A multiple case study of pre-diabetes care undertaken by general practice in Aotearoa/New Zealand: de-incentivised and de-prioritised work.

BACKGROUND: In Aotearoa/New Zealand (NZ) general practices diagnose and manage pre-diabetes. This work is important as it has the potential to delay or prevent the onset of Type 2 Diabetes (T2DM), reduce NZ's health inequities, and the burden that T2DM places on health care services. However, no study has previously examined how this work routinely occurs in NZ. METHODS: Two case studies of practices serving ethnically and socio-economically diverse populations, followed by cross-case analysis. RESULTS: The NZ health care context including funding mechanisms, reporting targets, and the disease centred focus of care, acted together to dis-incentivise and de-prioritise pre-diabetes care in general practices. The social determinants of health differentially influenced patients' ability to engage with and respond to pre-diabetes care, significantly impacting this work. Differing perspectives about the significance of pre-diabetes and gaps in systematic screening practices were identified. Interventions used were inconsistent and lacked comprehensive ongoing support. CONCLUSIONS: Complex multi-layered factors impact on pre-diabetes care, and many of the barriers cannot be addressed at the general practice level. The practice serving the most disadvantaged population who concurrently have higher rates of pre-diabetes/T2DM were more adversely affected by the barriers identified.

Very low carbohydrate (ketogenic) diets in type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.

AIM: Very low carbohydrate/ketogenic diets (VLC/KDs) are popular but their role in managing pre-diabetes and type 2 diabetes (T2D) is uncertain. This study uses a systematic review and meta-analysis of randomized controlled trials to estimate the effect of these diets in this population. MATERIALS AND METHODS: A systematic review identified randomized controlled trials of at least 6 months duration comparing efficacy and safety of VLC/KDs (≤50 g carbohydrate or ≤10% total energy from carbohydrate per day) with a control diet (carbohydrate above the VLC/KD threshold) in adults with pre-diabetes or T2D. The primary outcome variable was glycated haemoglobin (HbA1c) after 12 months. The meta-analysis method was inverse variance weighting of mean values for continuous variables. RESULTS: Key word searches identified 2290 studies; 2221 were not in scope. A full text review of 69 studies identified eight meeting inclusion criteria; in total, it involved 606 participants. Six studies reported HbA1c (%) at 12 months; four as change from baseline with a fixed effects estimate (95% confidence interval): VLC/KD minus control of 0.01% (-0.22 to 0.25), p = .91; and two as change from baseline: -0.65% (-0.99; -0.31) [-7.1 mmol/mol (-10.8; -3.4)], p < .001. Serum triglycerides were lower with VLC/KD versus control: -0.28 mmol/L (-0.44 to -0.11), p < .001. High-density lipoprotein was higher with an estimate of 0.04 mmol/L (0.01 to 0.08), p = .03, in the five studies reporting 12-month summary data. CONCLUSIONS: A VLC/KD may cause reductions in HbA1c and triglycerides in those with pre-diabetes or T2D but evidence of an advantage over other strategies is limited. More well-designed studies are required to provide certain evidence.

They're sicker than we think: an exploratory study profiling the cardio-metabolic health in a sample of adults with pre-diabetes in Aotearoa New Zealand.

Introduction Type 2 diabetes mellitus (T2DM) is a highly prevalent and potentially preventable condition associated with significant health, social, and economic costs. The detection and management of pre-diabetes is an important opportunity to prevent or delay the onset of T2DM and associated morbidities; however, its importance is controversial as the health risks associated with pre-diabetes are poorly understood. Aim To understand the cardio-metabolic health profile of a sample of adults with pre-diabetes in Aotearoa New Zealand. Methods Secondary analyses of baseline data from all 153 adults recruited to an intervention trial for adults with pre-diabetes were carried out. A profile of cardio-metabolic risk was measured by describing the proportion with metabolic syndrome (MetS) calculated using Adult Treatment Panel III criteria, which includes blood pressure, lipids, and obesity in addition to glycaemic measures. The severity of MetS was calculated as MetS Z-scores. Subgroup analyses for sex, ethnicity and glycated haemoglobin (HbA1c ) were performed. Results Overall, 74% of this study population had MetS, and the proportion varied according to ethnicity and HbA1c level. The severity of MetS was highly variable, with MetS-Z-scores ranging from -1.0 to 2.8. Although mean MetS Z-scores differed according to ethnicity and HbA1c level, all subgroups included individuals with widely differing severity of MetS, suggesting likely quite different risks for progression to diabetes or cardiovascular disease across the range of pre-diabetes defined by HbA1c . Discussion Single biochemical markers of glycaemia are insufficient to ascertain overall cardio-metabolic risk when prioritising clinical efforts for those with pre-diabetes, particularly in primary care, where the potential for preventing or delaying the onset of type 2 diabetes mellitus (T2DM) is significant. Findings indicate the importance of attending to all cardio-metabolic risk factors when caring for people with pre-diabetes. The development of tools using multiple relevant variables and predicting a comprehensive range of outcomes would improve timely risk stratification and treatment effect monitoring of pre-diabetes populations.

Uncertainty and certainty: perceptions and experiences of prediabetes in New Zealand primary care – a qualitative study.

Introduction Prediabetes is the asymptomatic precursor to type two diabetes mellitus, a significant and growing public health problem in New Zealand (NZ). Little is known about how general practitioners (GPs) and nurses view prediabetes care, and similarly little is known about how people with prediabetes view their condition and care. Aim This study aimed to investigate the views of NZ GPs and nurses, and people with prediabetes about prediabetes and its management. Methods This was a mixed qualitative methods study that is part of a randomised control trial of a prediabetes intervention. Results Three key themes emerged from the health professional data (GPs and nurses) and another three themes emerged from people with prediabetes data. GPs and nurses were uncertain about the progression of prediabetes; they felt prediabetes was not a priority and they were unsure about what to advise. People with prediabetes were uncertain about the diagnosis and information given to them; they were unsure about what to do about prediabetes and they found lifestyle change hard. Discussion GPs, nurses and people with prediabetes, expressed much uncertainty, but also some certainty about prediabetes. All were certain that prediabetes is common and increasing and that sustained lifestyle change was very difficult. But uncertainty prevailed about whether, in reality, prediabetes could be stopped, who would be most likely to benefit from lifestyle interventions and how best to achieve these. Older Maori and Pacific women were keen to promote lifestyle change and this appeared best done through Maori and Pacific peoples' organisations by means of co-designed interventions.

A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes.

AIMS: To evaluate the effect of the probiotic Lactobacillus rhamnosus HN001 and/or cereal enriched with oat-derived beta-glucan (OBG) on metabolic and mental health outcomes when administered to adults with pre-diabetes. DESIGN: 2×2 factorial design randomised, parallel-groups placebo-controlled; double-blinded for probiotic, single-blinded for cereals. PARTICIPANTS: Community-dwelling adults aged 18-80 years with pre-diabetes: glycated haemoglobin (HbA1c) 41-49 mmol/mol. INTERVENTIONS: Capsules containing Lactobacillus rhamnosus (HN001) (6×109 colony-forming units/day), or placebo capsules; and cereal containing 4 g/day OBG or calorie-matched control cereal, taken daily, for 6 months. Study groups were: (A) HN001 capsules+OBG cereal; (B) HN001 capsules+control cereal; (C) placebo capsules+OBG cereal and (D) placebo capsules+control cereal. OUTCOME MEASURES: Primary outcome: HbA1c at 6 months. SECONDARY OUTCOMES: fasting plasma glucose, fasting insulin, homeostatic model assessment of insulin resistance, fasting lipids, blood pressure, body weight, waist circumference, body mass index and mental well-being. RESULTS: 153 participants were randomised. There was complete HbA1c outcome data available for 129 participants. At 6 months the mean (SD) HbA1c was 45.9 (4.4) mmol/mol, n=66 for HN001, and 46.7 (4.3) mmol/mol, n=63 for placebo capsules; 46.5 (4.0) mmol/mol, n=67 for OBG and 46.0 (4.6) mmol/mol n=62 for control cereal. The estimated difference between HN001-placebo capsules was -0.83, 95% CI -1.93 to 0.27 mmol/mol, p=0.63, and between OBG-control cereals -0.17, 95% CI -1.28 to 0.94 mmol/mol, p=0.76. There was no significant interaction between treatments p=0.79. There were no differences between groups or significant interactions between treatments for any of the secondary outcomes. CONCLUSIONS: This study found no evidence of clinical benefit from the supplementation with either HN001 and/or cereal containing 4 g OBG on HbA1c and all secondary outcomes relevant to adults with pre-diabetes. TRIAL REGISTRATION NUMBER: Australian New Zealand Clincial Trials Registry number ACTRN12617000990325.

It is time for a more targeted approach to prediabetes in primary care in Aotearoa New Zealand.

Type 2 diabetes (T2DM), its related morbidities and entrenched diabetes-related inequities pose significant challenges for health care delivery systems in Aotearoa New Zealand (NZ). Primary care services undertake the majority of diabetes prevention work by initially detecting and managing those with prediabetes. In this viewpoint, we present available NZ data to highlight NZ trends in prediabetes and consider the current NZ clinical guidelines and the prediabetes care pathway. Multiple areas for improvement are identified to optimise diabetes prevention, potentially reduce T2DM inequities, and sustain more effective prediabetes management in primary care in NZ.

Effect of Lactobacillus rhamnosus Probiotic in Early Pregnancy on Plasma Conjugated Bile Acids in a Randomised Controlled Trial.

We have previously shown that probiotic supplementation with Lactobacillus rhamnosus HN001 (HN001) led to a reduced incidence of gestational diabetes mellitus (GDM). Here we investigate whether HN001 supplementation resulted in alterations in fasting lipids, insulin resistance, or bile acids (BAs) during pregnancy. Fasting plasma samples collected at 24-30 weeks' gestation, from 348 women randomised at 14-16 weeks' gestation to consume daily probiotic HN001 (n = 172) or a placebo (n = 176) were analysed for lipids, insulin, glucose and BAs. Women supplemented with HN001 had lower fasting glucose compared with placebo (p = 0.040), and lower GDM. Significant differences were found in fasting insulin, HOMA-IR, low density lipoprotein-cholesterol (LDL-c), high density lipoprotein (HDL)-c, triglycerides, total cholesterol, and BAs by GDM status. Lower fasting conjugated BAs were seen in women receiving HN001. A significant decrease of glycocholic acid (GCA) was found in older (age ≥ 35) women who received HN001 (p = 0.005), while GDM women showed significant reduced taurodeoxycholic acid (TDCA) (p = 0.018). Fasting conjugated BA was positively correlated with fasting glucose (r = 0.136, p = 0.020) and fasting insulin (r = 0.113, p = 0.036). Probiotic HN001 supplementation decreases conjugated BAs and might play a role in the improvement of glucose metabolism in women with pregnancy.

Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and ß-glucan to improve glycated haemoglobin, metabolic health, and general well-being in adults with pre-diabetes: study protocol for a 2 × 2 factorial design, parallel group, placebo-controlled randomized controlled trial, with embedded qualitative study and economic analysis.

BACKGROUND: The rates of pre-diabetes and type 2 diabetes mellitus are increasing worldwide, producing significant burdens for individuals, families, and healthcare systems. In New Zealand, type 2 diabetes mellitus and pre-diabetes disproportionally affect Maori, Pacific, and South Asian peoples. This research evaluates the efficacy, acceptability, and economic impact of a probiotic capsule and a prebiotic cereal intervention in adults with pre-diabetes on metabolic and mental health and well-being outcomes. METHODS: Eligible adults (n = 152) aged 18-80 years with pre-diabetes (glycated haemoglobin 41-49 mmol/mol) will be enrolled in a 2 × 2 factorial design, randomised, parallel-group, placebo-controlled trial. Computer-generated block randomization will be performed independently. Interventions are capsulated Lactobacillus rhamnosus HN001 (6 × 109 colony-forming units/day) (A) and cereal containing 4 g ß-glucan (B), placebo capsules (O1), and calorie-matched control cereal (O2). Eligible participants will receive 6 months intervention in the following groups: AB, AO1, BO2, and O1O2. The primary outcome is glycated haemoglobin after 6 months. Follow-up at 9 months will assess the durability of response. Secondary outcomes are glycated haemoglobin after 3 and 9 months, fasting glucose, insulin resistance, blood pressure, body weight, body mass index, and blood lipid levels. General well-being and quality of life will be measured by the Short-Form Health Survey 36 and Depression Anxiety Stress Scale 21 at 6 and 9 months. Outcome assessors will be blind to capsule allocation. An accompanying qualitative study will include 24 face-to-face semistructured interviews with an ethnically balanced sample from the ß-glucan arms at 2 months, participant focus groups at 6 months, and three health professional focus groups. These will explore how interventions are adopted, their acceptability, and elicit factors that may support the uptake of interventions. A simulation model of the pre-diabetic New Zealand population will be used to estimate the likely impact in quality-adjusted life years and health system costs of the interventions if rolled out in New Zealand. DISCUSSION: This study will examine the efficacy of interventions in a population with pre-diabetes. Qualitative components provide rich description of views on the interventions. When combined with the economic analysis, the study will provide insights into how to translate the interventions into practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000990325. Prospectively registered on 10 July 2017.

Daily decision-making about food during pregnancy: a New Zealand study.

Pregnancy has always been a life-changing event for women and their families, but societal concern about pregnancy and motherhood has become intense in the digital age. The role of health promotion agencies and others supplying health-related resources about lifestyle behaviours is both important and in need of scrutiny. Ever increasing advice for pregnant women, their families and health professionals, abounds. This study of decision making during pregnancy investigated how women made everyday decisions during pregnancy about food and drink, as well as dietary supplements and medications, alcohol and recreational drugs. This qualitative interview study was a side-arm to a double-blind randomized, placebo-controlled trial conducted with pregnant women in Wellington New Zealand, 2013-2016. Data from interviews with 20 women were analysed using inductive thematic analysis. In relation to decision-making about lifestyle behaviours, five themes emerged-Information about food; Wanted and unwanted advice; Worry, anxiety and indecision; Making daily decisions about food; Changes in decision making over time. Participating women talked more about food selection and restriction advice than any other lifestyle topic. Analysis demonstrated concern about information accuracy and overload from multiple, diverse sources. Women described learning how to assess resource credibility, how to develop decision-making skills, and who to trust. The study raises important questions about how the health information environment, despite best intentions, can be confusing or potentially harmful. The study underlines the continued importance of the role health professionals have in not only interpreting information to discuss individualized advice, but also in empowering pregnant women to develop lifestyle-related decision-making skills.

Effects of Lactobacillus rhamnosus HN001 in early life on the cumulative prevalence of allergic disease to 11 years.

BACKGROUND: In a two-centre randomized placebo-controlled trial of Lactobacillus rhamnosus HN001 (HN001) (6 × 109 colony-forming units [cfu]) or Bifidobacterium lactis HN019 (HN019) (9 × 109 cfu) taken daily from 35-week gestation to 6 months' post-partum in mothers while breastfeeding and from birth to age 2 years in infants, we showed that HN001 significantly protected against eczema development at 2, 4 and 6 years and atopic sensitization at 6 years. There was no effect of HN019. We report here the findings for 11 year outcomes. METHODS: At age 11 years, eczema was defined as previously using the UK Working Party's Diagnostic Criteria. Asthma, wheeze, hay fever and rhinitis were defined based on the International Study of Asthma and Allergies in Childhood (ISAAC) questions. Atopic sensitization was defined as one or more positive responses (mean wheal diameter ≥3 mm) to a panel of food and aeroallergens. Analysis was intention-to-treat using hazard ratios to assess probiotic effects on the 11-year lifetime prevalence and relative risks for point or 12-month prevalence at 11 years. RESULTS: Early childhood HN001 supplementation was associated with significant reductions in the 12-month prevalence of eczema at age 11 years (relative risk [RR] = 0.46, 95% CI 0.25-0.86, P = 0.015) and hay fever (RR = 0.73, 95% CI 0.53-1.00, P = 0.047). For the lifetime prevalence, HN001 was associated with a significant reduction in atopic sensitization (hazard ratio [HR] = 0.71, 95% CI 0.51-1.00, P = 0.048), eczema (HR = 0.58, 95% CI 0.41-0.82, P = 0.002) and wheeze (HR = 0.76, 95% CI 0.57-0.99, P = 0.046). HN019 had no significant effect on these outcomes. CONCLUSION: This is the first early probiotic intervention to show positive outcomes for at least the first decade of life across the spectrum of allergic disease.

Maternal supplementation alone with Lactobacillus rhamnosus HN001 during pregnancy and breastfeeding does not reduce infant eczema.

BACKGROUND: In a randomized placebo-controlled trial, we previously found that the probiotic Lactobacillus rhamnosus HN001 (HN001) taken by mothers from 35 weeks of gestation until 6 months post-partum if breastfeeding and their child from birth to age 2 years halved the risk of eczema during the first 2 years of life. We aimed to test whether maternal supplementation alone is sufficient to reduce eczema and compare this to our previous study when both the mother and their child were supplemented. METHODS: In this 2-centre, parallel double-blind, randomized placebo-controlled trial, the same probiotic as in our previous study (HN001, 6 × 109 colony-forming units) was taken daily by mothers from 14-16 weeks of gestation till 6 months post-partum if breastfeeding, but was not given directly to the child. Women were recruited from the same study population as the first study, where they or their partner had a history of treated asthma, eczema or hay fever. RESULTS: Women were randomized to HN001 (N = 212) or placebo (N = 211). Maternal-only HN001 supplementation did not significantly reduce the prevalence of eczema, SCORAD ≥ 10, wheeze or atopic sensitization in the infant by 12 months. This contrasts with the mother and child intervention study, where HN001 was associated with reductions in eczema (hazard ratio (HR): 0.39, 95% CI 0.19-0.79, P = .009) and SCORAD (HR = 0.61, 95% 0.37-1.02). However, differences in the HN001 effect between studies were not significant. HN001 could not be detected in breastmilk from supplemented mothers, and breastmilk TGF-ß/IgA profiles were unchanged. CONCLUSION: Maternal probiotic supplementation without infant supplementation may not be effective for preventing infant eczema.

The experiences of pregnant women in an interventional clinical trial: Research In Pregnancy Ethics (RIPE) study.

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial component to ensuring effective recruitment. The Research In Pregnancy Ethics (RIPE) study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington (New Zealand) while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage.

Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial.

The study aims to assess whether supplementation with the probiotic Lactobacillus rhamnosus HN001 (HN001) can reduce the prevalence of gestational diabetes mellitus (GDM). A double-blind, randomised, placebo-controlled parallel trial was conducted in New Zealand (NZ) (Wellington and Auckland). Pregnant women with a personal or partner history of atopic disease were randomised at 14-16 weeks' gestation to receive HN001 (6×109 colony-forming units) (n 212) or placebo (n 211) daily. GDM at 24-30 weeks was assessed using the definition of the International Association of Diabetes and Pregnancy Study Groups (IADPSG) (fasting plasma glucose ≥5·1 mmol/l, or 1 h post 75 g glucose level at ≥10 mmol/l or at 2 h ≥8·5 mmol/l) and NZ definition (fasting plasma glucose ≥5·5 mmol/l or 2 h post 75 g glucose at ≥9 mmol/l). All analyses were intention-to-treat. A total of 184 (87 %) women took HN001 and 189 (90 %) women took placebo. There was a trend towards lower relative rates (RR) of GDM (IADPSG definition) in the HN001 group, 0·59 (95 % CI 0·32, 1·08) (P=0·08). HN001 was associated with lower rates of GDM in women aged ≥35 years (RR 0·31; 95 % CI 0·12, 0·81, P=0·009) and women with a history of GDM (RR 0·00; 95 % CI 0·00, 0·66, P=0·004). These rates did not differ significantly from those of women without these characteristics. Using the NZ definition, GDM prevalence was significantly lower in the HN001 group, 2·1 % (95 % CI 0·6, 5·2), v. 6·5 % (95 % CI 3·5, 10·9) in the placebo group (P=0·03). HN001 supplementation from 14 to 16 weeks' gestation may reduce GDM prevalence, particularly among older women and those with previous GDM.

The Probiotics in Pregnancy Study (PiP Study): rationale and design of a double-blind randomised controlled trial to improve maternal health during pregnancy and prevent infant eczema and allergy.

BACKGROUND: Worldwide there is increasing interest in the manipulation of human gut microbiota by the use of probiotic supplements to modify or prevent a range of communicable and non-communicable diseases. Probiotic interventions administered during pregnancy and breastfeeding offer a unique opportunity to influence a range of important maternal and infant outcomes. The aim of the Probiotics in Pregnancy Study (PiP Study) is to assess if supplementation by the probiotic Lactobacillus rhamnosus HN001 administered to women from early pregnancy and while breastfeeding can reduce the rates of infant eczema and atopic sensitisation at 1 year, and maternal gestational diabetes mellitus, bacterial vaginosis and Group B Streptococcal vaginal colonisation before birth, and depression and anxiety postpartum. METHODS/DESIGN: The PiP Study is a two-centre, randomised, double-blind placebo-controlled trial in Wellington and Auckland, New Zealand. Four hundred pregnant women expecting infants at high risk of allergic disease will be enrolled in the study at 14-16 weeks gestation and randomised to receive either Lactobacillus rhamnosus HN001 (6 × 10(9) colony-forming units per day (cfu/day)) or placebo until delivery and then continuing until 6 months post-partum, if breastfeeding. Primary infant outcomes are the development and severity of eczema and atopic sensitisation in the first year of life. Secondary outcomes are diagnosis of maternal gestational diabetes mellitus, presence of bacterial vaginosis and vaginal carriage of Group B Streptococcus (at 35-37 weeks gestation). Other outcome measures include maternal weight gain, maternal postpartum depression and anxiety, infant birth weight, preterm birth, and rate of caesarean sections. A range of samples including maternal and infant faecal samples, maternal blood samples, cord blood and infant cord tissue samples, breast milk, infant skin swabs and infant buccal swabs will be collected for the investigation of the mechanisms of probiotic action. DISCUSSION: The study will investigate if mother-only supplementation with Lactobacillus rhamnosus HN001 in pregnancy and while breastfeeding can reduce rates of eczema and atopic sensitisation in infants by 1 year, and reduce maternal rates of gestational diabetes mellitus, bacterial vaginosis, vaginal carriage of Group B Streptococcus before birth and maternal depression and anxiety postpartum. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registration: ACTRN12612000196842. Date Registered: 15/02/12.

Differential effects of two probiotics on the risks of eczema and atopy associated with single nucleotide polymorphisms to Toll-like receptors.

BACKGROUND: There is strong evidence to support a genetic predisposition to eczema and more recently studies have suggested that probiotics might be used to prevent eczema by modifying the expression of putative allergy-associated genes. The aim of this present study was to investigate whether two probiotics, Lactobacillus rhamnosus HN001 (HN001) and Bifidobacterium animalis subsp. lactis HN019 (HN019), can modify the known genetic predisposition to eczema conferred by genetic variation in the Toll-like receptor (TLR) genes in a high-risk infant population. METHODS: We selected 54 SNPs in the Toll-like receptor genes. These SNPs were analysed in 331 children of sole European ancestry as part of a double-blind, randomized, placebo-controlled trial examining the effects of HN001 and HN019 supplementation on eczema development and atopic sensitization. RESULTS: The data showed that 26 TLR SNPs interacted with HN001 resulting in a significantly reduced risk of eczema, 18 for eczema severity as defined by SCORAD ≥ 10 and 20 for atopic sensitization compared to placebo. There were only two SNPs that interacted with HN019 resulting in a reduced risk of eczema, eczema severity or atopy. CONCLUSIONS: This is the first study to show that the negative impact of specific TLR genotypes may be positively affected by probiotic supplementation. HN001 exhibits a much stronger effect than HN019 in this respect.

Researching in the community: the value and contribution of nurses to community based or primary health care research.

AIM: To describe the role, contribution and value of research nurses in New Zealand community-based or primary health care research. BACKGROUND: Research nurses are increasingly recognised as having a key role in undertaking successful research in hospitals and clinical trial units however only limited work has been undertaken to examine their role in community-based research. Undertaking health research in the community has unique challenges particularly in relation to research design and recruitment and retention of participants. METHODS: We describe four community-based research projects involving research nurses, each with particular recruitment, retention and logistical problems. Vignettes are used to illustrate the role, contribution and value of research nurses in a diverse range of community research projects. FINDINGS: The knowledge and skills used by research nurses in these projects included familiarity with communities, cultural competence, health care systems and practice philosophies and in particular with vulnerable populations. Their research actions and activities include competence with a broad range of research methodologies, organisational efficiency, family-centred approach, along with advocacy and flexibility. These are underpinned by nursing knowledge and clinical expertise contributing to an ability to work autonomously. These four projects demonstrate that research nurses in community-based research possess specific attributes which facilitate successful study development, implementation and outcome.

To be involved or not: factors that influence nurses' involvement in providing treatment decisional support in advanced cancer.

Decisional support is a multifaceted process of facilitating patients' decision making regarding treatment choices. Effective decisional support practices of nurses in relation to the use of anticancer therapies in patients with advanced disease are central to quality cancer care. A recent qualitative descriptive study (n=21) exploring the decision making practices of doctors and nurses in one tertiary cancer centre in New Zealand identified many complexities associated with nurses and their participation in decisional support. The study revealed that cancer nurses had varied opinions about the meaning and importance of their roles in treatment related decision making. This variation was significant and led the researchers to undertake a detailed secondary exploration of factors that impacted on the nurses' involvement in the provision of decisional support. Four key groups of factors were identified. These were factors relating to degree of knowledge, level of experience, beliefs and understandings about nursing roles and cancer therapies, and structural interfaces in the work setting. Understanding these factors is important because it allows modification of the conditions which impact on the ability to provide effective decisional care. It also provides some understanding of clinical drivers associated with nurses' decisional support work with patients who have advanced cancer.