A simple index to predict healing in venous leg ulcers: a secondary analysis from four randomised controlled trials.

OBJECTIVE: To investigate whether the use of a simple baseline measurement predicts venous leg ulcer healing at 12 and 24 weeks. METHOD: This was a secondary analysis of a cohort of four randomised controlled trials (RCTs) of treatments adjuvant to compression. Self-reported ulcer duration, and measured ulcer length and width, to calculate estimated ulcer area, were used to obtain a Margolis index score. The score created three prognostic strata for likelihood to heal within 24 weeks, and the number of participants healed and time-to-healing were compared. RESULTS: There were a total of 802 participants across the four RCTs-408 (50.9%) in two 12-week trials and 394 (49.1%) in two 24-week trials. The mean age of participants was 63.7±17.6 years, and 372 were female (46.4%). The Margolis index score at baseline was 0 for 320 participants (predicted normal healing); 1 for 334 participants; and 2 for 148 participants (both 1 and 2 predicted slow-to-heal). Overall, 248 (77.5%) of those participants who scored 0 at baseline healed within 24 weeks, compared with 182 (54.5%) of participants who scored 1, and 30 (20.3%) participants who scored 2. The median time-to-healing was 40 (24-62) days, 57 (35-100) days and 86.5 (56-151) days, respectively. The area under the receiver operating characteristic curve was 0.69 and 0.77, respectively, for the 12 and 24 week trials. CONCLUSION: A simple baseline index identifies participants with normal or slow-to-heal wounds and could be used to demonstrate prognostic balance between treatment groups in trials. This approach could also be used in clinical practice to assist with managing expectations and for early identification of patients who may best benefit from adjuvant treatments.

Evaluating the effects of triage education on triage accuracy within the emergency department: An integrative review.

INTRODUCTION: Triage accuracy can affect patient outcomes. Education to ensure nurses provide the most accurate triage scores is paramount for patient safety.The objective was to investigate whether ongoing triage education increases triage accuracy, knowledge or behaviour. METHOD: An integrative review was conducted by searching five databases to identify studies that included triage-based education. A systematic search strategy was completed followed by analysis with critical appraisal using the Critical Appraisal Skills Programme, a TIDieR Checklist and thematic analysis. FINDINGS: Four thousand five hundred seventy-six studies were retrieved, with 34 studies selected for inclusion. Thirty-one studies were quantitative, and three were mixed methods. 18 out of 34 studies showed improvement in triage accuracy. Seven showed increased knowledge. Six studies showed no improvement in triage accuracy. Sixteen studies assessed triage behaviour and showed improvement post-intervention, with five showing no changes. Only three studies compared interventions. Fifty-three opportunities for changes to triage accuracy, knowledge or behaviour were found, 41 showed improvements. CONCLUSION: Triage education interventions can improve accuracy, knowledge and behaviour, but whether improvements are sustained needs further research.

Incidence and predictors of new-onset atrial fibrillation after cardiac surgery at Auckland City Hospital.

AIM: To describe the incidence, ethnic differences in incidence, and predictors of post-operative atrial fibrillation (POAF) after cardiac surgery in a New Zealand hospital. METHOD: Analysis of registry data on 1,630 adults without previous atrial fibrillation having coronary artery bypass grafting and/or valve surgery was used to determine the incidence of POAF. Univariate analysis identified risk factors and stepwise logistic regression was used to create the most parsimonious model to predict POAF. RESULTS: Overall POAF incidence was 29% (n=465) and differed by surgery type (25% after isolated coronary artery bypass surgery (CABG) vs 42% after combined CABG+valve). Incidence was highest in Maori (35%) and NZ/Other Europeans (32%). Maori and Pasifika with POAF were on average ten years younger than NZ/Other Europeans. Independent risk factors were age (OR 1.05, 95%CI 1.04-1.06), body mass index (OR 1.04, 95%CI 1.02-1.06), history of heart failure (OR 2.08, 95%CI 1.47-2.95), and valve surgeries (isolated valve OR 1.51, 95%CI 1.16-1.95; CABG+valve OR 1.59, 95%CI 1.11-2.28), but the model had poor discrimination (AUC 0.67). CONCLUSION: POAF in a New Zealand hospital occurs at comparable rates to international settings. Risk models using routinely measured factors offer poor predictive accuracy, meaning risk stratification is unlikely to adequately inform targeted POAF prevention in clinical practice.

Trial registration and time to publication in a retrospective cohort of publicly funded randomised controlled trials in New Zealand 1999-2017.

OBJECTIVES: To determine how quickly randomised controlled trials funded by the Health Research Council of New Zealand (HRC) were registered and published, and whether time to publication differed by trial result. DESIGN: We created a retrospective cohort of trials offered funding from 1999 to 2017 by seeking lists of candidate studies using the Official Information Act 1982. These lists were supplemented by searching the HRC's online research repository and an open-access database on Figshare. One investigator searched for trial registrations and for dissemination using electronic databases, university websites and ResearchGate. One investigator extracted data from the obtained studies and a second investigator independently corroborated the data entry from a 10% random sample. RESULTS: We identified 258 trials that were offered funding, 252 trials were conducted and 229 (90.9%) were registered, 179 prospectively by the date of the final search (24 March 2022). Overall, 236 trials were completed by the date of the last search and in 209 (88.6%) trials the results had been disseminated, 200 (84.7%) of which were by journal publication. We obtained the results for 214 trials, 91 (42.5%) of which were positive, 120 (56.1%) of which were null and 3 (1.4%) of which were negative. Median time to publication was 22.7 months for positive trials and 21.5 months for combined null or negative trials (log rank test p=0.83). Median time since trial completion in the trials that had not been published was 43.6 months (IQR 17.1-108.2 months). CONCLUSIONS: Between 1999 and 2017, almost 9 out of every 10 HRC-funded trials had been registered and a similar proportion of completed trials had been published with no difference in time to publication based on type of result. However, only a slim majority of trials had published within the 2-year time frame set by the WHO.

Review article: Ankle intra-articular haematoma block for reduction of unstable ankle fractures in the emergency department: An integrative review.

A review was conducted to assess the efficacy and safety of the intra-articular haematoma block (IAHB) for manipulation of ankle fractures in ED. Any study investigating the success of IAHB for ankle fracture reduction published in English was sought. Seven databases were searched. The Cochrane Risk of Bias tool was used to quality assess the included studies. Three studies met the inclusion criteria (n = 436 patients). Just one study was a randomised controlled trial (n = 42). The two non-randomised studies that included the majority of patients were assessed as at high overall risk of bias. The studies reported no significant difference in the overall rate of successful reduction or patient-reported pain scores between IAHB and procedural sedation groups. A subgroup analysis in one study suggested timelier reduction by 51.4 min (P = 0.01) for fractures involving subluxation when using IAHB, but that more patients with dislocation were reduced on first attempt when using procedural sedation compared to IAHB (74.0% vs 54.8%, P < 0.01). No adverse events were reported from using IAHB, although no study measured events such as joint sepsis or chondrolysis. Findings suggest that IAHB might be safe and effective but the evidence is very limited. High-quality research is required before IAHB can be considered a routine alternative. However, IAHB could be considered in situations where the risk of procedural sedation outweighs the likely very low risk of chondrolysis.

Patient's experiences of endotracheal tubes and suction following cardiac surgery.

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).

Statins and venous leg ulcer healing: Secondary analysis of data from a cohort of three randomised controlled trials.

Adjuvants to compression are sought for treating venous ulceration. There is animal, observational and trial evidence that suggests statins increase venous ulcer healing. The objective of this study was to conduct secondary analyses investigating the association of statin use with healing in three randomised trials that recruited people with venous ulceration. The difference in healing rates was modest but higher in the statins group. Crude analyses found no significant difference between the groups, but when adjusted for the trial effect and potential confounders (age, diabetes, first ever ulcer, ulcer area and ulcer duration), significantly more participants healed among those taking statins. The analyses were robust to method of analysis (fixed effects or random effects models). A definitive trial is required to evaluate the effect of statins versus placebo on venous ulcer healing, but until then patients needing to take statins seem unlikely to be disadvantaged by this treatment.

Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU).

INTRODUCTION: Compression 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 ANALYSIS: The 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 DISSEMINATION: The 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 NUMBERS: Australia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).

Effect of Cardiac Surgery on Health-Related Quality of Life in Patients Aged 75 Years or Older: A Prospective Study.

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.

Exploring Pasifika wellbeing: findings from a large cluster randomised controlled trial of a mobile health intervention programme.

AIM: The primary objective of this study was to determine the effect of a mobile health (mHealth) intervention on the wellbeing of Pasifika peoples, and to explore factors associated with Pasifika wellbeing. METHODS: The OL@-OR@ mHealth programme was a co-designed smartphone app. Culturally relevant data was collected to examine holistic health and wellbeing status, at baseline, and at 12 weeks (end of the trial). The concept of wellbeing was examined as part of a two-arm, cluster randomised trial, using only the Pasifika data: 389 (of 726) Pasifika adults were randomised to receive the mHealth intervention, while 405 (of 725) Pasifika adults were randomised to receive a control version of the intervention. Culturally relevant data was collected to examine holistic health and wellbeing status, at baseline, and at 12 weeks (end of the trial). The intervention effects and the association of demographic and behavioural relationships with wellbeing, was examined using logistic regression analyses. RESULTS: Relative to baseline, there were significant differences between the intervention and control groups for the 'family/community' wellbeing, at the end of the 12-week trial. There were no significant differences observed for all other wellbeing domains for both groups. Based on our multivariate regression analyses, education and acculturation (assimilation and marginalisation) were identified as positively strong factors associated to Pasifika 'family and community' wellbeing. CONCLUSION: Our study provides new insights on how Pasifika peoples' characteristics and behaviours align to wellbeing. Our findings point to 'family and community' as being the most important wellbeing factor for Pasifika peoples.

Avoidance of Routine Endotracheal Suction in Subjects Ventilated for ≤ 12 Hours Following Elective Cardiac Surgery.

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 [Formula: see text]/[Formula: see text] on room air 6 h after extubation, with a noninferiority margin of 10% (lower bound of one-sided 95% CI to be < 30). RESULTS: There were no differences in group characteristics at baseline. The primary analysis was a per-protocol analysis performed on 154 subjects. The median [Formula: see text]/[Formula: see text] 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 < 12 h after surgery.

Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU).

OBJECTIVE: To determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing. DESIGN: Pragmatic parallel group randomised controlled trial. SETTING: Community-dwelling participants. PARTICIPANTS: People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both). INTERVENTION: Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression. PRIMARY AND SECONDARY OUTCOME MEASURES: Healing 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. RESULTS: We 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%). CONCLUSION: The effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear. TRIAL REGISTRATION NUMBER: NCT02896725.

Adverse event reporting and trial registration in venous leg ulcer trials published since the 2001 CONSORT statement revision: A systematic review.

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.

Study protocol: A randomized controlled trial assessing the avoidance of endotracheal suction in cardiac surgical patients ventilated for ≤ 12 hr.

AIMS: To assess the safety and efficacy of avoiding endotracheal suction in postoperative cardiac surgical patients mechanically ventilated for ≤ 12 hr. DESIGN: 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. METHODS: 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 (PaO2 ) to fraction of inspired oxygen (FiO2 ) (P/F) 6 hr after extubation. Pain assessments will be performed before, during and after endotracheal suction (ETS) and the patient experience will be investigated with a brief interview the following day. Ethics approval was received in October 2015. DISCUSSION: Endotracheal 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. IMPACT: 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.

Rugby Fans in Training New Zealand (RUFIT-NZ): a pilot randomized controlled trial of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand.

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.

Endotracheal suction in intensive care: A point prevalence study of current practice in New Zealand and Australia.

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.

Using codesign to develop a culturally tailored, behavior change mHealth intervention for indigenous and other priority communities: A case study in New Zealand.

The obesity rate in New Zealand is one of the highest worldwide (31%), with highest rates among Maori (47%) and Pasifika (67%). Codesign was used to develop a culturally tailored, behavior change mHealth intervention for Maori 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 Maori 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 Maori 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/whanau [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 Maori 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.

A co-designed mHealth programme to support healthy lifestyles in Maori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial.

BACKGROUND: The OL@-OR@ mobile health programme was co-designed with Maori 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 Maori 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 Maori 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 Maori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Maori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Maori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Maori 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 Maori and Pasifika individuals. FUNDING: Healthier Lives He Oranga Hauora National Science Challenge.

Prescribed Exercise With Compression vs Compression Alone in Treating Patients With Venous Leg Ulcers: A Systematic Review and Meta-analysis.

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.