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"Edlin, Richard"
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Evaluation of oral dextrose gel for prevention of neonatal hypoglycemia (hPOD): A multicenter, double-blind randomized controlled trial
by
Alsweiler, Jane M.
,
Harding, Jane E.
,
Crowther, Caroline A.
in
Administration, Oral
,
Australia - epidemiology
,
Biology and Life Sciences
2021
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.
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.
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.
ACTRN 12614001263684.
Journal Article
Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations
by
Mauskopf, Josephine
,
Hiligsmann, Mickaël
,
Berger, Marc
in
Decision making
,
Economics
,
Health economics
2022
Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc.). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.
Journal Article
Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study)
by
Crowther, Caroline Anne
,
Edlin, Richard
,
Hegarty, Joanne Elizabeth
in
Administration, Oral
,
Babies
,
Biology and Life Sciences
2016
Neonatal hypoglycaemia is common, affecting up to 15% of newborns, and can cause brain damage. Currently, there are no strategies, beyond early feeding, to prevent neonatal hypoglycaemia. Our aim was to determine a dose of 40% oral dextrose gel that will prevent neonatal hypoglycaemia in newborn babies at risk.
We conducted a randomised, double-blind, placebo-controlled dose-finding trial of buccal dextrose gel to prevent neonatal hypoglycaemia at two hospitals in New Zealand. Babies at risk of hypoglycaemia (infant of a mother with diabetes, late preterm delivery, small or large birthweight, or other risk factors) but without indication for admission to a neonatal intensive care unit (NICU) were randomly allocated either to one of four treatment groups: 40% dextrose at one of two doses (0.5 ml/kg = 200 mg/kg, or 1 ml/kg = 400 mg/kg), either once at 1 h of age or followed by three additional doses of dextrose (0.5 ml/kg before feeds in the first 12 h); or to one of four corresponding placebo groups. Treatments were administered by massaging gel into the buccal mucosa. The primary outcome was hypoglycaemia (<2.6 mM) in the first 48 h. Secondary outcomes included admission to a NICU, admission for hypoglycaemia, and breastfeeding at discharge and at 6 wk. Prespecified potential dose limitations were tolerance of gel, time taken to administer, messiness, and acceptability to parents. From August 2013 to November 2014, 416 babies were randomised. Compared to babies randomised to placebo, the risk of hypoglycaemia was lowest in babies randomised to a single dose of 200 mg/kg dextrose gel (relative risk [RR] 0.68; 95% confidence interval [CI] 0.47-0.99, p = 0.04) but was not significantly different between dose groups (p = 0.21). Compared to multiple doses, single doses of gel were better tolerated, quicker to administer, and less messy, but these limitations were not different between dextrose and placebo gel groups. Babies who received any dose of dextrose gel were less likely to develop hypoglycaemia than those who received placebo (RR 0.79; 95% CI 0.64-0.98, p = 0.03; number needed to treat = 10, 95% CI 5-115). Rates of NICU admission were similar (RR 0.64; 95% CI 0.33-1.25, p = 0.19), but admission for hypoglycaemia was less common in babies randomised to dextrose gel (RR 0.46; 95% CI 0.21-1.01, p = 0.05). Rates of breastfeeding were similar in both groups. Adverse effects were uncommon and not different between groups. A limitation of this study was that most of the babies in the trial were infants of mothers with diabetes (73%), which may reduce the applicability of the results to babies from other risk groups.
The incidence of neonatal hypoglycaemia can be reduced with a single dose of buccal 40% dextrose gel 200 mg/kg. A large randomised trial (Hypoglycaemia Prevention with Oral Dextrose [hPOD]) is under way to determine the effects on NICU admission and later outcomes.
Australian New Zealand Clinical Trials Registry ACTRN12613000322730.
Journal Article
Suicide preceded by health services contact – A whole-of-population study in New Zealand 2013-2015
2021
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 Māori (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 5 th 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.
Journal Article
Comparison of risk-of-bias assessment approaches for selection of studies reporting prevalence for economic analyses
by
Edlin, Richard
,
Glasgow, Matthew J
,
Harding, Jane E
in
Bias
,
Cost-Benefit Analysis
,
Economic analysis
2020
ObjectivesWithin 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.DesignAssessments 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.ResultsBoth 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.ConclusionBoth 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.
Journal Article
Cost burden and net monetary benefit loss of neonatal hypoglycaemia
2021
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.
Journal Article
The cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy for low risk localised prostate cancer
by
Brown, Charis
,
Holmes, Michael
,
Edlin, Richard
in
Active surveillance
,
Aged
,
Biomedical and Life Sciences
2017
Background
Radical prostatectomy is the most common treatment for localised prostate cancer in New Zealand. Active surveillance was introduced to prevent overtreatment and reduce costs while preserving the option of radical prostatectomy. This study aims to evaluate the cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy.
Methods
Markov models were constructed to estimate the life-time cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy for low risk localised prostate cancer patients aged 45–70 years, using national datasets in New Zealand and published studies including the SPCG-4 study. This study was from the perspective of the Ministry of Health in New Zealand.
Results
Radical prostatectomy is less costly than active surveillance in men aged 45–55 years with low risk localised prostate cancer, but more costly for men aged 60–70 years. Scenario analyses demonstrated significant uncertainty as to the most cost-effective option in all age groups because of the unavailability of good quality of life data for men under active surveillance. Uncertainties around the likelihood of having radical prostatectomy when managed with active surveillance also affect the cost-effectiveness of active surveillance against radical prostatectomy.
Conclusions
Active surveillance is less likely to be cost-effective compared to radical prostatectomy for younger men diagnosed with low risk localised prostate cancer. The cost-effectiveness of active surveillance compared to radical prostatectomy is critically dependent on the ‘trigger’ for radical prostatectomy and the quality of life in men on active surveillance. Research on the latter would be beneficial.
Journal Article
Evaluation of oral dextrose gel for prevention of neonatal hypoglycemia
by
Crowther, Caroline A
,
Veitch, Emma
,
Harding, Jane E
in
Dextrose
,
Diseases
,
Dosage and administration
2021
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. 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. 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.
Journal Article
Costs of inpatient hospitalisations in the last year of life in older New Zealanders: a cohort study
2021
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 Māori and non-Māori 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 Māori and 241 non-Māori 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 Māori and non-Māori respectively. Non-Māori tended to have long lengths of stay in their last year of life, and non-Māori 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.
Journal Article
The Diet Quality and Nutrition Inadequacy of Pre-Frail Older Adults in New Zealand
2021
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 Māori 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.
Journal Article