Impact of Gestational Diabetes Detection Thresholds on Infant Growth and Body Composition: A Prospective Cohort Study Within a Randomized Trial.

OBJECTIVE: Gestational diabetes mellitus (GDM) is associated with offspring metabolic disease, including childhood obesity, but causal mediators remain to be established. We assessed the impact of lower versus higher thresholds for detection and treatment of GDM on infant risk factors for obesity, including body composition, growth, nutrition, and appetite. RESEARCH DESIGN AND METHODS: In this prospective cohort study within the Gestational Diabetes Mellitus Trial of Diagnostic Detection Thresholds (GEMS), pregnant women were randomly allocated to detection of GDM using the lower criteria of the International Association of Diabetes and Pregnancy Study Groups or higher New Zealand criteria (ACTRN12615000290594). Randomly selected control infants of women without GDM were compared with infants exposed to A) GDM by lower but not higher criteria, with usual treatment for diabetes in pregnancy; B) GDM by lower but not higher criteria, untreated; or C) GDM by higher criteria, treated. The primary outcome was whole-body fat mass at 5-6 months. RESULTS: There were 760 infants enrolled, and 432 were assessed for the primary outcome. Fat mass was not significantly different between control infants (2.05 kg) and exposure groups: A) GDM by lower but not higher criteria, treated (1.96 kg), adjusted mean difference (aMD) -0.09 (95% CI -0.29, 0.10); B) GDM by lower but not higher criteria, untreated (1.94 kg), aMD -0.15 (95% CI -0.35, 0.06); and C) GDM detected and treated using higher thresholds (1.87 kg), aMD -0.17 (95% CI -0.37, 0.03). CONCLUSIONS: GDM detected using lower but not higher criteria, was not associated with increased infant fat mass at 5-6 months, regardless of maternal treatment. GDM detected and treated using higher thresholds was also not associated with increased fat mass at 5-6 months.

Sociodemographic and Health Indicators of Diet Quality in Pre-Frail Older Adults in New Zealand.

This study aimed to identify sociodemographic and health indicators of diet quality in pre-frail community-dwelling older adults. Pre-frail older adults are those at risk of progression to clinical manifestations of frailty and are targets for preventative intervention. We previously reported that pre-frail older adults have reasonably good overall diet quality. However, further analyses found a low intake of energy, protein and several micronutrients. METHODS: We collected detailed dietary intake from pre-frail (FRAIL scale 1-2) older adults using NZ Intake24, an online version of 24 h multiple pass dietary recall. Diet quality was ascertained with the Diet Quality Index-International (DQI-I). We used regression generalized linear models to determine predictors of diet quality as well as classification and regression tree (CART) analysis to examine the complex relationships between predictors and identified profiles of sub-groups of older adults that predict diet quality. RESULTS: The median age in this sample (n = 468) was 80.0 years (77.0-84.0). Living with others, a high deprivation index and a higher BMI were independent predictors of poorer diet quality. With CART analysis, we found that those with a BMI > 29 kg/m2, living with others and younger than 80 years were likely to have a lower diet quality. CONCLUSIONS: We found that BMI, living arrangement and socioeconomic status were independent predictors of diet quality in pre-frail older adults, with BMI being the most important variable in this sample when the interaction of these variables was considered. Future research is needed to determine the similarities and/or differences in the profile of subgroups of older adults with poorer diet quality.

Lower versus Higher Glycemic Criteria for Diagnosis of Gestational Diabetes.

BACKGROUND: Treatment of gestational diabetes improves maternal and infant health, although diagnostic criteria remain unclear. METHODS: We randomly assigned women at 24 to 32 weeks' gestation in a 1:1 ratio to be evaluated for gestational diabetes with the use of lower or higher glycemic criteria for diagnosis. The lower glycemic criterion was a fasting plasma glucose level of at least 92 mg per deciliter (≥5.1 mmol per liter), a 1-hour level of at least 180 mg per deciliter (≥10.0 mmol per liter), or a 2-hour level of at least 153 mg per deciliter (≥8.5 mmol per liter). The higher glycemic criterion was a fasting plasma glucose level of at least 99 mg per deciliter (≥5.5 mmol per liter) or a 2-hour level of at least 162 mg per deciliter (≥9.0 mmol per liter). The primary outcome was the birth of an infant who was large for gestational age (defined as a birth weight above the 90th percentile according to Fenton-World Health Organization standards). Secondary outcomes were maternal and infant health. RESULTS: A total of 4061 women underwent randomization. Gestational diabetes was diagnosed in 310 of 2022 women (15.3%) in the lower-glycemic-criteria group and in 124 of 2039 women (6.1%) in the higher-glycemic-criteria group. Among 2019 infants born to women in the lower-glycemic-criteria group, 178 (8.8%) were large for gestational age, and among 2031 infants born to women in the higher-glycemic-criteria group, 181 (8.9%) were large for gestational age (adjusted relative risk, 0.98; 95% confidence interval, 0.80 to 1.19; P = 0.82). Induction of labor, use of health services, use of pharmacologic agents, and neonatal hypoglycemia were more common in the lower-glycemic-criteria group than in the higher-glycemic-criteria group. The results for the other secondary outcomes were similar in the two trial groups, and there were no substantial between-group differences in adverse events. Among the women in both groups who had glucose test results that fell between the lower and higher glycemic criteria, those who were treated for gestational diabetes (195 women), as compared with those who were not (178 women), had maternal and infant health benefits, including fewer large-for-gestational-age infants. CONCLUSIONS: The use of lower glycemic criteria for the diagnosis of gestational diabetes did not result in a lower risk of a large-for-gestational-age infant than the use of higher glycemic criteria. (Funded by the Health Research Council of New Zealand and others; GEMS Australian New Zealand Clinical Trials Registry number, ACTRN12615000290594.).

Effectiveness of a complex intervention of group-based nutrition and physical activity to prevent frailty in pre-frail older adults (SUPER): a randomised controlled trial.

BACKGROUND: The increasing prevalence of frailty with age is becoming a public health priority in countries with ageing populations. Pre-frailty presents a window of opportunity to prevent the development of frailty in community-dwelling older adults. This study aimed to examine the effectiveness of a complex intervention that combined a nutrition-based intervention and a physical activity intervention, along with the effectiveness of each intervention individually, to reduce physical frailty in pre-frail older adults over 2 years. METHODS: In this single-blind, 2 x 2 factorial, randomised, controlled trial, we recruited pre-frail community-dwelling older adults in Aotearoa New Zealand via mail through general medical practices. To be eligible, participants had to be pre-frail according to self-reported FRAIL scores of 1 or 2, aged 75 years or older (or 60 years or older for Maori and Pacific Peoples), not terminally ill or with advanced dementia as judged by a general practitioner, able to stand, medically safe to participate in low-intensity exercise, and able to use kitchen utensils safely. Participants were randomly allocated to receive an 8-week Senior Chef programme (SC group), a 10-week Steady As You Go programme (SAYGO group), a 10-week combined SC and SAYGO intervention (combined group), or a 10-week social programme (control group), using computer-generated block randomisation administered through an electronic data capture system by local study coordinators. Assessors were masked to group allocation for all assessments. SC is a group-based nutrition education and cooking class programme (3 h weekly), SAYGO is a group-based strength and balance exercise programme (1 h weekly), and the social control programme was a seated, group socialising activity (once a week). Masked assessors ascertained Fried frailty scores at baseline, end of intervention, and at 6, 12, and 24 months after the programme. The primary outcome was change in Fried frailty score at 2 years. Intention-to-treat analyses were completed for all randomised participants, and all participants who had a high (≥75%) adherence were analysed per protocol. This study is registered at ANZCTR, ACTRN12614000827639. FINDINGS: Between May 12, 2016 and April 9, 2018, we assessed 2678 older adults for eligibility, of whom 468 (17%) consented and completed baseline assessment, with a mean age of 80·3 years (SD 5·1) and a mean Fried score of 1·9 (1·2); 59% were women. We randomly allocated these participants into the four groups: 117 in the SC group, 118 in the SAYGO group, 118 in the combined group, and 115 in the control group; 318 participants attended the 24-month follow-up: 89 in the SC group, 78 in the SAYGO group, 73 in the combined group, and 78 in the control group. At the 24-month follow-up, there were no differences in mean Fried scores between the intervention groups and the control group. No adverse events were reported. INTERPRETATION: The study did not find that the combined SC and SAYGO programme was effective in reducing frailty in pre-frail older adults. Although some short-term benefits were observed in each individual programme, there was no clear evidence of long-term impact. Further research is needed to evaluate combinations of group-based programmes for community-dwelling older adults to optimise their physical function. FUNDING: Health Research Council New Zealand and Ageing Well Challenge (Ministry of Business Innovation and Employment).

Prophylactic Oral Dextrose Gel and Neurosensory Impairment at 2-Year Follow-up of Participants in the hPOD Randomized Trial.

Importance: Prophylactic oral dextrose gel reduces neonatal hypoglycemia, but later benefits or harms remain unclear. Objective: To assess the effects on later development of prophylactic dextrose gel for infants born at risk of neonatal hypoglycemia. Design, Setting, and Participants: Prospective follow-up of a multicenter randomized clinical trial conducted in 18 Australian and New Zealand hospitals from January 2015 to May 2019. Participants were late preterm or term at-risk infants; those randomized in 9 New Zealand centers (n = 1359) were included and followed up between January 2017 and July 2021. Interventions: Infants were randomized to prophylactic 40% dextrose (n = 681) or placebo (n = 678) gel, 0.5 mL/kg, massaged into the buccal mucosa 1 hour after birth. Main Outcomes and Measures: The primary outcome of this follow-up study was neurosensory impairment at 2 years' corrected age. There were 44 secondary outcomes, including cognitive, language, and motor composite Bayley-III scores (mean [SD], 100 [15]; higher scores indicate better performance). Results: Of eligible infants, 1197 (91%) were assessed (581 females [49%]). Neurosensory impairment was not significantly different between the dextrose and placebo gel groups (20.8% vs 18.7%; unadjusted risk difference [RD], 2.09% [95% CI, -2.43% to 6.60%]; adjusted risk ratio [aRR], 1.13 [95% CI, 0.90 to 1.41]). The risk of cognitive and language delay was not significantly different between the dextrose and placebo groups (cognitive: 7.6% vs 5.3%; RD, 2.32% [95% CI, -0.46% to 5.11%]; aRR, 1.40 [95% CI, 0.91 to 2.17]; language: 17.0% vs 14.7%; RD, 2.35% [95% CI, -1.80% to 6.50%]; aRR, 1.19 [95% CI, 0.92 to 1.54]). However, the dextrose gel group had a significantly higher risk of motor delay (2.5% vs 0.7%; RD, 1.81% [95% CI, 0.40% to 3.23%]; aRR, 3.79 [95% CI, 1.27 to 11.32]) and significantly lower composite scores for cognitive (adjusted mean difference [aMD], -1.30 [95% CI, -2.55 to -0.05]), language (aMD, -2.16 [95% CI, -3.86 to -0.46]), and motor (aMD, -1.40 [95% CI, -2.60 to -0.20]) performance. There were no significant differences between groups in the other 27 secondary outcomes. Conclusions and Relevance: Among late preterm and term infants born at risk of neonatal hypoglycemia, prophylactic oral 40% dextrose gel at 1 hour of age, compared with placebo, resulted in no significant difference in the risk of neurosensory impairment at 2 years' corrected age. However, the study may have been underpowered to detect a small but potentially clinically important increase in risk, and further research including longer-term follow-up is required. Trial Registration: anzctr.org.au Identifier: ACTRN12614001263684.

Suicide preceded by health services contact - A whole-of-population study in New Zealand 2013-2015.

New Zealand's rate of suicide persistently exceeds the global average. The burden of suicide in New Zealand is disproportionately borne by youth, males and Maori (NZ indigenous people). While the demographic characteristics of suicide decedents are established, there is a need to identify potential points of contact with health services where preventative action could take place. This paper aims to determine if suicide deaths in New Zealand were likely to be preceded by contact with health services, and the type and time frame in which these contacts took place. This study utilised a whole-of-population-cohort of all individuals age 15 years and over, who were alive on March 5th 2013, followed up to December 2015. Associations between the odds of suicide, demographic factors, area-based deprivation, and the timing of last contact with primary, secondary, and tertiary services were analysed using univariate and multivariate logistic regression. Contact with a health service in the 6 Months prior to death was associated with the highest odds of suicide. Over half of the suicide decedent population (59.4%) had contacted primary health services during this period. Large proportions of the suicide decedent population contacted secondary and tertiary services in the 6 Months prior to death, 46.5% and 30.4% respectively. Contact with primary, secondary and tertiary services in the prior 6 Months, were associated with an increased odds of suicide of 2.51 times [95% CI 2.19-2.88], 4.45 times [95% CI 3.69-4.66] and 6.57 times [95% CI 5.84-7.38], respectively, compared to those who had no health services contact.

Costs of inpatient hospitalisations in the last year of life in older New Zealanders: a cohort study.

BACKGROUND: Rapidly ageing populations means that many people now die in advanced age. This paper investigated public hospital and long-term care home costs in the 12 months before death in Maori and non-Maori of advanced age in New Zealand. METHODS: Data from an existing longitudinal study (LiLACS NZ) was used, in which 937 older New Zealanders were enrolled in 2010. At the time of this study, 213 Maori and 241 non-Maori in the cohort had died. National Health Index numbers were linked to the hospitalisation National Minimum Dataset to ascertain public hospitalisation and care home costs in the last year of life. RESULTS: The average total publicly funded hospital and long-term care home costs in the 12 months prior to death were $16,211 and $17,351 for Maori and non-Maori respectively. Non-Maori tended to have long lengths of stay in their last year of life, and non-Maori men had the highest proportion with high costs and long lengths of stay in care homes. Costs in the last year of life were 8.1 times higher in comparison to costs for individuals who did not die in the same time period. CONCLUSION: Despite New Zealand's commitment to providing an equitable level of healthcare, this study illustrated that ethnic and gender disparities are still apparent at the end of life. This raises questions as to whether money at the end of life is being spent appropriately, and how it could potentially be more equitably targeted to meet the diverse needs of older people and their families.

The Diet Quality and Nutrition Inadequacy of Pre-Frail Older Adults in New Zealand.

This study aimed to describe the diet quality of pre-frail community-dwelling older adults to extend the evidence of nutrition in frailty prevention. Pre-frailty, the transition state between a robust state and frailty, was ascertained using the FRAIL scale. Socio-demographic, health status, and 24-h dietary recalls were collected from 465 community-dwelling adults aged 75+ (60 years for Maori and Pacific people) across New Zealand. Diet quality was ascertained with the Diet Quality Index-International (DQI-I). Participants (median (IQR) age 80 (77-84), 59% female) had a moderately healthful diet, DQI-I score: 60.3 (54.0-64.7). Women scored slightly higher than men (p = 0.042). DQI-I components identified better dietary variety in men (p = 0.044), and dietary moderation in women (p = 0.002); both sexes performed equally well in dietary adequacy and poorly in dietary balance scores (73% and 47% of maximum scores, respectively). Low energy 20.3 (15.4-25.3) kcal/kg body weight (BW) and protein intakes 0.8 (0.6-1.0) g/kg BW were coupled with a high prevalence of mineral inadequacies: calcium (86%), magnesium (68%), selenium (79%), and zinc (men 82%). In conclusion, the diet quality of pre-frail older adults was moderately high in variety and adequacy but poor in moderation and balance. Our findings support targeted dietary interventions to ameliorate frailty.

Cost burden and net monetary benefit loss of neonatal hypoglycaemia.

BACKGROUND: Neonatal hypoglycaemia is a common but treatable metabolic disorder that affects newborn infants and which, if not identified and treated adequately, may result in neurological sequelae that persist for the lifetime of the patient. The long-term financial and quality-of-life burden of neonatal hypoglycaemia has not been previously examined. METHODS: We assessed the postnatal hospital and long-term costs associated with neonatal hypoglycaemia over 80 year and 18 year time horizons, using a health-system perspective and assessing impact on quality of life using quality-adjusted life year (QALYs). A decision analytic model was used to represent key outcomes in the presence and absence of neonatal hypoglycaemia. RESULTS: The chance of developing one of the outcomes of neonatal hypoglycaemia in our model (cerebral palsy, learning disabilities, seizures, vision disorders) was 24.03% in subjects who experienced neonatal hypoglycaemia and 3.56% in those who do did not. Over an 80 year time horizon a subject who experienced neonatal hypoglycaemia had a combined hospital and post-discharge cost of NZ$72,000 due to the outcomes modelled, which is NZ$66,000 greater than a subject without neonatal hypoglycaemia. The net monetary benefit lost due to neonatal hypoglycaemia, using a value per QALY of NZ$43,000, is NZ$180,000 over an 80 year time horizon. CONCLUSIONS: Even under the most conservative of estimates, neonatal hypoglycaemia contributes a significant financial burden to the health system both during childhood and over a lifetime. The combination of direct costs and loss of quality of life due to neonatal hypoglycaemia means that this condition warrants further research to focus on prevention and effective treatment.

Evaluation of oral dextrose gel for prevention of neonatal hypoglycemia (hPOD): A multicenter, double-blind randomized controlled trial.

BACKGROUND: Neonatal hypoglycemia is common and can cause brain injury. Buccal dextrose gel is effective for treatment of neonatal hypoglycemia, and when used for prevention may reduce the incidence of hypoglycemia in babies at risk, but its clinical utility remains uncertain. METHODS AND FINDINGS: We conducted a multicenter, double-blinded, placebo-controlled randomized trial in 18 New Zealand and Australian maternity hospitals from January 2015 to May 2019. Babies at risk of neonatal hypoglycemia (maternal diabetes, late preterm, or high or low birthweight) without indications for neonatal intensive care unit (NICU) admission were randomized to 0.5 ml/kg buccal 40% dextrose or placebo gel at 1 hour of age. Primary outcome was NICU admission, with power to detect a 4% absolute reduction. Secondary outcomes included hypoglycemia, NICU admission for hypoglycemia, hyperglycemia, breastfeeding at discharge, formula feeding at 6 weeks, and maternal satisfaction. Families and clinical and study staff were unaware of treatment allocation. A total of 2,149 babies were randomized (48.7% girls). NICU admission occurred for 111/1,070 (10.4%) randomized to dextrose gel and 100/1,063 (9.4%) randomized to placebo (adjusted relative risk [aRR] 1.10; 95% CI 0.86, 1.42; p = 0.44). Babies randomized to dextrose gel were less likely to become hypoglycemic (blood glucose < 2.6 mmol/l) (399/1,070, 37%, versus 448/1,063, 42%; aRR 0.88; 95% CI 0.80, 0.98; p = 0.02) although NICU admission for hypoglycemia was similar between groups (65/1,070, 6.1%, versus 48/1,063, 4.5%; aRR 1.35; 95% CI 0.94, 1.94; p = 0.10). There were no differences between groups in breastfeeding at discharge from hospital (aRR 1.00; 95% CI 0.99, 1.02; p = 0.67), receipt of formula before discharge (aRR 0.99; 95% CI 0.92, 1.08; p = 0.90), and formula feeding at 6 weeks (aRR 1.01; 95% CI 0.93, 1.10; p = 0.81), and there was no hyperglycemia. Most mothers (95%) would recommend the study to friends. No adverse effects, including 2 deaths in each group, were attributable to dextrose gel. Limitations of this study included that most participants (81%) were infants of mothers with diabetes, which may limit generalizability, and a less reliable analyzer was used in 16.5% of glucose measurements. CONCLUSIONS: In this placebo-controlled randomized trial, prophylactic dextrose gel 200 mg/kg did not reduce NICU admission in babies at risk of hypoglycemia but did reduce hypoglycemia. Long-term follow-up is needed to determine the clinical utility of this strategy. TRIAL REGISTRATION: ACTRN 12614001263684.

IVF and IUI in couples with unexplained infertility (FIIX study): study protocol of a non-inferiority randomized controlled trial.

STUDY QUESTIONS: In couples with unexplained infertility and a poor prognosis of natural conception, are four cycles of IUI with ovarian stimulation (IUI-OS) non-inferior to one completed cycle of IVF for the outcome of cumulative live birth? Are four cycles of IUI-OS associated with a lower cost per live birth compared to one completed cycle of IVF? Will four cycles of IUI-OS followed by one complete cycle of IVF result in as many live births at lower cost per live birth, than two complete cycles of IVF? Will four cycles of IUI-OS followed by two complete cycles of IVF result in more live births at lower cost per live birth, than two complete cycles of IVF alone? WHAT IS KNOWN ALREADY: IUI is widely used in the USA, the UK and Europe as a low cost, less invasive alternative to IVF for couples with unexplained infertility. Although three to six cycles of IUI were comparable to IVF in the three major studies carried out to date, gonadotrophin ovarian stimulation was used in the majority of cases, and this also resulted in a high multiple pregnancy rate in some studies. Ovarian stimulation with clomiphene citrate is known to have lower multiple pregnancy rates. STUDY DESIGN SIZE DURATION: The FIIX study is a multicentre, open label, parallel, pragmatic non-inferiority randomized controlled trial of 580 couples with unexplained infertility comparing four cycles of IUI-OS with clomiphene citrate and one completed cycle of IVF. Variable block randomization stratified by age and clinic with electronic allocation will be used. PARTICIPANTS/MATERIALS SETTING METHODS: Couples with poor prognosis for natural conception and who are eligible for publicly funded fertility treatment in six fertility clinics in New Zealand. STUDY FUNDING/COMPETING INTERESTS: Auckland Medical Research Fund (3718892/1119003), A+ Trust, Auckland District Health Board (A + 8479), Maurice and Phyllis Paykel Trust (3718514). No competing interests. TRIAL REGISTRATION NUMBER: ACTRN12619001003167. TRIAL REGISTRATION DATE: 15 July 2019. DATE OF FIRST PATIENT'S ENROLMENT: 02/08/2019.

Comparison of risk-of-bias assessment approaches for selection of studies reporting prevalence for economic analyses.

OBJECTIVES: Within cost-effectiveness models, prevalence figures can inform transition probabilities. The methodological quality of studies can inform the choice of prevalence figures but no single obvious candidate tool exists for assessing quality of the observational epidemiological studies for selecting prevalence estimates. We aimed to compare different tools to assess the risk of bias of studies reporting prevalence, and develop and compare possible numerical scoring systems using these tools to set a threshold for inclusion of reports of prevalence in an economic analysis of neonatal hypoglycaemia. DESIGN: Assessments of bias using two tools (Joanna Briggs Institute (JBI) Checklist for Prevalence Studies and a modified version of Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I)) were compared for 18 studies relevant to a single setting (neonatal hypoglycaemia). Inclusions of studies for use in a decision analysis model were considered based on summary scores derived from these tools. RESULTS: Both tools were considered easy to use and produced dispersed scores for each of the 40 study-outcome combinations. The modified ROBINS-I scores were more skewed than the JBI scores, particularly at higher thresholds. The studies selected for inclusion are generally the same using either tool; if 50% was used as the cut-off threshold using the Applicable Score both tools would yield the same results. However, the JBI tool is shorter and may be easier to interpret and apply to studies that do not involve a control group, while the modified ROBINS-I tool assesses more methodological detail in studies that include a control group. CONCLUSION: Both tools performed well for systematically assessing studies that report on outcome prevalence and provided similar discrimination between studies for risk of bias. This convergent validity supports use of both tools for the purpose of assessing risk of bias and selecting studies that report prevalence for inclusion in economic analyses.

Lower versus higher diagnostic criteria for the detection of gestational diabetes for reducing maternal and perinatal morbidity: study protocol for the GEMS randomised trial.

BACKGROUND: Gestational diabetes mellitus (GDM) has lifelong implications for the woman and her infant. Treatment reduces adverse maternal and perinatal outcomes although uncertainty remains about the optimal diagnostic criteria. The GEMS Trial aims to assess whether detection and treatment of women with GDM using the lower International Association of Diabetes in Pregnancy Study Groups diagnostic criteria compared with the higher criteria recommended in New Zealand reduces infant morbidity without increasing maternal morbidity. METHODS: GEMS is a multicentre, randomised trial. Women with a singleton pregnancy at 24 to 34 weeks' gestation are eligible who give written informed consent. Women are randomly allocated to the Lower Criteria Group or the Higher Criteria Group. Women with a normal OGTT by their allocated criteria receive routine care (Higher criteria: fasting plasma glucose < 5.5 mmol/L, AND 2 hour < 9.0 mmol/L; Lower criteria: fasting plasma glucose < 5.1 mmol/L, AND 1 hour < 10.0 mmol/L, AND 2 hour < 8.5 mmol/l). Women with GDM on OGTT by their allocated criteria receive standard care for GDM (Higher criteria: fasting plasma glucose ≥ 5.5 mmol/L, OR 2 hour ≥ 9.0 mmol/L; Lower criteria: fasting plasma glucose ≥ 5.1 mmol/L, OR 1 hour ≥ 10.0 mmol/L, OR 2 hour ≥ 8.5 mmol/L). The primary outcome is large for gestational age (birth weight > 90th centile). Secondary outcomes for the infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score < 4 at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity. A study with 4,158 women will detect an absolute difference of 2.9% in the proportion of large for gestational age infants from 10.0% using the lower criteria to 12.9% with the higher criteria. DISCUSSION: The GEMS Trial will provide high-level evidence relevant for clinical practice. If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry registration number ACTRN12615000290594 . Date registered: 27th March 2015.

Cost-Utility Analysis of Prophylactic Dextrose Gel vs Standard Care for Neonatal Hypoglycemia in At-Risk Infants.

OBJECTIVE: To evaluate the long-term costs and impact on quality of life of using prophylactic dextrose gel in patients at increased risk of developing neonatal hypoglycemia. STUDY DESIGN: A cost-utility analysis was performed from the perspective of the health system, using a decision tree to model the long-term clinical outcomes of neonatal hypoglycemia, including cerebral palsy, epilepsy, vision disturbances, and learning disabilities, in patients at increased risk of neonatal hypoglycemia who received prophylactic dextrose gel vs standard care. Model parameters including likelihoods of hypoglycemia and admission to a neonatal intensive care unit, were based on the pre-Hypoglycemia Prevention with Oral Dextrose Study. Estimations of the likelihood of long-term condition(s), and their costs, were based on review of published literature. RESULTS: Patients who received prophylactic dextrose gel incurred costs to the health system of around US $14 000 over an 18-year time horizon, accruing 11.25 quality-adjusted life-years, whereas those who did not receive prophylactic treatment incurred cost of around $16 000 and experienced a utility of 11.10 quality-adjusted life-years. CONCLUSIONS: A prophylactic strategy of using dextrose gel in infants at increased risk of neonatal hypoglycemia is likely to be cost effective compared with standard care, to reduce the direct costs to the health system over an 18-year time horizon, and improve quality of life.

Evaluating the effects of an exercise program (Staying UpRight) for older adults in long-term care on rates of falls: study protocol for a randomised controlled trial.

BACKGROUND: Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively. METHODS/DESIGN: This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018. DISCUSSION: This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148.

Caregiving, ethnicity and gender in Maori and non-Maori New Zealanders of advanced age: Findings from LiLACS NZ Kaiawhina (Love and Support) study.

OBJECTIVE: This study investigates sex and ethnicity in relationships of care using data from Wave 4 of LiLACS NZ, a longitudinal study of Maori and non-Maori New Zealanders of advanced age. METHODS: Informal primary carers for LiLACS NZ participants were interviewed about aspects of caregiving. Data were analysed by gender and ethnic group of the LiLACS NZ participant. RESULTS: Carers were mostly adult children or partners, and three-quarters of them were women. Maori and men received more hours of care with a higher estimated dollar value of care. Maori men received the most personal care and household assistance. Carer employment, self-rated health, quality of life and impact of caring did not significantly relate to the gender and ethnicity of care recipients. CONCLUSIONS: Gender and ethnicity are interwoven in caregiving and care receiving. Demographic differences and cultural expectations in both areas must be considered in policies for carer support.

Anal fistula plug versus surgeon's preference for surgery for trans-sphincteric anal fistula: the FIAT RCT.

BACKGROUND: The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis® anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported. OBJECTIVES: To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas. DESIGN: A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial. SETTING: Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland. PARTICIPANTS: Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin. INTERVENTIONS: Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon's preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure]. MAIN OUTCOME MEASURES: The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness. RESULTS: Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon's preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon's preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon's preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35-45% chance that the fistula plug was as cost-effective as surgeon's preference over a range of thresholds of willingness to pay for a single QALY of £20,000-30,000. LIMITATIONS: Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up. CONCLUSIONS: The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS. FUTURE WORK: Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78352529. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.

Fistula-in-ano is a common condition in which the inside of the anus is in communication with the outside skin. It is a cause of long-term suffering owing to recurrent infection. Many surgical operations have been proposed to treat fistula-in-ano, with varying degrees of success. These carry the risk of faecal incontinence. The aim of the Fistula-In-Ano Trial (FIAT) was to assess the benefits of a new technology, the Surgisis^® anal fistula plug (Cook Medical, Bloomington, IN, USA), compared with other surgical techniques. The FIAT involved 304 participants; 152 participants were treated with the fistula plug and 152 participants were treated with an alternative surgical technique. There were no differences in quality of life (QoL) among participants treated with the fistula plug compared with those receiving other treatments when assessed 12 months following the operation. Successful fistula healing was achieved in 54% of fistula plug-treated participants and in 55% of participants treated with an alternative technique at 12 months following the operation. Few patients suffered from faecal incontinence before their operation and there was a slight improvement following treatment with the fistula plug and other surgical treatments. The only difference seen between the group treated with the fistula plug and those receiving other surgical treatments was in the complication rate at the 6-week assessment time, with the fistula plug group having higher rates of unexpected pain. Economic analysis of the fistula plug compared with the other surgical treatments showed that the fistula plug was more expensive and only produced very small improvements in QoL. On this basis, it is unlikely that decision-makers in the NHS will support the routine use of the fistula plug.