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.

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.

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.

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, Culturally-Tailored mHealth Tool to Support Healthy Lifestyles in Maori and Pasifika Communities in New Zealand: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: New Zealand urgently requires scalable, effective, behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of Maori and Pasifika communities. OBJECTIVE: The primary objective of this study is to determine the effects of a co-designed, culturally tailored, lifestyle support mHealth tool (the OL@-OR@ mobile phone app and website) on key risk factors and behaviors associated with an increased risk of noncommunicable disease (diet, physical activity, smoking, and alcohol consumption) compared with a control condition. METHODS: A 12-week, community-based, two-arm, cluster-randomized controlled trial will be conducted across New Zealand from January to December 2018. Participants (target N=1280; 64 clusters: 32 Maori, 32 Pasifika; 32 clusters per arm; 20 participants per cluster) will be individuals aged ≥18 years who identify with either Maori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a mobile phone, tablet, laptop, or computer and to the internet. Clusters will be identified by community coordinators and randomly assigned (1:1 ratio) to either the full OL@-OR@ tool or a control version of the app (data collection only plus a weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban, or provincial) for Maori clusters. All participants will provide self-reported data at baseline and at 4- and 12-weeks postrandomization. The primary outcome is adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score at 12 weeks that assesses smoking behavior, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with the OL@-OR@ tool. RESULTS: Trial recruitment opened in January 2018 and will close in July 2018. Trial findings are expected to be available early in 2019. CONCLUSIONS: Currently, there are no scalable, evidence-based tools to support Maori or Pasifika individuals who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster-randomized trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool in supporting healthy lifestyles. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Register ACTRN12617001484336; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx (Archived by WebCite at http://www.webcitation.org/71DX9BsJb). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10789.

Honey as a topical treatment for wounds.

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.

Honey as a topical treatment for wounds.

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 was to determine whether honey increases the rate of healing in acute wounds (e.g. burns, lacerations) and chronic wounds (e.g. skin ulcers, infected surgical wounds). SEARCH METHODS: For this first update of the review we searched the Cochrane Wounds Group Specialised Register (searched 13 June 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 5); Ovid MEDLINE (2008 to May Week 5 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations 12 June 2012); Ovid EMBASE (2008 to 2012 Week 23); and EBSCO CINAHL (2008 to 8 June 2012). 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. MAIN RESULTS: We identified 25 trials (with a total of 2987 participants) that met the inclusion criteria, including six new trials that were added to this update. In acute wounds, three trials evaluated the effect of honey in acute lacerations, abrasions or minor surgical wounds and 12 trials evaluated the effect of honey in burns. In chronic wounds, two trials evaluated the effect of honey in venous leg ulcers, and single trials investigated its effect in infected post-operative wounds, pressure injuries, cutaneous Lieshmaniasis, diabetic foot ulcers and Fournier's gangrene. Three trials recruited people into mixed groups of chronic or acute wounds. Most trials were at high or unclear risk of bias. In acute wounds, specifically partial-thickness burns, honey might reduce time to healing compared with some conventional dressings (WMD -4.68 days, 95%CI -4.28 to -5.09 days), but, when compared with early excision and grafting, honey delays healing in partial- and full-thickness burns (WMD 13.6 days, 95% CI 10.02 to 17.18 days). In chronic wounds, honey does not significantly increase healing in venous leg ulcers when used as an adjuvant to compression (RR 1.15, 95% CI 0.96 to 1.38), and may delay healing in cutaneous Leishmaniasis when used as an adjuvant to meglumine antimoniate compared to meglumine antimoniate alone (RR 0.72, 95% CI 0.51 to 1.01). AUTHORS' CONCLUSIONS: Honey dressings do not increase rates of healing significantly in venous leg ulcers when used as an adjuvant to compression. Honey may delay healing in partial- and full-thickness burns in comparison to early excision and grafting, and in cutaneous Leishmaniasis when used as an adjuvant with meglumine antimoniate. Honey might be superior to some conventional dressing materials, but there is considerable uncertainty about the replicability and applicability of this evidence. There is insufficient evidence to guide clinical practice in other types of wounds, and purchasers should refrain from providing honey dressings for routine use until sufficient evidence of effect is available.

Honey as a topical treatment for wounds.

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 honey may accelerate wound healing. OBJECTIVES: The objective was to determine whether honey increases the rate of healing in acute wounds (burns, lacerations and other traumatic wounds) and chronic wounds (venous ulcers, arterial ulcers, diabetic ulcers, pressure ulcers, infected surgical wounds). SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (May 2008), CENTRAL (May 2008) and several other electronic databases (May 2008). Bibliographies were searched and manufacturers of dressing products were contacted for unpublished trials. 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 using a data extraction sheet by one author and independently verified by a second author. MAIN RESULTS: 19 trials (n=2554) were identified that met the inclusion criteria. In acute wounds, three trials evaluated the effect of honey in acute lacerations, abrasions or minor surgical wounds and nine trials evaluated the effect the honey in burns. In chronic wounds two trials evaluated the effect of honey in venous leg ulcers and one trial in pressure ulcers, infected post-operative wounds, and Fournier's gangrene respectively. Two trials recruited people with mixed groups of chronic or acute wounds. The poor quality of most of the trial reports means the results should be interpreted with caution, except in venous leg ulcers. In acute wounds, honey may reduce time to healing compared with some conventional dressings in partial thickness burns (WMD -4.68 days, 95%CI -4.28 to -5.09 days). All the included burns trials have originated from a single centre, which may have impact on replicability. In chronic wounds, honey in addition to compression bandaging does not significantly increase healing in venous leg ulcers (RR 1.15, 95%CI 0.96 to 1.38). There is insufficient evidence to determine the effect of honey compared with other treatments for burns or in other acute or chronic wound types. AUTHORS' CONCLUSIONS: Honey may improve healing times in mild to moderate superficial and partial thickness burns compared with some conventional dressings. Honey dressings as an adjuvant to compression do not significantly increase leg ulcer healing at 12 weeks. There is insufficient evidence to guide clinical practice in other areas.

Chitosan for overweight or obesity.

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.

Clinical trials in New Zealand--treading water in the knowledge wave?

AIMS: To describe the number and type of clinical trials in New Zealand 1998-2003, and to identify the number of trials for which approval was sought in 2003 that were listed with trial registries. METHODS: Annual reports (1998-2003) from all regional ethics committees were reviewed for clinical trials. Trials must have been referred to as phase I, II, or III clinical trials; employ descriptors such as randomised controlled trials or controlled trials; or been known to the authors as randomised controlled trials. Trials registers at ClinicalTrials.gov, Current Controlled Trials, NHMRC Clinical Trials Centre, National Cancer Research Network, CenterWatch, Trans-Tasman Radiation Oncology Group, as well as industry registers were searched using keyword identifiers for the trials submitted for ethical review in 2003. RESULTS: Ethics approval was sought for 665 clinical trials (1998, 118 trials; 1999, 91 trials; 2000, 103 trials; 2001, 104 trials; 2002, 108 trials; 2003, 141 trials). The majority of applications (481, 72%) were submitted to either the Auckland or Canterbury committees. 581 (87%) applications were for phase III trials. 522 (78%) applications were for trials involving pharmacological agents, and 115 applications (17%) were for trials involving procedures, processes, or medical devices. The remaining 28 applications (4%) involved interventions such as diet, complementary therapies, or dental care. Of all applications, 332 (50%) were in the fields of cancer, cardiovascular disease, and respiratory disease. Only 45 (32%) of the 141 trials submitted for review in 2003 were listed in a public domain register. CONCLUSIONS: The number of randomised controlled trials (RCTs) in New Zealand has not clearly increased in recent years despite the greater than ever need for such evidence. Information currently in the public domain could support registers of clinical trials.