Impact of preconception and antenatal supplementation with myo-inositol, probiotics, and micronutrients on offspring BMI and weight gain over the first 2 years.

BACKGROUND: Nutritional intervention preconception and throughout pregnancy has been proposed as an approach to promoting healthy postnatal weight gain in the offspring but few randomised trials have examined this. METHODS: Measurements of weight and length were obtained at multiple time points from birth to 2 years among 576 offspring of women randomised to receive preconception and antenatally either a supplement containing myo-inositol, probiotics, and additional micronutrients (intervention) or a standard micronutrient supplement (control). We examined the influence on age- and sex-standardised BMI at 2 years (WHO standards, adjusting for study site, sex, maternal parity, smoking and pre-pregnancy BMI, and gestational age), together with the change in weight, length, BMI from birth, and weight gain trajectories using latent class growth analysis. RESULTS: At 2 years, there was a trend towards lower mean BMI among intervention offspring (adjusted mean difference [aMD] - 0.14 SD [95% CI 0.30, 0.02], p = 0.09), and fewer had a BMI > 95th percentile (i.e. > 1.65 SD, 9.2% vs 18.0%, adjusted risk ratio [aRR] 0.51 [95% CI 0.31, 0.82], p = 0.006). Longitudinal data revealed that intervention offspring had a 24% reduced risk of experiencing rapid weight gain > 0.67 SD in the first year of life (21.9% vs 31.1%, aRR 0.76 [95% CI 0.58, 1.00], p = 0.047). The risk was likewise decreased for sustained weight gain > 1.34 SD in the first 2 years of life (7.7% vs 17.1%, aRR 0.55 [95% CI 0.34, 0.88], p = 0.014). From five weight gain trajectories identified, there were more intervention offspring in the "normal" weight gain trajectory characterised by stable weight SDS around 0 SD from birth to 2 years (38.8% vs 30.1%, RR 1.29 [95% CI 1.03, 1.62], p = 0.029). CONCLUSIONS: Supplementation with myo-inositol, probiotics, and additional micronutrients preconception and in pregnancy reduced the incidence of rapid weight gain and obesity at 2 years among offspring. Previous reports suggest these effects will likely translate to health benefits, but longer-term follow-up is needed to evaluate this. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02509988 (Universal Trial Number U1111-1171-8056). Registered on 16 July 2015.

Higher early pregnancy plasma myo-inositol associates with increased postprandial glycaemia later in pregnancy: Secondary analyses of the NiPPeR randomized controlled trial.

AIM: Myo-inositol supplementation from ~13 weeks' gestation reportedly improves glycaemia regulation in metabolically at-risk women, with speculation that earlier supplementation might bring further improvement. However, the NiPPeR trial of a myo-inositol-containing supplement starting preconception did not lower gestational glycaemia in generally healthy women. We postulated that the earlier timing of supplementation influences the maternal metabolic adaptation for gestational glycaemia regulation. METHODS: In total, 585 women were recruited from Singapore, UK and New Zealand for the NiPPeR study. We examined associations of plasma myo-inositol concentrations at 7 and 28 weeks' gestation with 28 weeks plasma glucose (PG; fasting, and 1 h and 2 h in 75 g oral glucose tolerance test) and insulin indices using linear regression adjusting for covariates. RESULTS: Higher 7-week myo-inositol, but not 28-week myo-inositol, associated with higher 1 h PG [ßadj (95% confidence intervals) 0.05 (0.01, 0.09) loge mmol/L per loge µmol/L, p = .022] and 2 h PG [0.08 (0.03, 0.12), p = .001]; equivalent to 0.39 mmol/L increase in 2 h PG for an average 7-week myo-inositol increase of 23.4 µmol/L with myo-inositol supplementation. Higher 7-week myo-inositol associated with a lower 28-week Stumvoll index (first phase), an approximation of insulin secretion [-0.08 (-0.15, -0.01), p = .020] but not with 28-week Matsuda insulin sensitivity index. However, the clinical significance of a 7-week myo-inositol-related increase in glycaemia was limited as there was no association with gestational diabetes risk, birthweight and cord C-peptide levels. In-silico modelling found higher 28-week myo-inositol was associated with lower gestational glycaemia in White, but not Asian, women after controlling for 7-week myo-inositol effects. CONCLUSION: To our knowledge, our study provides the first evidence that increasing first trimester plasma myo-inositol may slightly exacerbate later pregnancy post-challenge glycaemia, indicating that the optimal timing for starting prenatal myo-inositol supplementation needs further investigation.

Hauora Maori - Maori health: a right to equal outcomes in primary care.

BACKGROUND: For more than a century, Maori have experienced poorer health than non-Maori. In 2019 an independent Tribunal found the Government had breached Te Tiriti o Waitangi by "failing to design and administer the current primary health care system to actively address persistent Maori health inequities". Many Maori (44%) have unmet needs for primary care. Seven models of primary care were identified by the funders and the research team, including Maori-owned practices. We hypothesised patient health outcomes for Maori would differ between models of care. METHODS: Cross-sectional primary care data were analysed at 30 September 2018. National datasets were linked to general practices at patient level, to measure associations between practice characteristics and patient health outcomes. PRIMARY OUTCOMES: polypharmacy (≥ 55 years), HbA1c testing, child immunisations, ambulatory sensitive hospitalisations (0-14, 45-64 years) and emergency department attendances. Regressions include only Maori patients, across all models of care. RESULTS: A total of 660,752 Maori patients were enrolled in 924 practices with 124,854 in 65 Maori-owned practices. Maori practices had: no significant association with HbA1c testing, ambulatory sensitive hospitalisations or ED attendances, and a significant association with lower polypharmacy (3.7% points) and lower childhood immunisations (13.4% points). Maori practices had higher rates of cervical smear and cardiovascular risk assessment, lower rates of HbA1c tests, and more nurse (46%) and doctor (8%) time (FTE) with patients. The average Maori practice had 52% Maori patients compared to 12% across all practices. Maori practices enrolled a higher percentage of children and young people, five times more patients in high deprivation areas, and patients with more multimorbidity. More Maori patients lived rurally (21.5% vs 15%), with a greater distance to the nearest ED. Maori patients were more likely to be dispensed antibiotics or tramadol. CONCLUSIONS: Maori practices are an expression of autonomy in the face of enduring health system failure. Apart from lower immunisation rates, health outcomes were not different from other models of care, despite patients having higher health risk profiles. Across all models, primary care need was unmet for many Maori, despite increased clinical input. Funding must support under-resourced Maori practices and ensure accountability for the health outcomes of Maori patients in all models of general practice.

Maternal B-vitamin and vitamin D status before, during, and after pregnancy and the influence of supplementation preconception and during pregnancy: Prespecified secondary analysis of the NiPPeR double-blind randomized controlled trial.

BACKGROUND: Maternal vitamin status preconception and during pregnancy has important consequences for pregnancy outcome and offspring development. Changes in vitamin status from preconception through early and late pregnancy and postpartum have been inferred from cross-sectional data, but longitudinal data on vitamin status from preconception throughout pregnancy and postdelivery are sparse. As such, the influence of vitamin supplementation on vitamin status during pregnancy remains uncertain. This study presents one prespecified outcome from the randomized controlled NiPPeR trial, aiming to identify longitudinal patterns of maternal vitamin status from preconception, through early and late pregnancy, to 6 months postdelivery, and determine the influence of vitamin supplementation. METHODS AND FINDINGS: In the NiPPeR trial, 1,729 women (from the United Kingdom, Singapore, and New Zealand) aged 18 to 38 years and planning conception were randomized to receive a standard vitamin supplement (control; n = 859) or an enhanced vitamin supplement (intervention; n = 870) starting in preconception and continued throughout pregnancy, with blinding of participants and research staff. Supplement components common to both treatment groups included folic acid, ß-carotene, iron, calcium, and iodine; components additionally included in the intervention group were riboflavin, vitamins B6, B12, and D (in amounts available in over-the-counter supplements), myo-inositol, probiotics, and zinc. The primary outcome of the study was glucose tolerance at 28 weeks' gestation, measured by oral glucose tolerance test. The secondary outcome reported in this study was the reduction in maternal micronutrient insufficiency in riboflavin, vitamin B6, vitamin B12, and vitamin D, before and during pregnancy. We measured maternal plasma concentrations of B-vitamins, vitamin D, and markers of insufficiency/deficiency (homocysteine, hydroxykynurenine-ratio, methylmalonic acid) at recruitment, 1 month after commencing intervention preconception, in early pregnancy (7 to 11 weeks' gestation) and late pregnancy (around 28 weeks' gestation), and postdelivery (6 months after supplement discontinuation). We derived standard deviation scores (SDS) to characterize longitudinal changes among participants in the control group and measured differences between the 2 groups. At recruitment, the proportion of patients with marginal or low plasma status was 29.2% for folate (<13.6 nmol/L), 7.5% and 82.0% for riboflavin (<5 nmol/L and ≤26.5 nmol/L, respectively), 9.1% for vitamin B12 (<221 pmol/L), and 48.7% for vitamin D (<50 nmol/L); these proportions were balanced between the groups. Over 90% of all participants had low or marginal status for one or more of these vitamins at recruitment. Among participants in the control group, plasma concentrations of riboflavin declined through early and late pregnancy, whereas concentrations of 25-hydroxyvitamin D were unchanged in early pregnancy, and concentrations of vitamin B6 and B12 declined throughout pregnancy, becoming >1 SDS lower than baseline by 28 weeks gestation. In the control group, 54.2% of participants developed low late-pregnancy vitamin B6 concentrations (pyridoxal 5-phosphate <20 nmol/L). After 1 month of supplementation, plasma concentrations of supplement components were substantially higher among participants in the intervention group than those in the control group: riboflavin by 0.77 SDS (95% CI 0.68 to 0.87, p < 0.0001), vitamin B6 by 1.07 SDS (0.99 to 1.14, p < 0.0001), vitamin B12 by 0.55 SDS (0.46 to 0.64, p < 0.0001), and vitamin D by 0.51 SDS (0.43 to 0.60, p < 0.0001), with higher levels in the intervention group maintained during pregnancy. Markers of vitamin insufficiency/deficiency were reduced in the intervention group, and the proportion of participants with vitamin D insufficiency (<50 nmol/L) during late pregnancy was lower in the intervention group (35.1% versus 8.5%; p < 0.0001). Plasma vitamin B12 remained higher in the intervention group than in the control group 6 months postdelivery (by 0.30 SDS (0.14, 0.46), p = 0.0003). The main limitation is that generalizability to the global population is limited by the high-resource settings and the lack of African and Amerindian women in particular. CONCLUSIONS: Over 90% of the trial participants had marginal or low concentrations of one or more of folate, riboflavin, vitamin B12, or vitamin D during preconception, and many developed markers of vitamin B6 deficiency in late pregnancy. Preconception/pregnancy supplementation in amounts available in over-the-counter supplements substantially reduces the prevalence of vitamin deficiency and depletion markers before and during pregnancy, with higher maternal plasma vitamin B12 maintained during the recommended lactational period. TRIAL REGISTRATION: ClinicalTrials.gov NCT02509988; U1111-1171-8056.

Is there equity of patient health outcomes across models of general practice in Aotearoa New Zealand? A national cross-sectional study.

BACKGROUND: Primary care in Aotearoa New Zealand is largely delivered by general practices, heavily subsidised by government. Te Tiriti o Waitangi (1840) guarantees equal health outcomes for Maori and non-Maori, but differences are stark and longstanding. Seven models of primary care have evolved. We hypothesised that patient health outcomes would differ between models of care; and that Maori, Pacific peoples and those living in material deprivation would have poorer outcomes from primary care. METHODS: We conducted a cross-sectional study of patient-level data from national datasets and practices, at 30 September 2018, using multilevel mixed effects regression analyses (patients clustered within practices). Primary outcomes, considered to be measures of unmet need for primary care, were polypharmacy (≥ 65 years), HbA1c testing in adults with diabetes, childhood immunisations (6 months), ambulatory sensitive hospitalisations (0-14, 45-64 years) and emergency department attendances. Explanatory variables adjusted for patient and practice characteristics. Equity, by model of care, ethnicity and deprivation, was assumed if they showed no significant association with patient outcomes. Patient characteristics included: age, ethnicity, deprivation, multi-morbidity, first specialist assessments and practice continuity. Practice characteristics included: size, funding and doctor continuity. Clinical input (consultations and time with nurses and doctors) was considered a measure of practice response. RESULTS: The study included 924 general practices with 4,491,964 enrolled patients. Traditional practices enrolled 73% of the population, but, on average, the proportion of Maori, Pacific and people living with material deprivation was low in any one Traditional practice. Patients with high health needs disproportionately enrolled in Maori, Pacific and Trust/NGO practices. There were multiple associations between models of care and patient health outcomes in fully adjusted regressions. No one model of care out-performed others across all outcomes. Patients with higher health need received more clinical input but this was insufficient to achieve equity in all outcomes. Being a Maori or Pacific patient, or living in material deprivation, across models of care, remained associated with poorer outcomes. CONCLUSIONS: Model-level associations with poor patient outcomes suggest inequity in measures that might be used to target investment in primary care.

Impact of age at type 2 diabetes mellitus diagnosis on mortality and vascular complications: systematic review and meta-analyses.

AIMS/HYPOTHESIS: Few studies examine the association between age at diagnosis and subsequent complications from type 2 diabetes. This paper aims to summarise the risk of mortality, macrovascular complications and microvascular complications associated with age at diagnosis of type 2 diabetes. METHODS: Data were sourced from MEDLINE and All EBM (Evidence Based Medicine) databases from inception to July 2018. Observational studies, investigating the effect of age at diabetes diagnosis on macrovascular and microvascular diabetes complications in adults with type 2 diabetes were selected according to pre-specified criteria. Two investigators independently extracted data and evaluated all studies. If data were not reported in a comparable format, data were obtained from authors, presented as minimally adjusted ORs (and 95% CIs) per 1 year increase in age at diabetes diagnosis, adjusted for current age for each outcome of interest. The study protocol was recorded with PROSPERO International Prospective Register of Systematic Reviews (CRD42016043593). RESULTS: Data from 26 observational studies comprising 1,325,493 individuals from 30 countries were included. Random-effects meta-analyses with inverse variance weighting were used to obtain the pooled ORs. Age at diabetes diagnosis was inversely associated with risk of all-cause mortality and macrovascular and microvascular disease (all p < 0.001). Each 1 year increase in age at diabetes diagnosis was associated with a 4%, 3% and 5% decreased risk of all-cause mortality, macrovascular disease and microvascular disease, respectively, adjusted for current age. The effects were consistent for the individual components of the composite outcomes (all p < 0.001). CONCLUSIONS/INTERPRETATION: Younger, rather than older, age at diabetes diagnosis was associated with higher risk of mortality and vascular disease. Early and sustained interventions to delay type 2 diabetes onset and improve blood glucose levels and cardiovascular risk profiles of those already diagnosed are essential to reduce morbidity and mortality. Graphical abstract.

Evaluating Glomerular Filtration Rate Slope as a Surrogate End Point for ESKD in Clinical Trials: An Individual Participant Meta-Analysis of Observational Data.

BACKGROUND: Decline in eGFR is a biologically plausible surrogate end point for the progression of CKD in clinical trials. However, it must first be tested to ensure strong associations with clinical outcomes in diverse populations, including patients with higher eGFR. METHODS: To investigate the association between 1-, 2-, and 3-year changes in eGFR (slope) with clinical outcomes over the long term, we conducted a random effects meta-analysis of 3,758,551 participants with baseline eGFR≥60 ml/min per 1.73 m2 and 122,664 participants with eGFR<60 ml/min per 1.73 m2 from 14 cohorts followed for an average of 4.2 years. RESULTS: Slower eGFR decline by 0.75 ml/min per 1.73 m2 per year over 2 years was associated with lower risk of ESKD in participants with baseline eGFR≥60 ml/min per 1.73 m2 (adjusted hazard ratio, 0.70; 95% CI, 0.68 to 0.72) and eGFR<60 ml/min per 1.73 m2 (0.71; 95% CI, 0.68 to 0.74). The relationship was stronger with 3-year slope. For a rapidly progressing population with predicted 5-year risk of ESKD of 8.3%, an intervention that reduced eGFR decline by 0.75 ml/min per 1.73 m2 per year over 2 years would reduce the ESKD risk by 1.6%. For a hypothetical low-risk population with a predicted 5-year ESKD risk of 0.58%, the same intervention would reduce the risk by only 0.13%. CONCLUSIONS: Slower decline in eGFR was associated with lower risk of subsequent ESKD, even in participants with eGFR≥60 ml/min per 1.73 m2, but those with the highest risk would be expected to benefit the most.

Understandings of disease among Pacific peoples with diabetes and end-stage renal disease in New Zealand.

BACKGROUND: Compared with New Zealand Europeans, Pacific peoples in New Zealand develop type 2 diabetes at a higher rate and a younger age, and have 3.8 times higher incidence of end-stage renal disease (ESRD). OBJECTIVE: To investigate contextual factors that shape understandings of disease for Pacific peoples with diabetes and ESRD. METHODS: Focussed ethnography. In-depth interviews were conducted with 16 Pacific people on haemodialysis for diabetic ESRD, in Auckland, New Zealand. Study participants aged between 30 and 69 years old were of Samoan, Cook Islander, Tongan, Niuean or Tokelauan ethnicity. Thematic analysis was used to code and identify themes. RESULTS: Participants were embedded in a multigenerational legacy of diabetes. The limited diabetes-related education of earlier generations influenced how future generations behaved and understood diabetes. Perceptions were compounded by additional factors including the invisibility of early-stage diabetes; misunderstandings of health risks during communication with health providers; and misunderstandings of multiple conditions' symptoms and management. Participants had limited engagement with health services until their diagnosis of ESRD acted as a trigger to change this behaviour. However, this trigger was not effective in itself-rather, it was in combination with relevant education delivered in a way that made sense to participants, given their current understandings. CONCLUSIONS: Illness representations drive choices and behaviours with respect to self-management of diabetes and engagement with health services. Diabetes is often present in multiple generations of Pacific people; therefore, illness representations are developed and shared within a family. Changing illness representations requires engagement with the individual within a family context.

How does it feel to be a problem? Patients' experiences of self-management support in New Zealand and Canada.

BACKGROUND: The impact of long-term conditions is the "healthcare equivalent to climate change." People with long-term conditions often feel they are a problem, a burden to themselves, their family and friends. Providers struggle to support patients to self-manage. The Practical Reviews in Self-Management Support (PRISMS) taxonomy lists what provider actions might support patient self-management. OBJECTIVE: To offer providers advice on how to support patient self-management. DESIGN: Semi-structured interviews with 40 patient-participants. SETTING AND PARTICIPANTS: Three case studies of primary health-care organizations in New Zealand and Canada serving diverse populations. Participants were older adults with long-term conditions who needed support to live in the community. MAIN OUTCOME MEASURES: Qualitative description to classify patient narratives of self-management support according to the PRISMS taxonomy with thematic analysis to explore how support was acceptable and effective. RESULTS: Patients identified a relationship-in-action as the mechanism, the how by which providers supported them to self-manage. When providers acted upon knowledge of patient lives and priorities, these patients were often willing to try activities or medications they had resisted in the past. Effective self-management support saw PRISMS components delivered in patient-specific combinations by individual providers or teams. DISCUSSION AND CONCLUSIONS: Providers who establish relationships with patients can support them to self-manage and improve health outcomes. Delivery of taxonomy components, in the absence of a relationship, is unlikely to be either acceptable or effective. Providers need to be aware that social determinants of health can constrain patients' options to self-manage.

Mechanisms, contexts and points of contention: operationalizing realist-informed research for complex health interventions.

BACKGROUND: The concept of "mechanism" is central to realist approaches to research, yet research teams struggle to operationalize and apply the concept in empirical research. Our large, interdisciplinary research team has also experienced challenges in making the concept useful in our study of the implementation of models of integrated community-based primary health care (ICBPHC) in three international jurisdictions (Ontario and Quebec in Canada, and in New Zealand). METHODS: In this paper we summarize definitions of mechanism found in realist methodological literature, and report an empirical example of a realist analysis of the implementation ICBPHC. RESULTS: We use our empirical example to illustrate two points. First, the distinction between contexts and mechanisms might ultimately be arbitrary, with more distally located mechanisms becoming contexts as research teams focus their analytic attention more proximally to the outcome of interest. Second, the relationships between mechanisms, human reasoning, and human agency need to be considered in greater detail to inform realist-informed analysis; understanding these relationships is fundamental to understanding the ways in which mechanisms operate through individuals and groups to effect the outcomes of complex health interventions. CONCLUSIONS: We conclude our paper with reflections on human agency and outline the implications of our analysis for realist research and realist evaluation.

A brief campaign to prevent diabetic ketoacidosis in children newly diagnosed with type 1 diabetes mellitus: The NO-DKA Study.

OBJECTIVE: New-onset diabetic ketoacidosis (NO-DKA) is entirely preventable with early recognition of the symptoms of type 1 diabetes mellitus (T1D). In this study, we aimed to assess whether a simple and easily delivered educational campaign could reduce the risk of DKA. METHODS: A poster highlighting key features of new-onset T1D was delivered once a year over 2 years to mailboxes of over 460 000 individual residential households in the Auckland region (New Zealand). In the first year, the campaign poster was also delivered to all general practices in the region. Families of all newly diagnosed cases of T1D in children answered a brief questionnaire to ascertain whether the campaign reached them. RESULTS: Over the 24-month period covered by this study, 132 new cases of T1D were diagnosed in children and adolescents in Auckland. There were 38 cases (28.8%) of DKA, which is similar to the average over the previous 5-year period (27.0%). The caregivers of three children reported both seeing the campaign poster and seeking medical attention as a result. None of these three children were in DKA at diagnosis; they were aged 6.3 to 9.7 years, and of New Zealand European ethnicity. CONCLUSIONS: A non-targeted campaign to raise awareness of diabetes symptoms in youth led only a few caregivers to seek timely medical attention. Overall, this once-yearly untargeted campaign to raise awareness of diabetes symptoms in youth had limited impact. More effective strategies are required, possibly involving sustained targeted education of medical practitioners.

Should we embed randomized controlled trials within action research: arguing from a case study of telemonitoring.

BACKGROUND: Action research (AR) and randomized controlled trials (RCTs) are usually considered to be theoretically and practically incompatible. However, we argue that their respective strengths and weaknesses can be complementary. We illustrate our argument from a recent study assessing the effect of telemonitoring on health-related quality of life, self-care, hospital use, costs and the experiences of patients, informal carers and health care professionals in two urban hospital services and one remote rural primary care service in New Zealand. METHODS: Data came from authors' observations and field notes of discussions with three groups: the healthcare providers and healthcare consumers who participated in the research, and a group of 17 researchers and collaborators. The consumers had heart failure (Site A, urban), airways disease (Site B, urban), and diabetes (Site C, rural). The research ran from 2008 (project inception) until 2012 (project close-off). Researchers came from a wide range of disciplines. Both RCT and AR methods were recognised from early in the process but often worked in parallel rather than together. In retrospect, we have mapped our observed research processes to the AR cycle characteristics (creation of communicative space, democracy and participation, iterative learning and improvement, emergence, and accommodation of different ways of knowing). RESULTS: We describe the context, conduct and outcomes of the telemonitoring trial, framing the overall process in the language of AR. Although not fully articulated at the time, AR processes made the RCT sensitive to important context, e.g. clinical processes. They resulted in substantive changes to the design and conduct of the RCT, and to interpretation and uptake of findings, e.g. a simpler technology procurement process emerged. Creating a communicative space enabled co-design between the researcher group and collaborators from the provider participant group, and a stronger RCT design. CONCLUSIONS: It appears possible to enhance the utility of RCTs by explicitly embedding them in an AR framework to shape stronger RCT design. The AR process and characteristics may enable researchers to evaluate telehealth while enhancing rather than compromising the quality of an RCT, where research results are returned to practice as part of the research process. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, reference ACTRN12610000269033 .

Patient resistance as a resource: candidate obstacles in diabetes consultations.

This study uses conversation analysis to explore 'candidate obstacles', a practice observed in sequences of patient resistance to lifestyle advice within health professional consultations. This article presents illustrative analyses of selected data excerpts drawn from audio-visual recordings of 116 tracked consultations between health professionals and 34 patients newly diagnosed with type 2 diabetes mellitus in New Zealand. The analysis shows that in consultations where health promotion activities are central, patient resistance can provide space for patients to identify obstacles to their compliance with lifestyle advice. Identifying candidate obstacles provides opportunities for health professionals to align advice with concerns of patients and potentially improve patient outcomes.

Patients' engagement in primary care: powerlessness and compounding jeopardy. A qualitative study.

BACKGROUND: Primary health care does not adequately respond to populations known to have high needs such as those with compounding jeopardy from chronic conditions, poverty, minority status and age; as such populations report powerlessness. OBJECTIVE: To explore what poor older adults with chronic conditions who mostly belong to ethnic minority groups say they want from clinicians. SETTING AND PARTICIPANTS: Participants were older adults whose chronic conditions were severe enough to require hospital admission more than twice in the previous 12 months. All participants lived in poor localities in Auckland, New Zealand's largest city. METHODS: Forty-two in-depth interviews were conducted and analysed using qualitative description. RESULTS: An outward acceptance of health care belied an underlying dissatisfaction with low engagement. Participants did not feel heard and wanted information conveyed in a way that indicated clinicians understood them in the context of their lives. Powerlessness, anger, frustration and non-concordance were frequent responses. DISCUSSION AND CONCLUSIONS: Despite socio-cultural and disease-related complexity, patients pursue the (unrealised) ideal of an engaged therapeutic relationship with an understanding clinician. Powerlessness means that the onus is upon the health system and the clinician to engage. Engagement means building a relationship on the basis of social, cultural and clinical knowledge and demonstrating a shift in the way clinicians choose to think and interact in patient care. Respectful listening and questioning can deepen clinicians' awareness of patients' most important concerns. Enabling patients to direct the consultation is a way to integrate clinician expertise with what patients need and value.

Practitioner perspectives from seven health professional groups on core competencies in the context of chronic care.

The prevalence of chronic illness is growing worldwide and management is increasingly undertaken by interprofessional teams, yet education is still generally provided in separate professions. The aim of this study was to explore the perspectives of New Zealand healthcare practitioners from seven professional groups involved in chronic care (general practice medicine, nursing, occupational therapy, pharmacy, physiotherapy, social work, and speech language therapy) on the core competencies required of those working in this area. The study was set in the context of the chronic care and shared decision-making (SDM) models. The core competencies for chronic care practitioners proposed by the World Health Organisation were used to shape the research questions. Focus groups with expert clinicians (n = 20) and semi-structured interviews with practitioners (n = 32) were undertaken. Findings indicated a high level of agreement that the core competencies were appropriate and relevant for chronic care practitioners but that many educational and practice gaps existed and interprofessional education in New Zealand was not currently addressing these gaps. Among the key issues highlighted for attention by educators and policy-makers were the following: teams and teamwork, professional roles and responsibilities, interprofessional communication, cultural competence, better engagement with patients, families, and carers, and common systems, information sharing and confidentiality.

Post-consultation acute respiratory tract infection recovery: a latent class-informed analysis of individual patient data.

BACKGROUND: There is a lack of evidence regarding post-consultation symptom trajectories for patients with respiratory tract infections (RTIs) and whether patient characteristics can be used to predict illness duration. AIM: To describe symptom trajectories in patients with RTIs, and assess baseline characteristics and adverse events associated with trajectories. DESIGN AND SETTING: The study included data about 9103 adults and children from 12 primary care studies. METHOD: A latent class-informed regression analysis of individual patient data from randomised controlled trials and observational cohort studies was undertaken. Post-consultation symptom trajectory (severity and duration), re-consultation with same or worsening illness, and admission to hospital were assessed. RESULTS: In total, 90% of participants recovered from all symptoms by 28 days, regardless of antibiotic prescribing strategy (none, immediate, and delayed antibiotics). For studies of RTI with cough as a dominant symptom (n = 5314), four trajectories were identified: 'rapid (6 days)' (90% of participants recovered within 6 days) in 52.0%; 'intermediate (10 days)' (28.9%); 'slow progressive improvement (27 days)' (12.5%); and 'slow improvement with initial high symptom burden (27 days)' (6.6%). For cough, being aged 16-64 years (odds ratio [OR] 2.57, 95% confidence interval [CI] = 1.72 to 3.85 compared with <16 years), higher presenting illness baseline severity (OR 1.51, 95% CI = 1.12 to 2.03), presence of lung disease (OR 1.78, 95% CI = 1.44 to 2.21), and median and above illness duration before consultation (≥7 days) (OR 1.99, 95% CI = 1.68 to 2.37) were associated with slower recovery (>10 days) compared with faster recovery (≤10 days). Re-consultations and admissions to hospital for cough were higher in those with slower recovery (ORs: 2.15, 95% CI = 1.78 to 2.60 and 7.42, 95% CI = 3.49 to 15.78, respectively). CONCLUSION: Older patients presenting with more severe, longer pre-consultation symptoms and chronic lung disease should be advised they are more likely to experience longer post-consultation illness durations, and that recovery rates are similar with and without antibiotics.

Prediction of fat-free mass in young children using bioelectrical impedance spectroscopy.

BACKGROUND: Bioimpedance devices are practical for measuring body composition in preschool children, but their application is limited by the lack of validated equations. OBJECTIVES: To develop and validate fat-free mass (FFM) bioimpedance prediction equations among New Zealand 3.5-year olds, with dual-energy X-ray absorptiometry (DXA) as the reference method. METHODS: Bioelectrical impedance spectroscopy (SFB7, ImpediMed) and DXA (iDXA, GE Lunar) measurements were conducted on 65 children. An equation incorporating weight, sex, ethnicity, and impedance was developed and validated. Performance was compared with published equations and mixture theory prediction. RESULTS: The equation developed in ~70% (n = 45) of the population (FFM [kg] = 1.39 + 0.30 weight [kg] + 0.39 length2/resistance at 50 kHz [cm2/Ω] + 0.30 sex [M = 1/F = 0] + 0.28 ethnicity [1 = Asian/0 = non-Asian]) explained 88% of the variance in FFM and predicted FFM with a root mean squared error of 0.39 kg (3.4% of mean FFM). When internally validated (n = 20), bias was small (40 g, 0.3% of mean FFM), with limits of agreement (LOA) ±7.6% of mean FFM (95% LOA: -0.82, 0.90 kg). Published equations evaluated had similar LOA, but with marked bias (>12.5% of mean FFM) when validated in our cohort, likely due to DXA differences. Of mixture theory methods assessed, the SFB7 inbuilt equation with personalized body geometry values performed best. However, bias and LOA were larger than with the empirical equations (-0.43 kg [95% LOA: -1.65, 0.79], p < 0.001). CONCLUSIONS: We developed and validated a bioimpedance equation that can accurately predict FFM. Further external validation of the equation is required.

The effect of a preconception and antenatal nutritional supplement on children's BMI and weight gain over the first 2 years of life: findings from the NiPPeR randomised controlled trial.

BACKGROUND: Nutritional intervention before and throughout pregnancy might promote healthy infant weight gain; however, clinical evidence is scarce. Therefore, we examined whether preconception and antenatal supplementation would affect the body size and growth of children in the first 2 years of life. METHODS: Women were recruited from the community before conception in the UK, Singapore, and New Zealand, and randomly allocated to either the intervention (myo-inositol, probiotics, and additional micronutrients) or control group (standard micronutrient supplement) with stratification by site and ethnicity. Measurements of weight and length were obtained from 576 children at multiple timepoints in the first 2 years of life. Differences in age and sex standardised BMI at age 2 years (WHO standards) and the change in weight from birth were examined. Written informed consent was obtained from the mothers, and ethics approval was granted by local committees. The NiPPeR trial was registered with ClinicalTrials.gov (NCT02509988) on July 16, 2015 (Universal Trial Number U1111-1171-8056). FINDINGS: 1729 women were recruited between Aug 3, 2015, and May 31, 2017. Of the women randomised, 586 had births at 24 weeks or more of gestation between April, 2016, and January, 2019. At age 2 years, adjusting for study site, infant sex, parity, maternal smoking, maternal prepregnancy BMI, and gestational age, fewer children of mothers who received the intervention had a BMI of more than the 95th percentile (22 [9%] of 239 vs 44 [18%] of 245, adjusted risk ratio 0·51, 95% CI 0·31-0·82, p=0·006). Longitudinal data revealed that the children of mothers who received the intervention had a 24% reduced risk of experiencing rapid weight gain of more than 0·67 SD in the first year of life (58 [21·9%] of 265 vs 80 [31·1%] of 257, adjusted risk ratio 0·76, 95% CI 0·58-1·00, p=0·047). Risk was likewise decreased for sustained weight gain of more than 1·34 SD in the first 2 years (19 [7·7%] of 246 vs 43 [17·1%] of 251, adjusted risk ratio 0·55, 95% CI 0·34-0·88, p=0·014). INTERPRETATION: Rapid weight gain in infancy is associated with future adverse metabolic health. The intervention supplement taken before and throughout pregnancy was associated with lower risk of rapid weight gain and high BMI at age 2 years among children. Long-term follow-up is required to assess the longevity of these benefits. FUNDING: National Institute for Health Research; New Zealand Ministry of Business, Innovation and Employment; Société Des Produits Nestlé; UK Medical Research Council; Singapore National Research Foundation; National University of Singapore and the Agency of Science, Technology and Research; and Gravida.

Time-to-conception and clinical pregnancy rate with a myo-inositol, probiotics, and micronutrient supplement: secondary outcomes of the NiPPeR randomized trial.

OBJECTIVE: To determine whether a combined myo-inositol, probiotics and micronutrient nutritional supplement impacts time-to-natural-conception and clinical pregnancy rates. DESIGN: Secondary outcomes of a double-blind randomized controlled trial. SETTING: Community recruitment. PATIENTS: Women aged 18 to 38 years planning to conceive in the United Kingdom, Singapore, and New Zealand, excluding those with diabetes mellitus or receiving fertility treatment. INTERVENTION: A standard (control) supplement (folic acid, iron, calcium, iodine, ß-carotene), compared with an intervention additionally containing myo-inositol, probiotics, and other micronutrients (vitamins B2, B6, B12, D, zinc). MAIN OUTCOME MEASURES: Number of days between randomization and estimated date of natural conception of a clinical pregnancy, as well as cumulative pregnancy rates at 3, 6, and 12 months. RESULTS: Of 1729 women randomized, 1437 (83%; intervention, n=736; control, n=701) provided data. Kaplan-Meier curves of conception were similar between intervention and control groups; the time at which 20% achieved natural conception was 90.5 days (95% confidence interval: 80.7, 103.5) in the intervention group compared with 92.0 days (76.0, 105.1) in the control group. Cox's proportional hazard ratios (HRs) comparing intervention against control for cumulative achievement of pregnancy (adjusted for site, ethnicity, age, body mass index, and gravidity) were similar at 3, 6, and 12 months. Among both study groups combined, overall time-to-conception lengthened with higher preconception body mass index, and was longer in non-White than in White women. Among women who were overweight the intervention shortened time-to-conception compared with control regardless of ethnicity (12-month HR=1.47 [1.07, 2.02], P=.016; 20% conceived by 84.5 vs. 117.0 days) and improved it to that comparable to nonoverweight/nonobese women (20% conceived by 82.1 days). In contrast, among women with obesity, time-to-conception was lengthened with intervention compared with control (12-month HR=0.69 [0.47, 1.00]; P=.053; 20% conceived by 132.7 vs. 108.5 days); an effect predominantly observed in non-White women with obesity. CONCLUSIONS: Time-to-natural-conception and clinical pregnancy rates within a year were overall similar in women receiving the intervention supplement compared with control. Overweight women had a longer time-to-conception but there was suggestion that the supplement may shorten their time-to-conception to that comparable to the nonoverweight/nonobese women. Further studies are required to confirm this. CLINICAL TRIAL REGISTRATION NUMBER: clinicaltrials.gov (NCT02509988).