable and feasible mHealth interventions, especially to support improved nutrition and for minority and indigenous groups.

Objective: The primary aim of the current study was to synthesize evidence of the effect of social media use compared with no social media use as part of interventions to reduce risk factors for noncommunicable diseases. Data Sources: Databases were searched up to June 10, 2014, using medical subject headings. A secondary aim of this study was to assess the effectiveness of social media use compared with no social media use in reducing the risk factors for noncommunicable diseases, stratifying the results by the extent of bias on outcomes, by social media use alone, and by the levels of social presence and media richness. Study Selection: Sixteen trials (n=10 711 participants) met the inclusion criteria, but interventions mostly used social media with low levels of media richness and presence (e.g., discussion boards, bulletin boards). Data Synthesis: Meta-analysis of all trials showed no significant differences (standardized mean difference [SMD] −0.14; 95%CI −0.28 to 0.01), with similar findings for physical activity (SMD 0.07; 95%CI −0.25 to 0.38), body weight (SMD 0.07; 95%CI −0.17 to 0.20), and fruit and vegetable intake (SMD 0.39; 95%CI −0.11 to 0.89). Trials assessing social media interventions aimed at modifying risk factors for noncommunicable diseases showed that social media use improved the primary outcomes, but the overall quality of the included studies limits the generalizability of these findings. Conclusion: Further trials are warranted, especially to isolate the effect of social media use and to fully evaluate the effect of the social presence and media richness of social media platforms.

BACKGROUND: Mechanical ventilation requires an endotracheal tube. Airway management includes endotracheal suctioning, a frequent procedure for patients in the ICU. Associated risks of endotracheal suctioning include hypoxia, atelectasis, and infection. There is currently no evidence about the safety of avoiding endotracheal suction. We aimed to assess the safety of avoiding endotracheal suction, including at extubation, in cardiac surgical patients who were mechanically ventilated for ≤ 12 h. METHODS: We conducted a single-center, noninferiority, randomized controlled trial in a cardiac ICU in a metropolitan tertiary teaching hospital. Subjects were assigned to either avoidance of endotracheal suction or to usual care including endotracheal suctioning during mechanical ventilation. In total, we screened 468 patients and randomized 249 subjects (usual care, n = 125; intervention, n = 124). Subjects were elective cardiac surgical patients anticipated to receive ≤ 12 h of mechanical ventilation. The primary outcome was the P aO 2 / F IO 2 on room air 6 h after extubation, with a noninferiority margin of 10% (lower bound of one-sided 95% CI to be RESULTS: There were no differences in group characteristics at baseline. The primary analysis was a per-protocol analysis performed on 154 subjects. The median P aO 2 / F IO 2 was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI –14.3). The results were consistent when using an intention-to-treat analysis and a 97.5% CI. There were no differences between groups in complications or safety measures, including the escalation of oxygen therapy. CONCLUSIONS: Endotracheal suctioning can be safely minimized or avoided in low-risk patients who have had cardiac surgery and are expected to be ventilated for

To assess the safety and efficacy of avoiding endotracheal suction in postoperative cardiac surgical patients mechanically ventilated for ≤ 12 hr.A prospective, single centre, single blind, non-inferiority, randomized controlled trial evaluating the safety and efficacy of avoiding suction in uncomplicated, postoperative, adult cardiac surgical patients mechanically ventilated for ≤ 12 hr.Randomization will be performed on return to intensive care (ICU) with allocation to either usual postoperative care including suction or to usual care with no suction (intervention arm). The primary outcome is the ratio of partial pressure of oxygen (PaOEndotracheal suction is performed as part of airway management but has potential complications and there is little robust evidence to guide practice. This study will add to the evidence base about the need and benefit of endotracheal suction in this patient cohort.As there is currently no published evidence about the safety of avoiding endotracheal suction. This study will provide the first evidence about avoidance of endotracheal suction in patients ventilated for less than 1 day. If non-inferior, the results have the capacity to change nursing practice by avoiding a potentially unnecessary procedure, it will build on the body of knowledge about the patient experience.目的: 评价机械通气小于等于12小时的心脏手术患者术后避免气管内吸引的安全性和疗效。 设计: 这是一项具有前瞻性、单中心、单盲、非劣性的随机对照试验,将评估机械通气小于等于12小时的无并发症的成年心脏手术患者术后避免吸入的安全性和疗效。 方法: 在患者返回重症监护室(ICU)时对其进行随机分组,分为包含吸入的常规术后护理组和不包含吸入的常规护理组(干预组)。主要结果是拔管6小时后氧分压(PaO2)与吸入氧浓度(FiO2)的比值(P/F)不同。将分别在实施气管内吸引(ETS)之前、之中和之后进行疼痛评估,并在第二天对患者的体验通过简短的访谈进行调查。本研究于2015年10月获得伦理批准。 讨论: 气管内吸引是作为气道管理的一部分实施的,但有潜在的并发症,而且没有有力的证据来指导实践。本研究将为对此患者群体实施气管内吸引的必要性和益处增加证据基础。 影响: 因为目前还没有关于避免气管内吸引的安全性的公开证据。这项研究将为供氧不足1天的患者气管内吸引的避免情况提供第一个证据。如果结果是非劣性的,其则能通过避免潜在不必要的程序来改变护理实践。这将建立在对患者体验的认识基础上。.

IntroductionKeratins, filament-forming proteins found in vertebrate epithelium, are downregulated in slow-healing venous leg ulcers (VLU) compared with normal-healing VLU. Laboratory and animal model research has suggested exogenous keratins increase expression of endogenous keratins. A non-randomised controlled trial of an exogenous keratin dressing reported increased healing in slow-healing VLU. To date, no randomised controlled trial has been done to verify these promising findings.Methods and analysisThe Keratin4VLU trial is a single-blind, pragmatic, parallel group, randomised controlled trial of keratin dressings compared with usual care non-medicated dressings in patients with VLU where either (1) the ulcer area is greater than 5 cm2, (2) the ulcer has been present for more than 26 weeks or (3) both. All patients will receive compression therapy. The primary outcome is the proportion of patients with healed VLU at 24 weeks after randomisation as adjudicated by blinded review of an ulcer photograph. Secondary outcomes are time to healing, estimated change in ulcer area, change in health-related quality of life, agreement between blinded and unblinded assessors and adverse events. The analysis will be intention-to-treat on the primary and secondary outcomes (excepting health-related quality of life).Ethics and disseminationThe Keratin4VLU trial received ethical approval from the Northern A Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numberNCT02896725; Pre-results.

Background Nurse-led models of comprehensive geriatric assessment and care coordination can improve health management as well as reduce hospitalisations for high risk community dwelling older people. This study investigated the effect on healthcare utilisation of systematic case finding to identify high risk older people in the community with a subsequent comprehensive assessment and care coordination intervention by a Gerontology Nurse Specialist based in primary care. Methods This was a controlled before-after study design located within primary healthcare practices in Auckland, New Zealand. An intervention model was initiated within two primary healthcare practices and involved a screening tool to identify high risk older people with succeeding gerontology nurse specialist assessment and care coordination. The comparison group included older people who received usual care at three comparable primary healthcare practices. The primary outcome measure was acute hospital admissions. Secondary outcomes included hospital re-admissions, length of stay, emergency department presentations, residential care admissions, and community contacts. Results A total of 579 older people were posted the screening tool in the intervention group, with 517 completed screens (89% response rate) formulating the intervention group. A total of 101 older people were identified as high risk from these screens (20%). The comparison group comprised 883 older people. Comparing the intervention and comparison group, no statistical differences were found for hospital admissions, emergency department presentations, hospital re-admissions, length of stay, or residential care admission. Community physiotherapy showed a statistically significant increase for the intervention compared to the comparison group (p = 0.03). Non-significant findings revealed decreased risk of entering residential care and fewer frequent hospital re-admissions for the intervention group when compared with the comparison group. Conclusions This specialist nurse-led intervention involving comprehensive assessment and care coordination care did not appear superior to usual care, however, there is benefit to exploring a more robust randomised controlled trial design. Trial registration Retrospectively registered on 18/09/2017 with the Australian New Zealand Clinical Trials Registry (ANZCTR). Registration number ACTRN12617001332314 Electronic supplementary material The online version of this article (10.1186/s12877-018-0717-3) contains supplementary material, which is available to authorized users.

Objective To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements. Methods The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data. Results Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14–6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01–5.34) and completeness of follow up (RR 1.77, 95%CI 1.02–3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18–7.19 and RR 1.69, 95%CI 1.08–2.64, respectively). Conclusion Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements.

Objective To determine the effect of low dose aspirin on ulcer healing in patients with venous leg ulcers. Design Pragmatic, community based, parallel group, double blind, randomised controlled trial. Setting Five community nursing centres in New Zealand. Participants 251 adults with venous leg ulcers who could safely be treated with aspirin or placebo: 125 were randomised to aspirin and 126 to placebo. Interventions 150 mg oral aspirin daily or matching placebo for up to 24 weeks treatment, with compression therapy as standard background treatment. Main outcome measures The primary outcome was time to complete healing of the reference ulcer (largest ulcer if more than one ulcer was present). Secondary outcomes included proportion of participants healed, change in ulcer area, change in health related quality of life, and adverse events. Analysis was by intention to treat. Results The median number of days to healing of the reference ulcer was 77 in the aspirin group and 69 in the placebo group (hazard ratio 0.85, 95% confidence interval 0.64 to 1.13, P=0.25). The number of participants healed at the endpoint was 88 (70%) in the aspirin group and 101 (80%) in the placebo group (risk difference −9.8%, 95% confidence interval −20.4% to 0.9%, P=0.07). Estimated change in ulcer area was 4.1 cm2 in the aspirin group and 4.8 cm2 in the placebo group (mean difference −0.7 cm2, 95% confidence interval −1.9 to 0.5 cm2, P=0.25). 40 adverse events occurred among 29 participants in the aspirin group and 37 adverse events among 27 participants in the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7, P=0.71). Conclusion Our findings do not support the use of low dose aspirin as adjuvant treatment for venous leg ulcers. Trial registration ClinicalTrials.gov NCT02158806.

Background: Given the context of ageing populations globally, there are a growing number of patients with chronic conditions, some of whom are in the final stages of their disease trajectory, presenting to Emergency Departments. Aim: The aim was to estimate the incidence of patients with palliative care needs presenting to the department. Methods: Three databases (MEDLINE, CINAHL and Embase) were systematically searched up to August 2012. The reference lists of included articles were searched as well as Google and Google Scholar. Only studies in English were included. Two reviewers independently reviewed studies at the abstract and full-body stages. A critical review using systematic methods was undertaken as statistical analysis could not be done because of a lack of information. Results: Only 10 of 1427 identified records met the inclusion criteria. Different definitions of palliative care were evident. One article provided an incidence density for patients with non-small cell lung cancer, and we calculated the mean presentations to be 52.5 per 100 person-months. Two articles focussed on patients known to palliative care services; we estimated that 2.5 in 1000 Emergency Department visits were made by these patients. The review demonstrated that the studies were so different it was not possible to compare the data. Conclusion: There is an absence of evidence regarding the incidence of patients with palliative care needs presenting to the Emergency Department. Further research needs to be undertaken in this area to ensure both clinicians and policymakers have sufficient information for service provision.

Families are recommended as the agents of change for weight loss in overweight and obese children; family approaches are more effective than those that focus on the child alone. However, interventions that focus on parents alone have not been summarized. The objective of this review was to assess the effectiveness of interventions that compared a parent-only (PO) condition with a parent-child (PC) condition. Four trials using a similar between-group background approaches to overweight and obese children's weight loss met the inclusion criteria, but only one trial reported sufficient data for meta-analysis. Further information was obtained from authors. Meta-analysis showed no significant difference in z-BMI from baseline to end of treatment between the conditions (three trials) or to end of follow up (two trials). The trials were at risk of bias and no single trial was at lower risk of bias than others. There is an absence of high quality evidence regarding the effect of parent-only interventions for weight loss in children compared to parent-child interventions, but current evidence suggests the need for further investigation.

BACKGROUND: Chitosan, a deacetylated chitin, is a dietary supplement reported to decrease body weight. It is widely available over the counter worldwide and although evaluated in a number of trials its efficacy remains in dispute. OBJECTIVES: To assess the effects of chitosan as a treatment for overweight and obesity. SEARCH STRATEGY: We searched electronic databases (MEDLINE, EMBASE, BIOSIS, CINAHL, The Cochrane Library), specialised web sites (Controlled Trials, IBIDS, SIGLE, Reuter's Health Service, Natural Alternatives International, Pharmanutrients), bibliographies of relevant journal articles, and contacted relevant authors and manufacturers. SELECTION CRITERIA: Trials were included in the review if they were randomised controlled trials of chitosan for a minimum of four weeks duration in adults who were overweight or obese. Authors of included studies were contacted for additional information where appropriate. DATA COLLECTION AND ANALYSIS: Details from eligible trials were extracted independently by two reviewers using a standardised data extraction form. Differences in data extraction were resolved by consensus. Continuous data were expressed as weighted mean differences and standard deviations. The pooled effect size was computed by using the inverse variance weighted method. MAIN RESULTS: Fifteen trials including a total of 1219 participants met the inclusion criteria. No trial to date has measured the effect of chitosan on mortality or morbidity. Analyses indicated that chitosan preparations result in a significantly greater weight loss (weighted mean difference -1.7 kg; 95% confidence interval (CI) -2.1 to -1.3 kg, P < 0.00001), decrease in total cholesterol (-0.2 mmol/L [95% CI -0.3 to -0.1], P < 0.00001), and a decrease in systolic and diastolic blood pressure compared with placebo. There were no clear differences between intervention and control groups in terms of frequency of adverse events or in faecal fat excretion. However, the quality of many studies was sub-optimal and analyses restricted to studies that met allocation concealment criteria, were larger, or of longer duration showed that such trials produced substantially smaller decreases in weight and total cholesterol. AUTHORS' CONCLUSIONS: There is some evidence that chitosan is more effective than placebo in the short-term treatment of overweight and obesity. However, many trials to date have been of poor quality and results have been variable. Results obtained from high quality trials indicate that the effect of chitosan on body weight is minimal and unlikely to be of clinical significance.

In 2011, we demonstrated that an individualized health management system employing advanced medical information technology, designated ubiquitous (u)-healthcare, was helpful in achieving glycemic control without hypoglycemia in patients with diabetes. Following this, we generated a new multidisciplinary u-healthcare system by upgrading our clinical decision support system (CDSS) rule engine and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. In a randomized, controlled clinical trial, patients with type 2 diabetes aged over 60 years were assigned randomly to a self-monitored blood glucose (SMBG) group (N = 50) or u-healthcare group (N = 50) for 6 months. The primary endpoint was the proportion of patients achieving glycated hemoglobin (HbA1c)

Background Postoperative respiratory complications following cardiac surgery may increase morbidity, mortality and length of stay. Non-invasive respiratory support therapies can be used prophylactically or curatively to reduce respiratory complications. One system, nasal high flow oxygen therapy, is in use in many intensive care units (ICUs) however there is a lack of information regarding its clinical utility and efficacy. Objectives This paper outlines the study protocol and methodology for a study designed to determine if the prophylactic use of nasal high flow oxygen therapy can improve pulmonary function in patients following cardiac surgery. Methods/design A prospective randomised controlled trial will be conducted of adult patients scheduled for cardiac surgery and admitted to the Cardiothoracic Intensive Care Unit of a tertiary hospital. Study participants will be assigned to receive either nasal high flow or standard oxygen therapy (oxygen therapy at 2–4L/min via either simple facemask or nasal cannulae) at extubation. The primary outcome measure is improved pulmonary function demonstrated by SpO 2 /FiO 2 ratio >445 on post-operative day 3. Secondary outcome measures include atelectasis score on chest X-ray; spirometry; readmission to ICU for respiratory causes; ICU and hospital length of stay; mortality and incidence of respiratory complications at day 28; oxygenation variables; use of adjunctive respiratory support therapies; escalation of respiratory support; adverse events and patient comfort during administration of oxygen therapy. Sample size It was calculated that 340 patients will be required – 170 per arm of study – to give a 90% power to detect a 15% treatment effect. Results This study started recruiting in March 2011. It is anticipated that enrolment will be complete in April 2012 and results available towards the end of 2012. Conclusion This study will provide evidence of any benefits in the use of prophylactic nasal high flow therapy in post-operative cardiac surgical patients. Trial registration This trial is registered with the Australian New Zealand Clinical Trials Registry www.anzctr.org.au (ACTRN12610000973011).

Background: The surge in the incidence of obesity and being overweight demands new options to extend the reach of weight-loss interventions. Mobile phones provide a medium for reaching large numbers of people in a cost-effective manner. The present study aimed to explore the potential for weight-loss interventions to be delivered via mobile phone. Methods: A mixed methods approach was employed. A telephone survey was conducted with 306 randomly selected participants, and 10 focus groups were undertaken with 54 purposively selected participants. The telephone survey comprised questions exploring the nature and acceptability of any potential weight-loss programme that might be delivered via mobile phones. The focus groups were conducted to explore issues of acceptability in more depth than was possible in the survey. Results: Two-thirds of participants reported support for a mobile phone weight-loss intervention, with greater levels of support amongst younger age groups and rural Māori (the indigenous population in New Zealand). Participants liked the idea of ready access to weight-loss information, and associated feedback and encouragement. The results suggest that interventions would need to include aspects of social support, use tailored and personalised content, and be practical and relevant so that they appeal to consumers. Appropriate methods of providing social support using a mobile phone require further exploration. Conclusions: Mobile phones may provide a novel but acceptable way to deliver a weight-loss intervention. They have the potential to be automatically personalised and tailored to the needs of the individual, at the same time as being delivered at a population level.

Importance Exercise is recommended as an adjuvant treatment for venous leg ulceration (VLU) to improve calf muscle pump function. However, the association of exercise with VLU healing has not been properly aggregated, and the effectiveness of different exercise interventions has not been characterized. Objective To summarize the association of different exercise interventions with VLU healing when used as an adjuvant to any form of compression. Data Sources The Cochrane Controlled Trials Register, MEDLINE, Embase, CINAHL, PsycInfo, and SCOPUS databases were searched through October 9, 2017. Study Selection Randomized clinical trials (RCTs) of any exercise compared with no exercise in participants with VLU were included, where compression was used as standard therapy and a healing outcome was reported. Independent title screening and full text review by 2 authors (A.J., J.S.) with appeal to a third author (J.P.) if disagreement was unresolved. Of the 519 articles screened, a total of 6 (1.2%) studies met the inclusion criteria for systematic review, including 5 for meta-analysis. Data Extraction and Synthesis Independent quality assessment for Cochrane risk of bias and data extraction by 2 authors with appeal to third author if disagreement unresolved (PRISMA). Data pooled using fixed effects model. Main Outcomes and Measures The a priori primary outcome was any healing outcome (proportion healed, time to healing, or change in ulcer area). Secondary outcomes (adverse events, costs, and health-related quality of life) were only collected if a primary outcome was reported. Results Six RCTs were identified and 5 (190 participants) met inclusion criteria for meta-analysis. The exercise interventions were progressive resistance exercise alone (2 RCTs, 53 participants) or combined with prescribed physical activity (2 RCTs, 102 participants), walking only (1 RCT, 35 participants), or ankle exercises (1 RCT, 40 participants). Overall, exercise was associated with increased VLU healing at 12 weeks although the effect was imprecise (additional 14 cases healed per 100 patients; 95% CI, 1-27 cases per 100;P = .04). The combination of progressive resistance exercise plus prescribed physical activity appeared to be most effective, again with imprecision (additional 27 cases healed per 100 patients; 95% CI, 9-45 cases per 100;P = .004). Conclusions and Relevance The evidence base may now be sufficiently suggestive for clinicians to consider recommending simple progressive resistance and aerobic activity to suitable patients with VLU while further research is produced.

Objectives This pilot study evaluated the feasibility (recruitment, retention, and acceptability) and preliminary efficacy of a six-week home-based electronic time monitor intervention on New Zealand children's television watching in 2008. Methods Twenty-nine children aged 9 to 12 years who watched more than 20 h of television per week (62% male, mean age 10.4 years) were randomised to either the intervention or the control group. The intervention group received an electronic TV time monitor for 6 weeks and advice to restrict TV watching to 1 h per day or less. The control group was given verbal advice to restrict TV watching. Results Participant retention at 6 weeks was 93%. Semi-structured interviews with intervention families confirmed moderate acceptability of TV time monitors and several perceived benefits including better awareness of household TV viewing and improved time planning. Drawbacks reported included disruption to parents' TV watching and increased sibling conflict. Time spent watching television decreased by 4.2 h (mean change [SD]: −254 [536] min) per week in the intervention group compared with no change in the control group (−3 [241] min), but the difference between groups was not statistically significant, p = 0.77. Both groups reported decreases in energy intake from snacks and total screen time and increases in physical activity measured by pedometer and between-group differences were not statistically significant. Conclusions Electronic TV time monitors are feasible to use for home-based TV watching interventions although acceptability varies between families. Preliminary findings from this pilot suggest that such devices have potential to decrease children's TV watching but a larger trial is needed to confirm effectiveness. Future research should be family-orientated; take account of other screen time activities; and employ TV time monitors as just one of a range of strategies to decrease sedentary behaviour.

To determine the effect of Vibration Training (VT) on functional ability and falls risk among a group of frail older people admitted to an inpatient rehabilitation unit in a regional hospital in New Zealand.A randomized controlled trial of 56 participants (mean 82.01 years in the intervention group and 81.76 years in the control group). VT targeting lower limb muscles with a frequency 30-50 Hz occurred three times per week until discharge. Amplitude progressively increased from 2 to 5 mm to allow the programme to be individually tailored to the participant. The control group received usual care physiotherapy sessions. Outcome measures were: Physiological profile assessment (PPA); and Functional Independence measure (FIM) and Modified Falls Efficacy Scale (MFES).There was a statistically significant difference observed between the two groups in terms of FIM score (F = 5.09, p = 0.03) and MFES (F = 3.52, p = 0.007) but no difference was observed in terms of PPA scores (F = 0.96, p = 0.36).Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of VT in conjunction with usual care physiotherapy in terms of improved functional ability. The study design and the small dosage of VT provided may have precluded any change in falls risk among participants.Vibration training (VT) may assist in reducing the risk of falling among at risk older people. Current pressures on health systems (ageing population, reduced hospital length of stay) necessitate the development of innovative strategies to maximise the rehabilitation potential of older people. Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of vibration training in conjunction with usual care physiotherapy in terms of improved functional ability.

Aim The aim of this study was to determine the effect of low-dose aspirin on venous leg ulcer healing when used in addition to compression. Background The mainstay of treatment for venous leg ulcers is compression therapy and there are few adjuvant treatments to accelerate healing. Design Pragmatic, community-based, double-blind, randomized trial. Methods Participants with venous leg ulcers will receive either 150 mg aspirin or placebo daily for up to 24 weeks. Participants will receive background treatment with compression therapy (system of choice guided by participant and/or clinical preference) delivered through district nursing services. The primary outcome will be time-to-healing. Secondary outcomes will include proportion healed at 24 weeks, change in ulcer area, change in health-related quality of life, adherence, efficacy of blinding and adverse events. The trial was funded in June 2014. Discussion The trial commenced in March 2015 and is successfully recruiting. The trial is one of three trials that will contribute to an individual participant data meta-analysis to be undertaken at the York Trials Centre. Trial registration Registered 5 June 2014 ClinicalTrials.gov NCT02158806. Protocol version 1·1, 14 April 2015.

Aims To describe a surveillance approach for monitoring the effect of improvement initiatives on hospital-acquired pressure injuries and findings arising from that surveillance. Methods Random sampling of patients on the same day of each successive month from a campus of child and adult hospitals using a standard audit tool to identify presence of hospital-acquired pressure injury. Where multiple pressure injuries were present, the most severe grade injury contributed to prevalence. Statistical process control charts were used to monitor monthly performance and Maximum Likelihood Estimation to determine timing of step change. Results 8274 patients were assessed over 3 years from an eligible population of 32,259 hospitalised patients. 517 patients had hospital-acquired pressure injuries giving an overall prevalence of 6.2% (95% CI 5.7–6.8%). Annual prevalence was 8.4% (95% CI 7.4–9.5%) in the first year, falling to 5.6% (95% CI 4.7–6.4%) in the second year and 4.8% (95% CI 4.0–5.6%) in the third year. A step change was signalled with mean prevalence up to July 2013 being 7.9% (95% CI 7.1–8.8%) and mean prevalence thereafter 4.8% (95% CI 4.2–5.4%). Hospital-acquired pressure injuries were found in all age ranges, but were more frequent in children up to 14 years (17.4%) and those aged 75 years or older (38.7%). Conclusion Monthly random sampling of patients within clinical units can be used to monitor performance improvement. This approach represents a rational alternative to cross-sectional prevalence surveys especially if the focus is on performance improvement.

We evaluated the effects of an active videogame (AVG) intervention (Sony [Tokyo, Japan] PlayStation(®) EyeToy(®)) compared with non-AVGs on body composition, physical activity, sedentary behavior, and snack food consumption among overweight 10-12-year-old children over 24 weeks. Our research showed a treatment effect on body mass index and percentage body fat in favor of the intervention group. There was no difference between groups for total physical activity levels, but there was an increase in self-reported AVG play and reductions in non-AVG play and snack food consumption in the intervention group. Research is needed to determine how to augment the effects observed in this study.

Previous Users’ guides have described the evaluation of studies of the effectiveness of a treatment or intervention and studies of causation or aetiology (ie, studies assessing the relation between certain exposures and the development of a specific disease or condition). This Users’ guide will focus on related questions of the harmful effects of interventions or treatments—ie, the undesirable outcomes of treatments prescribed by healthcare providers. The criteria are those identified in the original JAMA users’ guide by Levine et al .1 Before we get started, a few preliminary notes. The concepts and criteria used to evaluate observational studies of treatment harm are the same as those used to assess studies of causation or aetiology. For example, an observational study may be conducted to determine the effects of second hand smoke in the home on the development of asthma in children. In such a study, children exposed to second hand smoke would be compared with those who were not exposed to see if the exposed and unexposed groups differed in terms of developing asthma. In this Users’ guide, we will be focusing on the harms of a treatment or intervention . For example, a study by Madsen et al assessed whether children who received mumps, measles, and rubella (MMR) vaccinations (intervention group) were more likely to develop autism than those who did not receive vaccinations (control group).2 In this Users’ guide, we will primarily refer to the intervention group (the equivalent of the exposed group) and the control group (the unexposed group). When considering studies of treatment harm, readers may encounter various terms used to refer to “harm”—studies may refer to risks, adverse events, side effects (often in relation to drugs), or the safety of an intervention. You are a nurse practitioner working in a paediatric primary care clinic. …

Objectives: to quantify the effect of leg ulceration on health-related quality of life and to estimate a health state value for leg ulceration. Design: population based case-control study. Setting: two New Zealand health districts (population 540,468 people). Subjects: 241 people with a leg ulcer of any aetiology, and 224 controls randomly selected from the electoral roll using stratiWed sampling. Main outcome measures: health-related quality of life as measured by the eight domains of the Short Form 36 question Health Survey, adjusted for age, sex and confounding co-morbidities; the physical component summary and mental component summary scores of the Short Form 36 question Health Survey standardised for age and sex; preference-based health state value derived from the Short Form 36 question Health Survey. Results: completed Short Form 36 question Health Survey questionnaires were available for 230 cases (95%) and 218 controls (97%). Cases reported signiWcantly lower mean scores than controls across all eight domains of the Short Form 36 question Health Survey (P < 0.0005). Mean domain scores for cases were also signiWcantly lower than population norms. The mean physical component summary score for cases and controls was 45.2 versus 50.1 (P < 0.0001) and the mean mental component summary score was 48.1 for cases versus 51 for controls (P < 0.0001). The mean health state values (adjusted for age and sex) were 0.80 for cases and 0.89 for controls. Conclusion: leg ulcers reduce quality of life to a similar extent as other common chronic conditions, such as arthritis and diabetes.

Summary Introduction Venous ulcers are usually treated with compression therapy, but, because this treatment may not be effective for some people, adjuvant therapy could be beneficial. We did a systematic review of randomised controlled trials that compared pentoxifylline (with and without compression treatment) with placebo, or other treatments, in patients with venous leg ulcers. Methods We identified eight trials (547 adults), five of which compared pentoxifylline and compression with placebo and compression (n=445), and three of which compared pentoxifylline alone with placebo (102). Our main aim was to determine whether pentoxifylline, with or without compression, was effective in treatment of venous leg ulcers. Analysis was by intention to treat. Findings Pentoxifylline was more effective than placebo in complete healing or substantial improvement of venous leg ulcers (relative risk 1·49, 95% CI 1·11-2·01). Pentoxifylline with compression was also more effective than placebo and compression in complete healing (1·30, 1·10-1·54). Patients taking pentoxifylline had no more adverse events than those on placebo (1·25, 0·87-1·80). The most frequent adverse event was mild gastrointestinal disturbance (43%). Interpretation Our results suggest that pentoxifylline gives additional benefit to compression for venous leg ulcers, and is possibly effective for patients not receiving compression.

Background Respiratory complications after cardiac surgery increase morbidity, mortality, and length of stay. Studies suggest that routine delivery of positive airway pressure after extubation may be beneficial. We sought to determine whether the routine administration of nasal high-flow oxygen therapy (NHF) improves pulmonary function after cardiac surgery. Methods A pragmatic randomized controlled trial; participants received either NHF (45 litre min −1 ) or usual care from extubation to Day 2 after surgery. The primary outcome was number of patients with S p O 2 / F I O 2 ratio ≥445 on Day 3 after surgery. The secondary outcomes included atelectasis score on chest X-ray; spirometry; intensive care and hospital length of stay; mortality on Day 28; oxygenation indices; escalation of respiratory support; and patient comfort. Results We randomized 340 patients over 14 months. The number of patients with a S p O 2 / F I O 2 ratio of ≥445 on Day 3 was 78 (46.4%) in the NHF group vs 72 (42.4%) standard care [odds ratio (OR) 1.18, 95% confidence interval (CI) 0.77–1.81, P =0.45]. P a CO 2 was reduced at both 4 h post-extubation and at 9 a.m. on Day 1 in the NHF group (5.3 vs 5.4 kPa, P =0.03 and 5.1 vs 5.3 kPa, P =0.03, respectively). Escalation in respiratory support at any time in the study occurred in 47 patients (27.8%) allocated to NHF compared with 77 (45%) standard care (OR 0.47, 95% CI 0.29–0.7, P =0.001). Conclusions Routine use of NHF did not increase S p O 2 / F I O 2 ratio on Day 3 but did reduce the requirement for escalation of respiratory support. Trial Registration Australia New Zealand Clinical Trials Registry www.anzctr.org.au (ACTRN12610000973011).

Background Forearm blood pressures have been suggested as an alternative site to measure blood pressures when the upper arm is unavailable. However there is little evidence utilising clinical populations to support this substitution. Objectives To determine agreement between blood pressures measured in the left upper arm and forearm using a singular oscillometric non-invasive device in adult Emergency Department patients. The secondary objective was to explore the relationship of blood pressure differences with age, sex, ethnicity, smoking history and obesity. Design Single centre comparison study. Setting Adult Emergency Department, Tertiary Trauma Centre. Participants Forty-four participants who met inclusion/exclusion criteria selected sequentially from the Emergency Department arrival board. Methods A random assignment of order of measurement for left upper arm and forearm blood pressures was utilised. Participants were eligible if they were aged 18 years or older, had been assigned an Australasian Triage Scale code of 2, 3, 4, or 5, were able to consent, and able to have blood pressures measured on their left arm whilst lying at a 45° angle. The Bland–Altman method of statistical analysis was used, with the level of agreement for clinical acceptability for the systolic, diastolic and mean arterial pressure defined as ±10mmHg. Results The forearm measure overestimated systolic (mean difference 2.2mmHg, 95% limits of agreement ±19mmHg), diastolic (mean difference 3.4mmHg, 95% limits of agreement ±14.4mmHg), and mean arterial pressures (mean difference 4.1mmHg, 95% limits of agreement ±13.7mmHg). The systolic measure was not significantly different from zero. Evidence of better agreement was found with upper arm/forearm systolic measures below 140mmHg compared to systolic measures above 140mmHg using the Levene's test ( p =0.002, F -statistic=11.09). Blood pressure disparity was not associated with participant characteristics. Conclusions Forearm measures cannot routinely replace upper arm measures for blood pressure measurement. If the clinical picture requires use of forearm blood pressure, the potential variance from an upper arm measure is ±19mmHg for systolic pressure, although the variability may be close to ±10mmHg if the systolic blood pressure is below 140mmHg.

BACKGROUND: Honey is a viscous, supersaturated sugar solution derived from nectar gathered and modified by the honeybee, Apis mellifera. Honey has been used since ancient times as a remedy in wound care. Evidence from animal studies and some trials has suggested that honey may accelerate wound healing. OBJECTIVES: The objective of this review was to assess the effects of honey compared with alternative wound dressings and topical treatments on the of healing of acute (e.g. burns, lacerations) and/or chronic (e.g. venous ulcers) wounds. SEARCH METHODS: For this update of the review we searched the Cochrane Wounds Group Specialised Register (searched 15 October 2014); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 9); Ovid MEDLINE (1946 to October Week 1 2014); Ovid MEDLINE (In‐Process & Other Non‐Indexed Citations 13 October 2014); Ovid EMBASE (1974 to 13 October 2014); and EBSCO CINAHL (1982 to 15 October 2014). SELECTION CRITERIA: Randomised and quasi‐randomised trials that evaluated honey as a treatment for any sort of acute or chronic wound were sought. There was no restriction in terms of source, date of publication or language. Wound healing was the primary endpoint. DATA COLLECTION AND ANALYSIS: Data from eligible trials were extracted and summarised by one review author, using a data extraction sheet, and independently verified by a second review author. All data have been subsequently checked by two more authors. MAIN RESULTS: We identified 26 eligible trials (total of 3011 participants). Three trials evaluated the effects of honey in minor acute wounds, 11 trials evaluated honey in burns, 10 trials recruited people with different chronic wounds including two in people with venous leg ulcers, two trials in people with diabetic foot ulcers and single trials in infected post‐operative wounds, pressure injuries, cutaneous Leishmaniasis and Fournier's gangrene. Two trials recruited a mixed population of people with acute and chronic wounds. The quality of the evidence varied between different comparisons and outcomes. We mainly downgraded the quality of evidence for risk of bias, imprecision and, in a few cases, inconsistency. There is high quality evidence (2 trials, n=992) that honey dressings heal partial thickness burns more quickly than conventional dressings (WMD ‐4.68 days, 95%CI ‐5.09 to ‐4.28) but it is unclear if there is a difference in rates of adverse events (very low quality evidence) or infection (low quality evidence). There is very low quality evidence (4 trials, n=332) that burns treated with honey heal more quickly than those treated with silver sulfadiazine (SSD) (WMD ‐5.12 days, 95%CI ‐9.51 to ‐0.73) and high quality evidence from 6 trials (n=462) that there is no difference in overall risk of healing within 6 weeks for honey compared with SSD (RR 1.00, 95% CI 0.98 to 1.02) but a reduction in the overall risk of adverse events with honey relative to SSD. There is low quality evidence (1 trial, n=50) that early excision and grafting heals partial and full thickness burns more quickly than honey followed by grafting as necessary (WMD 13.6 days, 95%CI 9.82 to 17.38). There is low quality evidence (2 trials, different comparators, n=140) that honey heals a mixed population of acute and chronic wounds more quickly than SSD or sugar dressings. Honey healed infected post‐operative wounds more quickly than antiseptic washes followed by gauze and was associated with fewer adverse events (1 trial, n=50, moderate quality evidence, RR of healing 1.69, 95%CI 1.10 to 2.61); healed pressure ulcers more quickly than saline soaks (1 trial, n= 40, very low quality evidence, RR 1.41, 95%CI 1.05 to 1.90), and healed Fournier’s gangrene more quickly than Eusol soaks (1 trial, n=30, very low quality evidence, WMD ‐8.00 days, 95%CI ‐6.08 to ‐9.92 days). The effects of honey relative to comparators are unclear for: venous leg ulcers (2 trials, n= 476, low quality evidence); minor acute wounds (3 trials, n=213, very low quality evidence); diabetic foot ulcers (2 trials, n=93, low quality evidence); Leishmaniasis (1 trial, n=100, low quality evidence); mixed chronic wounds (2 trials, n=150, low quality evidence). AUTHORS' CONCLUSIONS: It is difficult to draw overall conclusions regarding the effects of honey as a topical treatment for wounds due to the heterogeneous nature of the patient populations and comparators studied and the mostly low quality of the evidence. The quality of the evidence was mainly downgraded for risk of bias and imprecision. Honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin‐impregnated gauze, sterile linen and leaving the burns exposed) and infected post‐operative wounds more quickly than antiseptics and gauze. Beyond these comparisons any evidence for differences in the effects of honey and comparators is of low or very low quality and does not form a robust basis for decision making.

Objective: To investigate the factors influencing patient concordance with compression stockings after venous leg ulcer healing. Method: In 2001 patients discharged from a specialist leg ulcer service in New Zealand were approached to participate in a structured interview about their use of compression stockings in the first six months following venous leg ulcer healing. Univariate analyses were performed to identify significant associations between factors and stocking use. Multiple logistic regression was employed to model the factors associated with frequency of stocking use. Results: A total of 163 patients were identified, of whom 129 (79%) agreed to participate. Sixty-seven (52%) reported wearing stockings every day for the first six months after their ulcers had healed, 21 (16%) stated that they had worn them most days, seven (5%) had worn them occasionally and 29 (22%) had not worn them at all after their ulcer had healed. Five (4%) did not provide data. Two factors distinguished those who wore stockings from those who did not 75% of the time: the belief that wearing stockings was worthwhile and the belief that stockings were uncomfortable to wear. Commonly cited factors, such as age, sex, difficulty in applying stockings and cosmetic appearance were not significantly related to stocking use. Cost did not seem to influence the decision to purchase compression stockings. Conclusion: Many factors previously thought to influence concordance appear to have little impact on compression-stocking use in people whose venous leg ulcers had healed. Declaration of interest: None.

Background Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers remain unhealed, and some people are unsuitable for compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers but to date there has been no systematic review. Objectives To assess the effects of pentoxifylline (oxpentifylline or Trental 400) for treating venous leg ulcers, compared with placebo, or other therapies, in the presence or absence of compression therapy. Search strategy We searched the Cochrane Peripheral Vascular Diseases and Wounds Groups specialised registers (date of last search was May 2001), and reference lists of relevant articles. We hand searched relevant journals and conference proceedings, and contacted Hoechst (the manufacturer of the drug) and experts in the field. Selection criteria Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in patients with venous leg ulcers. Data collection and analysis Details from eligible trials were extracted and summarised by one reviewer using a coding sheet. Data extraction was independently verified by one other reviewer. Main results Nine trials involving 572 adults were included. The quality of trials was variable. Eight trials compared pentoxifylline with placebo; in five of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. Combining eight trials that compared pentoxifylline with placebo (with or without compression) demonstrated that pentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (relative risk of healing with pentoxifylline compared with placebo 1.41, 95% confidence interval 1.19 -1.66). Pentoxifylline plus compression is more effective than placebo plus compression (relative risk of healing with pentoxifylline 1.30, 95% confidence interval 1.10-1.54). A comparison between pentoxifylline and defibrotide found no statistically significant difference in healing rates. More adverse effects were reported in patients receiving pentoxifylline, although this was not statistically significant (relative risk of adverse effects with pentoxifylline 1.25, 95% confidence interval 0.87-1.80). Nearly half of the reported adverse effects were gastrointestinal. Authors' conclusions Pentoxifylline appears to be an effective adjunct to compression bandaging for treating venous ulcers. There was no cost effectiveness data available and healthcare commissioners may therefore conclude that it not be considered a routine adjunct. Pentoxifylline in the absence of compression may be effective for treating venous leg ulcers, although the evidence should be cautiously interpreted. The majority of adverse effects are gastrointestinal disturbances (indigestion, diarrhoea and nausea).

Background Increased understanding of why and how physical activity impacts on health outcomes is needed to increase the effectiveness of physical activity interventions. A recent randomized controlled trial of an active video game (PlayStation EyeToy™) intervention showed a statistically significant treatment effect on the primary outcome, change from baseline in body mass index (BMI), which favored the intervention group at 24 weeks. In this short paper we evaluate the mediating effects of the secondary outcomes. Objective To identify mediators of the effect of an active video games intervention on body composition. Methods Data from a two-arm parallel randomized controlled trial of an active video game intervention (n = 322) were analyzed. The primary outcome was change from baseline in BMI. A priori secondary outcomes were considered as potential mediators of the intervention on BMI, including aerobic fitness (VO2Max), time spent in moderate-to-vigorous physical activity (MVPA), and food snacking at 24 weeks. Results Only aerobic fitness at 24 weeks met the conditions for mediation, and was a significant mediator of BMI. Conclusion Playing active video games can have a positive effect on body composition in overweight or obese children and this effect is most likely mediated through improved aerobic fitness. Future trials should examine other potential mediators related to this type of intervention. Trial registration Australian New Zealand Clinical Trials Registry Website: http://www.anzctr.org.au Study ID number: ACTRN12607000632493

The aim of the study was to evaluate the responsiveness of the Short Form Health Survey, the EuroQol 5 Dimension questionnaire, and the Charing Cross Venous Ulcer Questionnaire (CXVUQ) to venous ulcer healing. Participants had health-related quality of life measured at baseline and 12 weeks. Standardized response means were calculated to assess the responsiveness of the instruments to change in an ulcer state (healed vs. unhealed). Three hundred and sixty-eight participants completed the questionnaires at baseline and 360 at 12 weeks. One hundred and ninety-three participants (54%) had healed at 12 weeks. The standardized response means ranged from -0.01 to 0.47 for Short Form Health Survey, 0.10-0.31 for EuroQol 5 Dimension questionnaire, and -0.21 to -0.92 for CXVUQ. Differences between healed and unhealed participants at 12 weeks were significantly different for three of the eight domains on Short Form Health Survey and on all domains for the CXVUQ. There were no significant differences between the groups on the EuroQol 5 Dimension questionnaire scales. CXVUQ was more responsive than the generic instruments to change in ulcer status over 12 weeks for measuring health-related quality of life of patients with venous ulceration.

Background Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children. Methods/Design Three hundred and thirty participants aged 10–14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention). Discussion An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000632493